JNJ-75276617 for leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Great Ormond Street Hospital, London, United Kingdom
leukemia+6 More
JNJ-75276617 - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 ([KMT2A1], nucleophosmin 1 gene (NPM1), or nucleoporin alterations in Part 1 (Dose Escalation) and to further evaluate safety at the RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 (Dose Expansion).

Eligible Conditions

  • leukemia
  • Leukemia, Myelocytic, Acute
  • Acute Lymphoblastic Leukemia (ALL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for leukemia

Study Objectives

3 Primary · 9 Secondary · Reporting Duration: Up to 3 years 5 months

Cycle 1 (28 days)
Number of Participants with Dose-Limiting Toxicity (DLT)
Year 5
Changes in Expression of Menin-histone-lysine N-methyltransferase 2A (KMT2A) Target Genes or Genes Associated With Differentiation
Duration of Response (DOR)
Number of Participants with AEs by Severity
Number of Participants with Adverse Events (AEs)
Number of Participants with Depletion of Leukemic Blasts
Number of Participants with Differentiation of Leukemic Blasts
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)
Percentage of Participants With Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Plasma Concentration of JNJ-75276617
Time to Response (TTR)

Trial Safety

Safety Progress

1 of 3

Other trials for leukemia

Trial Design

2 Treatment Groups

Arm A: <2 Years Old
1 of 2
Arm B: >=2 Years Old
1 of 2
Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: JNJ-75276617 · No Placebo Group · Phase 1

Arm A: <2 Years OldExperimental Group · 7 Interventions: Fludarabine, Intrathecal Chemotherapy, Pegaspargase, Vincristine, Cytarabine, Dexamethasone, JNJ-75276617 · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug
Arm B: >=2 Years OldExperimental Group · 7 Interventions: Fludarabine, Intrathecal Chemotherapy, Pegaspargase, Vincristine, Cytarabine, Dexamethasone, JNJ-75276617 · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 2
~1240
Pegaspargase
2005
Completed Phase 3
~9040
Vincristine
2003
Completed Phase 4
~2820
Cytarabine
2016
Completed Phase 3
~3090
Dexamethasone
2007
Completed Phase 4
~2420

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years 5 months
Closest Location: Dana-Farber Cancer Institute · Boston, MA
Photo of Boston 1Photo of Boston 2Photo of Boston 3
2007First Recorded Clinical Trial
0 TrialsResearching leukemia
923 CompletedClinical Trials

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
916 Previous Clinical Trials
6,326,788 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
705 Previous Clinical Trials
3,900,083 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.