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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04728893
Registration number
NCT04728893
Ethics application status
Date submitted
25/01/2021
Date registered
28/01/2021
Date last updated
7/06/2024
Titles & IDs
Public title
Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)
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Scientific title
A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies
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Secondary ID [1]
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0
MK-1026-003
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Secondary ID [2]
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1026-003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hematologic Malignancies
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0
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Waldenstroms Macroglobulinaemia
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0
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Non-Hodgkins Lymphoma
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Chronic Lymphocytic Leukaemia
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0
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Condition category
Condition code
Cancer
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0
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0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
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0
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Leukaemia - Acute leukaemia
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Cancer
0
0
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0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Nemtabrutinib
Experimental: Nemtabrutinib - Participants receive nemtabrutinib orally once daily (QD) until progressive disease (PD) or discontinuation.
Treatment: Drugs: Nemtabrutinib
Nemtabrutinib tablets administered PO QD.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Number of participants experiencing dose-limiting toxicities (DLTs)
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Assessment method [1]
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DLTs will be defined as toxicities observed during the first 2 cycles (8 weeks) of Part 1 and include: Grade =3 nonhematologic toxicity (except Grade 3 nausea, vomiting, diarrhea, rash, fatigue, and uncontrolled hypertension which will not be considered a DLT unless lasting =72 hours despite optimal supportive care); Grade 4 hematologic toxicity lasting >7 days (except Grade 3 lymphocytosis, Grade 4 platelet count decreased of any duration, or Grade 3 platelet count decreased if associated with bleeding); any Grade 3 or Grade 4 nonhematologic laboratory abnormality if values result in drug-induced liver injury, or medical intervention is required, or the abnormality leads to hospitalization, or the abnormality persists for >1 week (with exceptions); missing >25% of nemtabrutinib doses as a result of drug-related adverse events (AEs) during the first 2 cycles (8 weeks); Grade 5 toxicity.
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Timepoint [1]
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Up to ~56 days (Cycles 1-2, cycle = 28 days)
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Primary outcome [2]
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Part 1: Number of participants experiencing adverse events (AEs)
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Assessment method [2]
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An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing AEs will be reported for Part 1.
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Timepoint [2]
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Up to ~71 months
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Primary outcome [3]
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Part 1: Number of participants discontinuing study treatment due to AEs
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Assessment method [3]
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An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study treatment due to an AE will be reported for Part 1.
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Timepoint [3]
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Up to ~42 months
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Primary outcome [4]
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Part 2: Objective Response Rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria 2018 as assessed by independent central review (ICR)
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Assessment method [4]
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ORR per iwCLL 2018 criteria is defined as the percentage of participants achieving a complete response (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR), or partial response (PR). CR is defined as meeting the following criteria: no lymph nodes >1.5 cm, spleen size <13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets =100 x 10^9/L; hemoglobin =11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as =50% decrease in =2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS =1 of the following met: platelets =100 x 10^9/L or =50% increase from screening, hemoglobin >11 g/dL or =50% increase from screening, CLL cells or B lymphoid nodules in marrow.
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Timepoint [4]
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Up to ~61 months
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Primary outcome [5]
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Part 2: ORR per Lugano criteria 2014 as assessed by ICR
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Assessment method [5]
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ORR per Lugano criteria 2014 is defined as the percentage of participants achieving a CR or PR. CR defined as EITHER CR by imaging (computed tomography [CT]): all lymph nodes normal (none =15 mm) and normal liver and spleen OR complete metabolic response (CMR): score of 1, 2 or 3 on the 5-point scale assessing fluorodeoxyglucose (FDG) metabolic activity in lymphomatous lesions (ranging from 1=no uptake above background to 5=uptake markedly higher than liver) AND bone marrow (BM) normal by morphology. PR defined as EITHER PR by imaging (CT) with =50% decrease in the sum of the product of diameters [SPD] of target lesions, no worsening of nontarget lesions, no new lesions and =50% spleen abnormal portion OR Partial Metabolic Response (PMR) with score of 4 or 5 on the FDG 5-point scale (with no new lesions) and decreased overall uptake AND residual BM abnormalities; OR CR by imaging with residual BM abnormalities; OR PR by imaging without residual BM abnormalities.
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Timepoint [5]
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Up to ~61 months
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Primary outcome [6]
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Part 2: ORR per International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria 2014 as assessed by ICR
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Assessment method [6]
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ORR per IWWM criteria 2014 is defined as the percentage of participants achieving a CR, very good partial response (VGPR), or PR. CR is defined as all lymph nodes are normal in size (none =15 mm), liver and spleen normal in size, serum immunoglobulin M (IgM) values in the normal range, disappearance of monoclonal protein by immunofixation (confirmation needed with a second immunofixation at any subsequent timepoint), and no histological evidence of BM involvement. VGPR is defined as =50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), =50% decrease from baseline in the abnormal portion of the spleen (if previously abnormal), and =90% decrease from baseline in serum IgM, or serum IgM values in normal range. PR is defined as =50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), =50% decrease from baseline in serum IgM, and =50% decrease from baseline in the abnormal portion of the spleen (if previously abnormal).
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Timepoint [6]
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Up to ~71 months
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Secondary outcome [1]
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Part 1: Area Under the Curve (AUC) of Nemtabrutinib
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Assessment method [1]
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Blood samples will be obtained at designated time points during Part 1 for the assessment of nemtabrutinib AUC (Day 1 of Cycles 1 and 2: Pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2, 4, and 6 hours post-dose [up to ~57 days]). Each cycle is 28 days.
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Timepoint [1]
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At designated time points (up to ~57 days)
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Secondary outcome [2]
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Part 1: Minimum Concentration (Cmin) of Nemtabrutinib
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Assessment method [2]
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Blood samples will be obtained at designated time points during Part 1 for the assessment of nemtabrutinib Cmin (Day 1 of Cycles 1 and 2: Pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2, 4, and 6 hours post-dose [up to ~57 days]). Each cycle is 28 days.
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Timepoint [2]
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At designated time points (up to ~57 days)
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Secondary outcome [3]
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Part 1: Maximum Concentration (Cmax) of Nemtabrutinib
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Assessment method [3]
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Blood samples will be obtained at designated time points during Part 1 for the assessment of nemtabrutinib Cmax (Day 1 of Cycles 1 and 2: Pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2, 4, and 6 hours post-dose [up to ~57 days]). Each cycle is 28 days.
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Timepoint [3]
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At designated time points (up to ~57 days)
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Secondary outcome [4]
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Part 1: ORR per iwCLL criteria 2018 as assessed by ICR
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Assessment method [4]
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ORR per iwCLL 2018 criteria is defined as the percentage of participants achieving a CR, CRi, nPR, or PR. CR is defined as meeting the following criteria: no lymph nodes >1.5 cm, spleen size <13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets =100 x 10^9/L; hemoglobin =11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as =50% decrease in =2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS =1 of the following met: platelets =100 x 10^9/L or =50% increase from screening, hemoglobin >11 g/dL or =50% increase from screening, CLL cells or B lymphoid nodules in marrow.
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Timepoint [4]
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Up to ~71 months
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Secondary outcome [5]
0
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Part 1: Duration of Response (DOR) per iwCLL criteria 2018 as assessed by ICR
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Assessment method [5]
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For participants with CR, CRi, nPR, or PR per iwCLL 2018 criteria, DOR is defined as the time from the first documented evidence of objective response until PD or death due to any cause, whichever occurs first. CR is defined as meeting the following criteria: no lymph nodes >1.5 cm, spleen size <13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets =100 x 10^9/L; hemoglobin =11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as =50% decrease in =2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS =1 of the following met: platelets =100 x 10^9/L or =50% increase from screening, hemoglobin >11 g/dL or =50% increase from screening, CLL cells or B lymphoid nodules in marrow.
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Timepoint [5]
0
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Up to ~71 months
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Secondary outcome [6]
0
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Part 2: Number of participants experiencing AEs
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Assessment method [6]
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An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing AEs will be reported for Part 2.
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Timepoint [6]
0
0
Up to ~61 months
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Secondary outcome [7]
0
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Part 2: Number of participants discontinuing study treatment due to AEs
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Assessment method [7]
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An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study treatment due to an AE will be reported for Part 2.
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Timepoint [7]
0
0
Up to ~42 months
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Secondary outcome [8]
0
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Part 2: AUC of Nemtabrutinib
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Assessment method [8]
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Blood samples will be obtained at designated time points during Part 2 for the assessment of nemtabrutinib AUC (Day 1 of Cycles 1, 2, and 3: Pre-dose, 2, 4, 6, hours post-dose [up to ~57 days]). Each cycle is 28 days.
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Timepoint [8]
0
0
At designated time points (up to ~57 days)
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Secondary outcome [9]
0
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Part 2: Cmin of Nemtabrutinib
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Assessment method [9]
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Blood samples will be obtained at designated time points during Part 2 for the assessment of nemtabrutinib Cmin (Day 1 of Cycles 1, 2, and 3: Pre-dose, 2, 4, 6, hours post-dose [up to ~57 days]). Each cycle is 28 days.
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Timepoint [9]
0
0
At designated time points (up to ~57 days)
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Secondary outcome [10]
0
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Part 2: Cmax of Nemtabrutinib
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Assessment method [10]
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Blood samples will be obtained at designated time points during Part 2 for the assessment of nemtabrutinib Cmax (Day 1 of Cycles 1, 2, and 3: Pre-dose, 2, 4, 6, hours post-dose [up to ~57 days]). Each cycle is 28 days.
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Timepoint [10]
0
0
At designated time points (up to ~57 days)
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Secondary outcome [11]
0
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Part 2: DOR per iwCLL criteria 2018 as assessed by ICR
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Assessment method [11]
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For participants with CR, CRi, nPR, or PR per iwCLL 2018 criteria, DOR is defined as the time from the first documented evidence of objective response until disease progression or death due to any cause, whichever occurs first. CR is defined as meeting the following criteria: no lymph nodes >1.5 cm, spleen size <13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets =100 x 10^9/L; hemoglobin =11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as =50% decrease in =2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS =1 of the following met: platelets =100 x 10^9/L or =50% increase from screening, hemoglobin >11 g/dL or =50% increase from screening, CLL cells or B lymphoid nodules in marrow.
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Timepoint [11]
0
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Up to ~61 months
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Secondary outcome [12]
0
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Part 2: DOR per Lugano criteria 2014 as assessed by ICR
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Assessment method [12]
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For participants with CR or PR per Lugano criteria 2014, DOR is defined as the time from the first documented evidence of objective response until PD or death due to any cause, whichever occurs first. CR defined as EITHER CR by imaging (CT): all lymph nodes normal (none =15 mm) and normal liver and spleen OR CMR: score of 1, 2 or 3 on the 5-point scale assessing FDG metabolic activity in lymphomatous lesions (ranging from 1=no uptake above background to 5=uptake markedly higher than liver and/or new lesions) AND BM normal by morphology. PR defined as EITHER PR by imaging (CT) with =50% decrease in the SPD of target lesions, no worsening of nontarget lesions, no new lesions and =50% spleen abnormal portion OR PMR with score of 4 or 5 on the FDG 5-point scale (with no new lesions) and decreased overall uptake AND residual BM abnormalities; OR CR by imaging with residual BM abnormalities; OR PR by imaging without residual BM abnormalities.
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Timepoint [12]
0
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Up to ~61 months
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Secondary outcome [13]
0
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Part 2: DOR per IWWM criteria 2014 as assessed by ICR
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Assessment method [13]
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For participants with CR, VGPR, or PR per IWWM criteria 2014, DOR defined as the time from first documented evidence of objective response until PD or death due to any cause, whichever occurs first. CR defined as all lymph nodes normal in size (none =15 mm), liver and spleen normal in size, serum IgM values in normal range, disappearance of monoclonal protein by immunofixation (confirmation needed with second immunofixation at any subsequent timepoint), and no histological evidence of BM involvement. VGPR defined as =50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), =50% decrease from baseline in abnormal portion of the spleen (if previously abnormal), and =90% decrease from baseline in serum IgM, or serum IgM values in normal range. PR is defined as =50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), =50% decrease from baseline in serum IgM, and =50% decrease from baseline in abnormal portion of the spleen (if previously abnormal).
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Timepoint [13]
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Up to ~61 months
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Eligibility
Key inclusion criteria
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7
days prior to allocation
- Has a life expectancy of at least 3 months, based on the investigator assessment
- Has the ability to swallow and retain oral medication
- Participants who are Hepatitis B surface antigen (HBsAg)-positive are eligible if they
have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have
undetectable HBV viral load prior to randomization
- Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV
viral load is undetectable at screening
- Has adequate organ function
- Male participants agree to refrain from donating sperm and agree to either remain
abstinent from penile-vaginal intercourse as their preferred and usual lifestyle OR
agree to use contraception, during the intervention period and for at least the time
required to eliminate the study intervention after last dose of study intervention
- Female participants assigned female sex at birth who are not pregnant or breastfeeding
are eligible to participate if not a participant of childbearing potential (POCBP), or
if a POCBP they either use a contraceptive method that is highly effective OR remain
abstinent from penile-vaginal intercourse as their preferred and usual lifestyle
during the intervention period and for at least to eliminate study intervention after
the last dose of study intervention
- Participants with HIV are eligible if they meet all of the following: the CD4 count is
>350 cells/uL at screening, the HIV viral load is below the detectable level, are on a
stable ART regimen for at least 4 weeks prior to study entry, and are compliant with
their ART
Part 1 and Part 2 (Cohorts A to C and J)
- Has a confirmed diagnosis of CLL/SLL with
- At least 2 lines of prior therapy (Part 1 only)
- Part 2 Cohort A: CLL/SLL participants who are relapsed or refractory to prior
therapy with a covalent, irreversible Bruton's tyrosine kinase inhibitor (BTKi),
and a B-cell lymphoma 2 inhibitor (BCL2i). CLL participants must have received
and failed, been intolerant to, or determined by their treating physician to be a
poor phosphoinositide 3-kinase inhibitor (PI3Ki) candidate or ineligible for a
PI3Ki per local guidelines
- Part 2 Cohort B: CLL/SLL participants who are relapsed or refractory following at
least 1 line of prior therapy and are BTKi treatment naive
- Part 2 Cohort C: CLL/SLL participants with 17p deletion or tumor protein p53
(TP53) mutation who are relapsed or refractory following at least 1 line of prior
therapy
- Part 2 Cohort J: CLL/SLL participants whose disease relapsed or was refractory to
prior therapy with a covalent/irreversible BTKi and BCL2i
- Has active disease for CLL/SLL clearly documented to initiate therapy
- Has evaluable core or excisional lymph node biopsy for biomarker analysis from an
archival or newly obtained biopsy or bone marrow aspirate at Screening (optional
for participants enrolling in Part 1)
Part 2 (Cohorts D to G)
- Has a confirmed diagnosis of and meets the following prior therapy requirements:
- Participants with Richter's transformation who are relapsed or refractory
following at least 1 line of prior therapy (Cohort D)
- Participants with pathologically confirmed MCL, documented by either
overexpression of cyclin D1 or t(11;14), who are relapsed or are refractory to
chemoimmunotherapy and a covalent irreversible BTKi (Cohort E)
- Participants with MZL (including splenic, nodal, and extra nodal MZL) who are
relapsed or refractory to chemoimmunotherapy and a covalent irreversible BTKi
(Cohort F)
- Participants with FL who are relapsed or refractory to chemoimmunotherapy,
immunomodulatory agents (i.e. lenalidomide plus rituximab) (Cohort G)
- Have measurable disease defined as at least 1 lesion that can be accurately measured
in at least 2 dimensions with spiral CT scan
- Has a lymph node biopsy for biomarker analysis from an archival or newly obtained
biopsy or bone marrow aspirate (Cohort D) at Screening
Part 2 (Cohort H): confirmed diagnosis of WM; participants who are relapsed or refractory
to standard therapies for WM including chemoimmunotherapy and a covalent irreversible BTKi
- Has active disease defined as 1 of the following: systemic symptoms, physical
findings, laboratory abnormalities, coexisting disease
- Has measurable disease, satisfying any of the following: at least 1 lesion that can be
accurately measured in at least 2 dimensions with spiral CT scan (minimum measurement
must be >15 mm in the longest diameter or >10 mm in the short axis); IgM =450 mg/dL;
or bone marrow infiltration of 10%
- Has fresh bone marrow aspirate or a lymph node biopsy for biomarker analysis at
Screening or a lymph node biopsy from an archival
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Has active HBV/HCV infection (Part 1 and Part 2)
- Has a history of malignancy =3 years before providing documented informed consent.
Participants with basal cell carcinoma of skin, squamous cell carcinoma of skin, or
carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone
potential curative therapy are not excluded. Participants with low-risk, early-stage
prostate cancer (T1-T2a, Gleason score =6, and prostate-specific antigen <10 ng/mL)
either treated with definitive intent or untreated in active surveillance with SD are
not excluded
- Has active central nervous system (CNS) disease
- Has an active infection requiring systemic therapy
- Has received prior systemic anti-cancer therapy within 4 weeks prior to allocation
- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks prior to the first dose of
study intervention
- Has any clinically significant gastrointestinal abnormalities that might alter
absorption
- History of severe bleeding disorders
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/04/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
19/03/2027
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Actual
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Sample size
Target
490
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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0
Nepean Hospital-Nepean Cancer Care Centre ( Site 0204) - Sydney
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Recruitment hospital [2]
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Box Hill Hospital ( Site 0203) - Box Hill
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Recruitment hospital [3]
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Sir Charles Gairdner Hospital ( Site 0200) - Nedlands
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Recruitment postcode(s) [1]
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0
2747 - Sydney
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Recruitment postcode(s) [2]
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0
3128 - Box Hill
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arkansas
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Colorado
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Kentucky
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Minnesota
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Country [6]
0
0
United States of America
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State/province [6]
0
0
New Jersey
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Country [7]
0
0
United States of America
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State/province [7]
0
0
North Dakota
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Texas
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Washington
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Country [10]
0
0
Argentina
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State/province [10]
0
0
Buenos Aires
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Country [11]
0
0
Argentina
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State/province [11]
0
0
Caba
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Country [12]
0
0
Argentina
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State/province [12]
0
0
Santa Fe
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Country [13]
0
0
Argentina
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State/province [13]
0
0
Cordoba
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Country [14]
0
0
Argentina
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State/province [14]
0
0
Mendoza
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Country [15]
0
0
Brazil
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State/province [15]
0
0
Sao Paulo
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Country [16]
0
0
Brazil
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State/province [16]
0
0
Rio de Janeiro
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Country [17]
0
0
Canada
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State/province [17]
0
0
Alberta
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Country [18]
0
0
Canada
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State/province [18]
0
0
Ontario
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Country [19]
0
0
Canada
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State/province [19]
0
0
Quebec
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Country [20]
0
0
China
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State/province [20]
0
0
Anhui
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Country [21]
0
0
China
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State/province [21]
0
0
Beijing
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Country [22]
0
0
China
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State/province [22]
0
0
Chongqing
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Country [23]
0
0
China
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State/province [23]
0
0
Guangdong
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Country [24]
0
0
China
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State/province [24]
0
0
Guangxi
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Country [25]
0
0
China
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State/province [25]
0
0
Henan
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Country [26]
0
0
China
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State/province [26]
0
0
Hubei
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Country [27]
0
0
China
Query!
State/province [27]
0
0
Hunan
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Jiangsu
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Country [29]
0
0
China
Query!
State/province [29]
0
0
Jiangxi
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Jilin
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Shanghai
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Country [32]
0
0
China
Query!
State/province [32]
0
0
Sichuan
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Country [33]
0
0
China
Query!
State/province [33]
0
0
Tianjin
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Country [34]
0
0
China
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State/province [34]
0
0
Zhejiang
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Country [35]
0
0
Czechia
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State/province [35]
0
0
Brno-mesto
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Country [36]
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0
Czechia
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State/province [36]
0
0
Hradec Kralove
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Country [37]
0
0
Denmark
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State/province [37]
0
0
Midtjylland
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Country [38]
0
0
Denmark
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State/province [38]
0
0
Nordjylland
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Country [39]
0
0
Denmark
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State/province [39]
0
0
Sjaelland
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Country [40]
0
0
Denmark
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State/province [40]
0
0
Syddanmark
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Country [41]
0
0
France
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State/province [41]
0
0
Alpes-Maritimes
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Country [42]
0
0
France
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State/province [42]
0
0
Bouches-du-Rhone
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Country [43]
0
0
France
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State/province [43]
0
0
Rhone-Alpes
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Country [44]
0
0
France
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State/province [44]
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0
Yvelines
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Country [45]
0
0
France
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State/province [45]
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0
Paris
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Country [46]
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0
Germany
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State/province [46]
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0
Baden-Wurttemberg
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Country [47]
0
0
Germany
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State/province [47]
0
0
Nordrhein-Westfalen
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Country [48]
0
0
Germany
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State/province [48]
0
0
Sachsen
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Country [49]
0
0
Hungary
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State/province [49]
0
0
Baranya
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Country [50]
0
0
Hungary
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State/province [50]
0
0
Hajdu-Bihar
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Country [51]
0
0
Hungary
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State/province [51]
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0
Szabolcs-Szatmar-Bereg
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Country [52]
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0
Hungary
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0
Budapest
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Country [53]
0
0
Ireland
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0
0
Dublin
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Country [54]
0
0
Ireland
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State/province [54]
0
0
Limerick
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Country [55]
0
0
Israel
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State/province [55]
0
0
Afula
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Country [56]
0
0
Israel
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State/province [56]
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0
Beer-Sheva
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Country [57]
0
0
Israel
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State/province [57]
0
0
Haifa
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Country [58]
0
0
Israel
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State/province [58]
0
0
Jerusalem
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Country [59]
0
0
Israel
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State/province [59]
0
0
Ramat Gan
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Country [60]
0
0
Israel
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State/province [60]
0
0
Rehovot
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Country [61]
0
0
Israel
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State/province [61]
0
0
Tel Aviv
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Country [62]
0
0
Italy
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State/province [62]
0
0
Bari
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Country [63]
0
0
Italy
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State/province [63]
0
0
Bologna
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Country [64]
0
0
Italy
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State/province [64]
0
0
Brescia
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Country [65]
0
0
Italy
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State/province [65]
0
0
Milano
Query!
Country [66]
0
0
Italy
Query!
State/province [66]
0
0
Napoli
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Country [67]
0
0
Italy
Query!
State/province [67]
0
0
Pavia
Query!
Country [68]
0
0
Italy
Query!
State/province [68]
0
0
Reggio Emilia
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Country [69]
0
0
Italy
Query!
State/province [69]
0
0
Roma
Query!
Country [70]
0
0
Korea, Republic of
Query!
State/province [70]
0
0
Seoul
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Dolnoslaskie
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Country [72]
0
0
Poland
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State/province [72]
0
0
Malopolskie
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Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Mazowieckie
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Country [74]
0
0
Poland
Query!
State/province [74]
0
0
Opolskie
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Country [75]
0
0
Poland
Query!
State/province [75]
0
0
Pomorskie
Query!
Country [76]
0
0
Romania
Query!
State/province [76]
0
0
Bucuresti
Query!
Country [77]
0
0
Romania
Query!
State/province [77]
0
0
Constanta
Query!
Country [78]
0
0
Romania
Query!
State/province [78]
0
0
Brasov
Query!
Country [79]
0
0
Romania
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State/province [79]
0
0
Iasi
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Country [80]
0
0
Spain
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State/province [80]
0
0
Barcelona
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Country [81]
0
0
Spain
Query!
State/province [81]
0
0
La Coruna
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Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Alicante
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Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Madrid
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Country [84]
0
0
Spain
Query!
State/province [84]
0
0
Salamanca
Query!
Country [85]
0
0
Switzerland
Query!
State/province [85]
0
0
Berne
Query!
Country [86]
0
0
Switzerland
Query!
State/province [86]
0
0
Ticino
Query!
Country [87]
0
0
Turkey
Query!
State/province [87]
0
0
Istanbul
Query!
Country [88]
0
0
Turkey
Query!
State/province [88]
0
0
Ankara
Query!
Country [89]
0
0
Turkey
Query!
State/province [89]
0
0
Izmir
Query!
Country [90]
0
0
Ukraine
Query!
State/province [90]
0
0
Cherkaska Oblast
Query!
Country [91]
0
0
Ukraine
Query!
State/province [91]
0
0
Ivano-Frankivska Oblast
Query!
Country [92]
0
0
Ukraine
Query!
State/province [92]
0
0
Lvivska Oblast
Query!
Country [93]
0
0
Ukraine
Query!
State/province [93]
0
0
Kyiv
Query!
Country [94]
0
0
United Kingdom
Query!
State/province [94]
0
0
Bristol, City Of
Query!
Country [95]
0
0
United Kingdom
Query!
State/province [95]
0
0
England
Query!
Country [96]
0
0
United Kingdom
Query!
State/province [96]
0
0
London, City Of
Query!
Country [97]
0
0
United Kingdom
Query!
State/province [97]
0
0
Oxfordshire
Query!
Country [98]
0
0
United Kingdom
Query!
State/province [98]
0
0
Suffolk
Query!
Country [99]
0
0
United Kingdom
Query!
State/province [99]
0
0
Surrey
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Country [100]
0
0
United Kingdom
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State/province [100]
0
0
Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly
ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/
small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL),
mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia
(WM).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04728893
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Medical Director
Query!
Address
0
0
Merck Sharp & Dohme LLC
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Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Toll Free Number
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-888-577-8839
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Fax
0
0
Query!
Email
0
0
[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04728893
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