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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/NCT04912063
Registration number
NCT04912063
Ethics application status
Date submitted
28/05/2021
Date registered
3/06/2021
Date last updated
26/02/2024
Titles & IDs
Public title
Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome
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Scientific title
A Phase 1b Dose Escalation Study of Lemzoparlimab in Combination With Venetoclax and/or Azacitidine in Subjects With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
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Secondary ID [1]
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2021-000514-41
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Secondary ID [2]
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M20-866
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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:
Acute Myeloid Leukemia (AML)
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Myelodysplastic Syndrome (MDS)
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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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Blood
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Haematological diseases
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Blood
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Other blood disorders
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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 - Lemzoparlimab
Treatment: Drugs - Azacitidine
Treatment: Drugs - Venetoclax
Experimental: Lemzoparlimab + Azacitidine + Venetoclax in AML (Escalation) - Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in escalated doses in participants with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.
Experimental: Lemzoparlimab + Azacitidine + Venetoclax in MDS (Escalation) - Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in escalated doses in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).
Experimental: Lemzoparlimab + Azacitidine in MDS (Escalation) - Lemzoparlimab (TJ011133) co-administered with azacitidine in escalated doses in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).
Experimental: Lemzoparlimab + Azacitidine + Venetoclax in AML (Expansion) - Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in expansion cohort in participants with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.
Experimental: Lemzoparlimab + Azacitidine + Venetoclax in MDS (Expansion) - Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in expansion cohort in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).
Experimental: Lemzoparlimab Monotherapy in AML (Japan Only Escalation) - Lemzoparlimab (TJ011133) administered in escalated doses in participants with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.
Experimental: Lemzoparlimab Monotherapy in MDS (Japan Only Escalation) - Lemzoparlimab (TJ011133) administered in escalated doses in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).
Treatment: Drugs: Lemzoparlimab
Intravenous (IV) Infusion
Treatment: Drugs: Azacitidine
Subcutaneous Injection or Intravenous (IV) Injection/Infusion
Treatment: Drugs: Venetoclax
Oral Tablet
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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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Dose Limiting Toxicities (DLTs) of Lemzoparlimab (TJ011133) When Co-administered With Venetoclax and Azacitidine in Participants With Treatment-Naïve Acute Myeloid Leukemia (AML) Ineligible for Standard Induction Therapy
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Assessment method [1]
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DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications and occurring during the first 4 weeks after administration of the first dose and that meets additional criteria as described in the protocol.
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Timepoint [1]
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Up to 30 days after first dose of study drug
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Primary outcome [2]
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DLTs of Lemzoparlimab (TJ011133) When Co-administered With Azacitidine With or Without Venetoclax in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndrome (MDS)
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Assessment method [2]
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DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications and occurring during the first 4 weeks after administration of the first dose and that meets additional criteria as described in the protocol.
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Timepoint [2]
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Up to 30 days after first dose of study drug
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Primary outcome [3]
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Dose Limiting Toxicities (DLTs) of Lemzoparlimab (TJ011133) as a Monotherapy in Japanese Participants with Relapsed/Refractory (R/R) AML
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Assessment method [3]
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DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications and occurring during the first 4 weeks after administration of the first dose and that meets additional criteria as described in the protocol.
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Timepoint [3]
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Up to 30 days after first dose of study drug
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Primary outcome [4]
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DLTs of Lemzoparlimab (TJ011133) as a Monotherapy in Japanese Participants with R/R MDS
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Assessment method [4]
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DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications and occurring during the first 4 weeks after administration of the first dose and that meets additional criteria as described in the protocol.
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Timepoint [4]
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Up to 30 days after first dose of study drug
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Secondary outcome [1]
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Best Overall Response of Complete Remission (CR) for AML
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Assessment method [1]
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Best overall response of complete remission (CR), defined as achieving CR according to modified international working group (IWG) 2003 criteria for AML.
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Timepoint [1]
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Up to approximately 3 years
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Secondary outcome [2]
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Best Overall Response of Composite CR (CRc) for AML
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Assessment method [2]
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Best overall response of composite CR (CRc), [CR or CR with incomplete blood count recovery (CRi)] according to modified IWG 2003 criteria for AML.
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Timepoint [2]
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Up to approximately 3 years
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Secondary outcome [3]
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Best Overall Response of CR or Complete Remission With Partial Hematologic Recovery (CRh) for AML
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Assessment method [3]
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Best overall response of CR or CRh, defined according to modified IWG 2003 criteria for AML.
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Timepoint [3]
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Up to approximately 3 years
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Secondary outcome [4]
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Duration of Response (DOR) for AML
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Assessment method [4]
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Duration of response (DOR), defined for participants who achieve a best overall response, as the time from the first occurrence of response to disease progression/relapse from CR, CRi or CRh or death from disease progression, whichever occurs first.
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Timepoint [4]
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Up to approximately 3 years
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Secondary outcome [5]
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Event-Free Survival (EFS) for AML
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Assessment method [5]
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Event-free survival (EFS), defined as time from first dose of any study drug (lemzoparlimab or venetoclax or azacitidine) to the date of progressive disease (PD), relapse from CR or CRi, treatment failure defined as failure to achieve CR, CRi or MLFS after at least 6 cycles of study treatment, or death from any cause, whichever occurs first.
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Timepoint [5]
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Up to approximately 3 years
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Secondary outcome [6]
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Overall Survival (OS ) for AML
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Assessment method [6]
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Overall survival (OS), defined as the time from the date of the first dose of any study drug (lemzoparlimab or venetoclax or azacitidine) to death from any cause.
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Timepoint [6]
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Up to approximately 3 years
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Secondary outcome [7]
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Best Overall Response of CR, for MDS
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Assessment method [7]
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Best overall response of CR per the modified IWG 2006 criteria for MDS.
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Timepoint [7]
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Up to approximately 3 years
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Secondary outcome [8]
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Best Overall Response of Marrow-Complete Remission (mCR), for MDS
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Assessment method [8]
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Best overall response of marrow-complete remission (mCR), per the modified IWG 2006 criteria for MDS.
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Timepoint [8]
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Up to approximately 3 years
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Secondary outcome [9]
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Best Overall Response of CR or PR for MDS
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Assessment method [9]
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Best overall response of CR or PR, per the modified IWG 2006 criteria for MDS.
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Timepoint [9]
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Up to approximately 3 years
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Secondary outcome [10]
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Best Overall Response of CR or PR or mCR, for MDS
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Assessment method [10]
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Best overall response of CR or PR or mCR, per the modified IWG 2006 criteria for MDS.
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Timepoint [10]
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Up to approximately 3 years
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Secondary outcome [11]
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Hematologic Improvement (HI), for MDS
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Assessment method [11]
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Hematologic improvement (HI), defined as a participant achieving erythroid/platelet/neutrophil responses.
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Timepoint [11]
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Up to approximately 3 years
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Secondary outcome [12]
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Red Blood Cell Transfusion Independence (TI), for MDS
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Assessment method [12]
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Red blood cell transfusion independence (TI), defined as a participant who is transfusion dependent at baseline achieved TI post-baseline.
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Timepoint [12]
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Up to approximately 3 years
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Secondary outcome [13]
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Platelet TI, for MDS
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Assessment method [13]
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Platelet TI, defined as a participant who is transfusion dependent at baseline achieved TI post-baseline.
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Timepoint [13]
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Up to approximately 3 years
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Secondary outcome [14]
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DOR, for MDS
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Assessment method [14]
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DOR, defined for participants who achieve a best overall response, as the time from the first occurrence of response (CR or mCR or PR) to disease progression or death, whichever occurs first.
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Timepoint [14]
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Up to approximately 3 years
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Secondary outcome [15]
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Progression Free Survival (PFS), for MDS
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Assessment method [15]
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Progression Free Survival (PFS) defined as the time from the date of the first dose of any study drug to PD or death from any cause.
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Timepoint [15]
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Up to approximately 3 years
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Secondary outcome [16]
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OS, for MDS
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Assessment method [16]
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OS, defined as the time from the date of the first dose of any study drug to death from any cause.
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Timepoint [16]
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Up to approximately 3 years
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Eligibility
Key inclusion criteria
- Documented confirmation of acute myeloid leukemia (AML) according to the World Health
Organization (WHO) criteria, previously untreated [OR]
- Documented diagnosis of previously untreated de novo myelodysplastic syndrome (MDS)
according to the 2017 WHO classification with presence of < 20% bone marrow blasts per
marrow biopsy/aspirate.
- Participants with documented MDS must meet the following disease activity criteria:
- Overall revised international prognostic scoring system (IPSS-R) score > 3
(intermediate, high, or very high);
- Eastern cooperative oncology group (ECOG) performance status of 0 to 2;
- Hematopoietic stem cell transplant (HSCT) ineligible, or participant who chooses
not to undergo HSCT.
- Participants with documented AML with adverse cytogenetic and/or molecular risk, and
must be considered ineligible for induction therapy defined by the following:
- >= 75 years of age; [OR]
- >= 18 to 74 years of age with at least one of the following comorbidities: ---
Eastern cooperative oncology group (ECOG) performance status of 2 to 3; ---
Cardiac history of congestive heart failure requiring treatment or ejection
fraction <= 50% or chronic stable angina;
- Diffusion capacity of lung (DLCO) <= 65% or forced expiratory volume during
the first second (FEV1) <= 65%;
- Creatinine clearance >= 30 mL/min to < 45 mL/min;
- Moderate hepatic impairment with total bilirubin > 1.5 to <= 3.0 × upper
limit of normal (ULN);
- Any other comorbidity that the physician judges to be incompatible with
intensive chemotherapy or the participant declines to receive intensive
chemotherapy.
Japan Safety Lead-In Phase:
- Documented confirmation of AML according to WHO criteria, relapsed or refractory (R/R)
disease without other standard of care treatments.
- Documented diagnosis of MDS according to the 2017 WHO classification with presence of
< 20% bone marrow blasts per marrow biopsy/aspirate, with intermediate- and high-risk
relapsed/refractory MDS.
- Documented MDS must meet the following disease activity criteria:
- ECOG performance status of 0 to 2.
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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
- Participants with documented AML with acute promyelocytic leukemia and considered
eligible for induction therapy.
- Participant with documented AML having prior diagnosis of:
-- known active central nervous system involvement with AML.
- Participants with documented MDS having prior diagnosis of:
- MDS evolving from a pre-existing myeloproliferative neoplasm (MPN);
- MDS/MPN including chronic myelomonocytic leukemia, atypical chronic myeloid
leukemia, juvenile myelomonocytic leukemia and unclassifiable MDS/MPN.
- History of allogeneic HSCT or solid organ transplantation.
- Previous exposure to anti-CD47 therapies.
- History of an active malignancy within the past 2 years prior to Screening, with the
exception of:
-- Adequately treated carcinoma in situ of the cervix uteri or carcinoma in situ of
the breast;
- Adequately treated basal cell carcinoma or localized squamous cell carcinoma of
the skin;
- Asymptomatic prostate cancer without known metastatic disease and with no
requirement for therapy;
- Previous malignancy confined and surgically resected (or treated with other
modalities) with curative intent.
- Conditions that could interfere with drug absorption including but not limited to
short bowel syndrome.
Japan Safety Lead-In Phase:
- Documented AML have Acute Promyelocytic Leukemia.
- Participant with documented AML having prior diagnosis of:
-- Chronic myeloid leukemia with or without BCR-ABL1 translocation and AML with
BCR-ABL1 translocation.
- Participants with documented MDS having prior diagnosis of:
- Therapy-related MDS.
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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
Terminated
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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
25/06/2021
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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
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Actual
9/05/2023
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Sample size
Target
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Liverpool Hospital /ID# 227723 - Liverpool
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Recruitment hospital [2]
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Austin Health /ID# 227717 - Heidelberg
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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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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Kentucky
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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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Michigan
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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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Pennsylvania
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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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Texas
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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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Virginia
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Country [8]
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Germany
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State/province [8]
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Nordrhein-Westfalen
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Country [9]
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Germany
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State/province [9]
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Sachsen
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Country [10]
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Germany
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State/province [10]
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Dresden
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Country [11]
0
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Germany
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State/province [11]
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Hamburg
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Country [12]
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Israel
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State/province [12]
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Tel-Aviv
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Country [13]
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Israel
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State/province [13]
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Yerushalayim
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Country [14]
0
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Israel
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State/province [14]
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Petakh Tikva
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Country [15]
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Italy
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State/province [15]
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Milano
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Country [16]
0
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Italy
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State/province [16]
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Bologna
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Country [17]
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Japan
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State/province [17]
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Chiba
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Country [18]
0
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Japan
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State/province [18]
0
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Fukui
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Country [19]
0
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Japan
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State/province [19]
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Fukuoka
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Country [20]
0
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Japan
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State/province [20]
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Yamagata
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Country [21]
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Spain
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State/province [21]
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Barcelona
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Country [22]
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Spain
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State/province [22]
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Madrid
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Country [23]
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Spain
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State/province [23]
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Malaga
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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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
Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low
survival rate and few options for participants who are unable to undergo intensive
chemotherapy, the current standard of care. This study is to evaluate how safe lemzoparlimab
is and how it moves within the body when used along with azacitidine and/or venetoclax in
adult participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Adverse events and maximum tolerated dose (MTD) of lemzoparlimab will be assessed.
Lemzoparlimab (TJ011133) is being evaluated in combination with azacitidine and venetoclax
for the treatment of acute myeloid leukemia (AML) and with azacitidine with/without
venetoclax for myelodysplastic syndrome (MDS). Study doctors place the participants in 1 of 5
groups, called treatment arms. Each group receives a different treatment. Adult participants
with a diagnosis of AML or MDS will be enrolled. Around 80 participants will be enrolled in
the study in approximately 50 sites worldwide.
Participants will receive lemzoparlimab (IV) once weekly (Q1W), venetoclax oral tablets once
daily (QD) for 28 days (AML participants) or 14 days (MDS participants) and Azacitidine by SC
or IV route QD for 7 days of each 28-day cycle.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, blood tests and
checking for side effects.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04912063
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Country
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04912063
Download to PDF