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 : May 31, 2023
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|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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Relapsed or refractory acute leukemia and has exhausted, or is ineligible for, available therapeutic options
- Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A) or nucleophosmin 1 gene (NPM1) alterations
- Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count less than or equal to (<=) 30 * 10^9/liter (L) (hydroxyurea may be used to lower WBC count at screening and during study; (b) Chemistry: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 * upper limit of normal (ULN), total serum bilirubin <= 1.5 * ULN (participants with elevated bilirubinemia, such as Gilbert's syndrome, may enroll if conjugated bilirubin is within clinically acceptable range) and renal function; Estimated or measured glomerular filtration rate greater than or equal to (>=) 60 milliliter per minute (mL/min)/1.73 meter square (m^2) per four variable modified diet in renal disease (MDRD) equation
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1, or 2
- A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
- A male must agree to all the following during the study and for 90 days after the last dose of study treatment: A male must agree to all the following during the study and for 90 days after the last dose of study treatment: (a) wear a condom when engaging in any activity that allows for passage of ejaculate to another person; (b) not to donate sperm or freeze for future use for the purpose of reproduction. In addition, the participant should be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak
- Acute promyelocytic leukemia according to World Health Organization (WHO) 2016 criteria
- Active central nervous system (CNS) disease
- Prior solid organ transplantation
- QTc according to Fridericia's formula (QTcF) for males >= 450 millisecond (msec) or for females >= 470 msec. Participants with a family history of Long QT syndrome are excluded
- Exclusion criteria related to stem cell transplant: a. Willing and able to undergo allogeneic stem cell transplant (if clinically indicated); b. Received prior treatment with allogenic bone marrow or stem cell transplant <=3 months before the first dose of study treatment; c. Has evidence of graft versus host disease; d. Received donor lymphocyte infusion <=1 month before the first dose of study treatment; e. Requires immunosuppressant therapy (exception: daily doses <=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement)
- Chemotherapy, targeted therapy, immunotherapy, or radiotherapy within 4 weeks or 5 half-lives (whichever is shorter) before the planned first dose of study treatment
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|
|Responsible Party:||Janssen Research & Development, LLC|
|Other Study ID Numbers:||
2020-005967-30 ( EudraCT Number )
75276617ALE1001 ( Other Identifier: Janssen Research & Development, LLC )
|First Posted:||March 23, 2021 Key Record Dates|
|Last Update Posted:||May 31, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immune System Diseases