A Study of JNJ-75276617 in Participants with Acute Leukemia

JRCT ID: jRCT2011240023

Registered date:09/07/2024

Basic Information

• Recruitment status: Pending

Health condition(s) or Problem(s) studied

Acute Leukemias
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia

• Date of first enrollment: 30/08/2024
• Target sample size: 150
• Countries of recruitment: Australia,Japan,Belgium,Japan,Canada,Japan,China,Japan,France,Japan,Israel,Japan,Republic of Korea,Japan,Kingdom of The Netherlands,Japan,Spain,Japan,Taiwan Province of China,Japan,United Kingdom of Great Britain And Northern Irela,Japan,United States of America,Japan
• Study type: Interventional

Intervention(s)

JNJ-75276617
JNJ-75276617 is administered orally.
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.

Outcome(s)

Primary Outcome

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Up to 4 years and 9 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
Up to 4 years and 9 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)
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.

Secondary Outcome

Plasma Concentration of JNJ-75276617
Up to 4 years and 9 months
Plasma concentration of JNJ-75276617 will be reported.

Overall Response Rate (ORR)
Up to 4 years and 9 months
ORR is based on investigator-determined responses and is defined as the percentage of participants who achieve any response.

Duration of Response (DOR)
Up to 4 years and 9 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)
Up to 4 years and 9 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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Relapsed or refractory acute leukemia and has exhausted, or is ineligible for, available therapeutic options
- Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin 98 gene or nucleoporin 214 gene (NUP98 or NUP214) alterations
- Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count less than or equal to (<=) 20 * 10^9/liter (L) (hydroxyurea may be used to lower WBC count at screening and during study; cytoreductive therapy may be considered with sponsor approval; (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 (>=) 50 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 or 1.
- A participant 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 participant 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

Exclude criteria

- 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)
- Prior cancer immunotherapy 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)

Related Information

• Primary Sponsor: Nakama Takahiro
• Secondary ID(s): NCT04811560