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Monoclonal Antibodies

JNJ-75276617 + Chemotherapy for Acute Leukemia

Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years 5 months
Awards & highlights

Study Summary

This trial is testing a new drug, JNJ-75276617, to see if it is effective in treating pediatric and young adult patients with leukemia that has come back or does not respond to treatment.

Who is the study for?
This trial is for young people with relapsed/refractory acute leukemia who have specific genetic changes (KMT2A, NPM1, or nucleoporin). They must be fairly active and have good kidney function. It's not for those with certain bone marrow syndromes, recent transplants, prior menin-KMT2A inhibitor treatment, uncontrolled graft-versus-host disease, Down syndrome associated leukemia or recent immunotherapy.Check my eligibility
What is being tested?
The study tests JNJ-75276617 combined with standard chemotherapy to find the safest dose in kids and young adults with specific genetic types of acute leukemia. Part 1 figures out the right doses; Part 2 checks safety at these doses and also looks at JNJ-75276617 alone in some cases.See study design
What are the potential side effects?
Possible side effects include reactions related to JNJ-75276617 and common chemo effects like nausea, hair loss, fatigue, increased infection risk due to low blood cell counts, mouth sores and potential organ damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years 5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with AEs by Severity
Number of Participants with Adverse Events (AEs)
Number of Participants with Dose-Limiting Toxicity (DLT)
Secondary outcome measures
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 Depletion of Leukemic Blasts
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: >=2 Years OldExperimental Treatment7 Interventions
Participants aged greater than or equal to (>=) 2 years old in dose escalation portion of the study will receive JNJ-75276617 orally on a 28-day cycle. Starting dose of JNJ-75276617 is based on the adult dose from the ongoing study NCT04811560 with additional dose reductions based on age. Further dose levels will be escalated based on the DLT evaluation by SET until the RP2Ds has been identified. Participants in dose expansion portion of the study will receive JNJ-75276617 orally at one of the RP2D(s) determined in dose escalation portion, in 3 cohorts divided on the basis of disease diagnosis. Participants with AML and B-cell ALL will receive conventional chemotherapy backbone regimen (dexamethasone, vincristine, pegaspargase, fludarabine, cytarabine and intrathecal chemotherapy) in combination with JNJ-75276617.
Group II: Arm A: <2 Years OldExperimental Treatment7 Interventions
Participants aged less than (<) 2 years old in dose escalation portion of the study will receive JNJ-75276617 orally on a 28-day cycle. Starting dose of JNJ-75276617 is based on the adult dose from the ongoing study NCT04811560 with additional dose reductions based on age. Further 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 dose expansion portion of the study will receive JNJ-75276617 orally at one of the RP2D(s) determined in dose escalation portion of the study, in 3 cohorts divided on the basis of disease diagnosis. Participants with acute myeloid leukemia (AML) and B-cell acute lymphoblastic leukemia (ALL) will receive conventional chemotherapy backbone regimen (dexamethasone, vincristine, pegaspargase, fludarabine, cytarabine and intrathecal chemotherapy) in combination with JNJ-75276617.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Cytarabine
2016
Completed Phase 3
~3310
Pegaspargase
2005
Completed Phase 3
~9010
Fludarabine
2012
Completed Phase 3
~1100
Vincristine
2003
Completed Phase 4
~2910

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,228 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,825 Total Patients Enrolled

Media Library

JNJ-75276617 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05521087 — Phase 1
Acute Leukemia Research Study Groups: Arm A: <2 Years Old, Arm B: >=2 Years Old
Acute Leukemia Clinical Trial 2023: JNJ-75276617 Highlights & Side Effects. Trial Name: NCT05521087 — Phase 1
JNJ-75276617 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05521087 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare institutions are conducting this experiment?

"There are 12 different locations across the country that will be facilitating this trial, including but not limited to University of Utah in Salt Lake City, Dana-Farber Cancer Institute in Boston, and Memorial Sloan Kettering in New york."

Answered by AI

Has JNJ-75276617 been given regulatory approval by the FDA?

"The safety of JNJ-75276617 has been accorded a score of 1 due to the limited amount of clinical information available from Phase 1 trials."

Answered by AI

Is this trial still looking for participants?

"Unfortunately, according to the information available on clinicaltrials.gov, this trial is no longer recruiting participants. The study was first announced December 22nd 2022 and had its last update November 3rd of the same year. Though not currently enrolling individuals into this particular medical assessment, 1601 other trials are actively seeking patients at present."

Answered by AI

Does the eligibility criteria for this clinical investigation encompass individuals over 40 years old?

"This clinical trial is seeking participants aged between 30 days and 30 years. Additionally, 495 trials are in progress for minors and 1272 research projects are being conducted on geriatric individuals."

Answered by AI

What is the ultimate goal of this investigation?

"This clinical trial, which will take up to 3 years and 5 months, is primarily measuring the number of participants who experience dose-limiting toxicity (DLT). Secondary objectives include assessing plasma concentration levels of JNJ-75276617 as well as counting the amount of participants with depletion or differentiation in leukemic blasts."

Answered by AI

Does my profile fulfill the criteria for enrollment into this experiment?

"This clinical trial is seeking 80 individuals aged between 30 days and 30 years, diagnosed with leukemia. To be considered for enrollment, patients must also meet the following criteria: possessing certain genetic mutations of KMT2A or NPM1 or NUP98/NUP214 gene alterations; having a Lansky performance status score above 50 (for those under 16) or Karnofsky scale higher than 50% (for those over 16); estimated glomerular filtration rate exceeding 60 mL/min per 1.73 meters squared based on Schwartz formula assessment at the bedside."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias
2024. "A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05521087.
~53 spots leftby Sep 2026
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