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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/NCT05521087
Registration number
NCT05521087
Ethics application status
Date submitted
29/08/2022
Date registered
30/08/2022
Date last updated
9/11/2023
Titles & IDs
Public title
A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias
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Scientific title
A Phase I/Ib Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleoporin Gene Alterations
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Secondary ID [1]
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2022-000380-46
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Secondary ID [2]
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CR109192
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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:
Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JNJ-75276617
Treatment: Drugs - Fludarabine
Treatment: Drugs - Cytarabine
Treatment: Drugs - Intrathecal Chemotherapy
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Vincristine
Treatment: Drugs - Pegaspargase
Experimental: Arm A: <2 Years Old - Participants aged less than (<) 2 years old in dose escalation portion of the study will receive JNJ-75276617 orally on a 28-day cycle. Starting dose of JNJ-75276617 is based on the adult dose from the ongoing study NCT04811560 with additional dose reductions based on age. Further dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by study evaluation team (SET) until the recommended Phase 2 Doses (RP2Ds) has been identified. Participants in dose expansion portion of the study will receive JNJ-75276617 orally at one of the RP2D(s) determined in dose escalation portion of the study, in 3 cohorts divided on the basis of disease diagnosis. Participants with acute myeloid leukemia (AML) and B-cell acute lymphoblastic leukemia (ALL) will receive conventional chemotherapy backbone regimen (dexamethasone, vincristine, pegaspargase, fludarabine, cytarabine and intrathecal chemotherapy) in combination with JNJ-75276617.
Experimental: Arm B: >=2 Years Old - Participants aged greater than or equal to (>=) 2 years old in dose escalation portion of the study will receive JNJ-75276617 orally on a 28-day cycle. Starting dose of JNJ-75276617 is based on the adult dose from the ongoing study NCT04811560 with additional dose reductions based on age. Further dose levels will be escalated based on the DLT evaluation by SET until the RP2Ds has been identified. Participants in dose expansion portion of the study will receive JNJ-75276617 orally at one of the RP2D(s) determined in dose escalation portion, in 3 cohorts divided on the basis of disease diagnosis. Participants with AML and B-cell ALL will receive conventional chemotherapy backbone regimen (dexamethasone, vincristine, pegaspargase, fludarabine, cytarabine and intrathecal chemotherapy) in combination with JNJ-75276617.
Treatment: Drugs: JNJ-75276617
JNJ-75276617 will be administered orally.
Treatment: Drugs: Fludarabine
Fludarabine chemotherapy will be administered as intravenous (IV) infusion for participants with AML.
Treatment: Drugs: Cytarabine
Cytarabine chemotherapy will be administered as IV infusion for participants with AML.
Treatment: Drugs: Intrathecal Chemotherapy
Intrathecal chemotherapy will be administered as IV infusion for participants with AML or B-cell ALL.
Treatment: Drugs: Dexamethasone
Dexamethasone chemotherapy will be administered as IV infusion for participants with B-cell ALL.
Treatment: Drugs: Vincristine
Vincristine chemotherapy will be administered as IV infusion for participants with B-cell ALL.
Treatment: Drugs: Pegaspargase
Pegaspargase chemotherapy will be administered as IV infusion for participants with B-cell ALL.
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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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Number of Participants with Adverse Events (AEs)
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Assessment method [1]
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
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Timepoint [1]
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Up to 3 years 5 months
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Primary outcome [2]
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Number of Participants with AEs by Severity
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Assessment method [2]
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
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Timepoint [2]
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Up to 3 years 5 months
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Primary outcome [3]
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Number of Participants with Dose-Limiting Toxicity (DLT)
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Assessment method [3]
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Percentage of participants with DLT will be assessed. The DLTs are specific adverse events related to JNJ-75276617 and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
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Timepoint [3]
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Cycle 1 (28 days)
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Secondary outcome [1]
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Plasma Concentration of JNJ-75276617
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Assessment method [1]
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Plasma concentration of JNJ-75276617 will be reported.
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Timepoint [1]
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Up to 3 years 5 months
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Secondary outcome [2]
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Number of Participants with Depletion of Leukemic Blasts
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Assessment method [2]
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Number of participants with depletion of leukemic blasts will be reported.
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Timepoint [2]
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Up to 3 years 5 months
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Secondary outcome [3]
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Number of Participants with Differentiation of Leukemic Blasts
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Assessment method [3]
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Number of participants with differentiation of leukemic blasts will be reported.
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Timepoint [3]
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Up to 3 years 5 months
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Secondary outcome [4]
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Changes in Expression of Menin-histone-lysine N-methyltransferase 2A (KMT2A) Target Genes or Genes Associated With Differentiation
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Assessment method [4]
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Changes in expression of menin-histone-lysine N-methyltransferase 2A (KMT2A) target genes or genes associated with differentiation will be reported.
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Timepoint [4]
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Up to 3 years 5 months
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Secondary outcome [5]
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Overall Response Rate (ORR) per Response Criteria in Acute Myeloid Leukemia (AML)
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Assessment method [5]
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ORR is defined as the percentage of participants who achieve complete response (CR), CR with incomplete hematologic recovery (CRi) or CR with partial hematologic recovery (CRh) per the Response Criteria in AML.
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Timepoint [5]
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Up to 3 years 5 months
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Secondary outcome [6]
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Overall Response Rate (ORR) per the Response Criteria in B-cell Acute Lymphoblastic Leukemia (ALL)
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Assessment method [6]
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ORR in participants with B-cell ALL is defined as the percentage of participants who achieve CR or CRi per the response criteria in B-cell ALL.
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Timepoint [6]
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Up to 3 years 5 months
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Secondary outcome [7]
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Time to Response (TTR)
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Assessment method [7]
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TTR is defined for the responders as the time from the date of the first dose of JNJ-75276617 to the date of the first documented response.
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Timepoint [7]
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Up to 3 years 5 months
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Secondary outcome [8]
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Duration of Response (DOR)
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Assessment method [8]
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DOR will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of relapse, as defined in the disease-specific response criteria, or death due to any cause, whichever occurs first.
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Timepoint [8]
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Up to 3 years 5 months
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Secondary outcome [9]
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Percentage of Participants With Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
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Assessment method [9]
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Percentage of participants who receive an allogeneic HSCT after treatment will be reported.
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Timepoint [9]
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Up to 3 years 5 months
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Eligibility
Key inclusion criteria
- Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A) or
nucleophosmin 1 gene (NPM1) or nucleoporin (NUP98 or NUP214) alterations
- Performance status greater than or equal to (>=) 50 by lansky scale (for participants
less than [<] 16 years of age) or >=50 percent (%) karnofsky scale (for participants
>=16 years of age)
- Estimated or measured glomerular filtration rate >= 60 milliliter per minute per 1.73
meter square (mL/min/1.73m^2) based on the bed side schwartz formula
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Minimum age
30
Days
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Maximum age
30
Years
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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
- Received an allogeneic hematopoietic transplant within 60 days of screening
- Active acute graft-versus-host disease of any grade or chronic graft-versus-host which
is not well-controlled
- Received immunosuppressive therapy post hematopoietic transplant within 30 days of
enrollment
- Diagnosis of Down syndrome associated leukemia, acute promyelocytic leukemia, juvenile
myelomonocytic leukemia
- Diagnosis of fanconi anemia, kostmann syndrome, shwachman diamond syndrome, or any
other known bone marrow failure syndrome
- Prior exposure to menin-KMT2A inhibitors
- Prior cancer immunotherapy (ie [that is], Chimeric Antigen Receptor-T Cell Therapy
[CAR-T], inotuzumab, gemtuzumab ozogamicin) within 4 weeks prior to enrollment or
blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies
must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent
(whichever is shorter)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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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
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet 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
7/02/2024
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Actual
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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
11/09/2026
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Actual
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Sample size
Target
80
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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North Carolina
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Country [6]
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United States of America
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State/province [6]
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Ohio
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Country [7]
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United States of America
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State/province [7]
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Tennessee
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Country [8]
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United States of America
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Texas
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Country [9]
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United States of America
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State/province [9]
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Utah
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Country [10]
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United States of America
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Wisconsin
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Country [11]
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France
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State/province [11]
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Lille
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Country [12]
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France
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State/province [12]
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Lyon Cedex 08
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Country [13]
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France
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State/province [13]
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Paris
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Country [14]
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France
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State/province [14]
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Rennes Cedex 2
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France
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State/province [15]
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Toulouse
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Country [16]
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France
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State/province [16]
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Vandœuvre-lès-Nancy
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Germany
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Berlin
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Germany
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State/province [18]
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Essen
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Germany
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State/province [19]
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Hamburg
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Germany
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Hannover
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Germany
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State/province [21]
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Munchen
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Spain
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State/province [22]
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Barcelona
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Spain
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State/province [23]
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Madrid
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Country [24]
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Spain
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State/province [24]
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Zaragoza
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United Kingdom
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State/province [25]
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Birmingham
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Country [26]
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United Kingdom
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State/province [26]
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Glasgow
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Country [27]
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United Kingdom
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State/province [27]
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London
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Country [28]
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United Kingdom
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State/province [28]
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, 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 determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 ([KMT2A1], nucleophosmin 1 gene (NPM1), or nucleoporin alterations in Part 1 (Dose Escalation) and to further evaluate safety at the RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 (Dose Expansion).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05521087
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Contact
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Address
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Country
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Phone
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844-434-4210
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/ct2/show/NCT05521087
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