A Study of JNJ-75276617 in Participants With Acute Leukemia
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|ClinicalTrials.gov Identifier: NCT04811560|
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : September 9, 2022
|Condition or disease||Intervention/treatment||Phase|
|Acute Leukemias Acute Myeloid Leukemia Acute Lymphoblastic Leukemia||Drug: JNJ-75276617||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A First in Human Study of the Menin-KMT2A (MLL1) Inhibitor JNJ-75276617 in Participants With Acute Leukemia|
|Actual Study Start Date :||May 19, 2021|
|Estimated Primary Completion Date :||December 26, 2023|
|Estimated Study Completion Date :||June 20, 2025|
Participants in Part 1 (dose escalation) will receive JNJ-75276617 orally on a 28-day cycle. The 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 Part 2 (dose expansion) will receive JNJ-75276617 orally at one of the RP2D(s) determined in Part 1. Food effect cohort (optional) participants will receive JNJ-75276617 orally on Cycle 2 Day 1 under fasted condition and on Cycle 2 Day 2 under fed condition.
JNJ-75276617 is administered orally.
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 2 years and 10 months ]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.
- Number of Participants with AEs by Severity [ Time Frame: Up to 2 years and 10 months ]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.
- Part 1: Percentage of Participants with Dose-Limiting Toxicity (DLT) [ Time Frame: Up to 28 days Cycle 1 ]Percentage of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
- Plasma Concentration of JNJ-75276617 [ Time Frame: Up to 2 years and 10 months ]Plasma concentration of JNJ-75276617 will be reported.
- Number of Participants with Depletion of Leukemic Blasts [ Time Frame: Up to 2 years and 10 months ]Number of participants with depletion of leukemic blasts will be reported.
- Number of Participants with Differentiation of Leukemic Blasts [ Time Frame: Up to 2 years and 10 months ]Number of participants with differentiation of leukemic blasts will be reported.
- Changes in Expression of Menin-histone-lysine N-methyltransferase 2A (KMT2A) Target Genes [ Time Frame: Up to 2 years and 10 months ]Changes in expression of menin-KMT2A target genes will be reported.
- Overall Response Rate (ORR) [ Time Frame: Up to 2 years and 10 months ]ORR is defined as the percentage of participants who achieve complete remission (CR), CR with incomplete hematologic recovery (CRi) and CR with partial hematologic recovery (CRh).
- Duration of Response (DOR) [ Time Frame: Up to 2 years and 10 months ]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.
- Time to Response (TTR) [ Time Frame: Up to 2 years and 10 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04811560
|Contact: Study Contact||844-434-4210||Participate-In-This-Study@its.jnj.com|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|