A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias

Phase 1

Withdrawn

• Conditions: Acute Leukemias; Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Acute Leukemia of Ambiguous Lineage

• Registration Number: NCT05521087
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-8-29
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Inclusion Criteria:<br><br> - Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A) or<br> nucleophosmin 1 gene (NPM1) or nucleoporin (NUP98 or NUP214) alterations<br><br> - Performance status greater than or equal to (>=) 50 by lansky scale (for<br> participants less than [<] 16 years of age) or >=50 percent (%) karnofsky scale (for<br> participants >=16 years of age)<br><br> - Estimated or measured glomerular filtration rate >= 60 milliliter per minute per<br> 1.73 meter square (mL/min/1.73m^2) based on the bed side schwartz formula<br><br>Exclusion Criteria:<br><br> - Received an allogeneic hematopoietic transplant within 60 days of screening<br><br> - Active acute graft-versus-host disease of any grade or chronic graft-versus-host<br> which is not well-controlled<br><br> - Received immunosuppressive therapy post hematopoietic transplant within 30 days of<br> enrollment<br><br> - Diagnosis of Down syndrome associated leukemia, acute promyelocytic leukemia,<br> juvenile myelomonocytic leukemia<br><br> - Diagnosis of fanconi anemia, kostmann syndrome, shwachman diamond syndrome, or any<br> other known bone marrow failure syndrome<br><br> - Prior exposure to menin-KMT2A inhibitors<br><br> - Prior cancer immunotherapy (ie [that is], Chimeric Antigen Receptor-T Cell Therapy<br> [CAR-T], inotuzumab, gemtuzumab ozogamicin) within 4 weeks prior to enrollment or<br> blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies<br> must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent<br> (whichever is shorter)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs);Number of Participants with AEs by Severity;Number of Participants with Dose-Limiting Toxicity (DLT)

Secondary Outcome Measures

Name	Time	Method
Plasma Concentration of JNJ-75276617;Number of Participants with Depletion of Leukemic Blasts;Number of Participants with Differentiation of Leukemic Blasts;Changes in Expression of Menin-histone-lysine N-methyltransferase 2A (KMT2A) Target Genes or Genes Associated With Differentiation;Overall Response Rate (ORR) per Response Criteria in Acute Myeloid Leukemia (AML);Overall Response Rate (ORR) per the Response Criteria in B-cell Acute Lymphoblastic Leukemia (ALL);Time to Response (TTR);Duration of Response (DOR);Percentage of Participants With Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)