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Monoclonal Antibodies

JNJ-75276617 + Conventional Chemotherapy for Acute Leukemia

Q: 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 <a href="https://www.withpower.com/clinical-trials/new-york">New York</a><a href="https://www.withpower.com/clinical-trials/cancer">r Canc</a><a href="https://www.withpower.com/clinical-trials/utah"> of </a>Utah in Salt Lake City, Dana-Farber Cancer Institute in Boston, and Memorial Sloan Kettering in New York.

Q: 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.

Q: 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.

Q: 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.

Q: 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.

Q: 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 <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>. 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.

Dr. Von Haunersches Kinderspital der Universitaet Muenchen, Munchen, Germany

Targeting 4 different conditionsJNJ-75276617 +6 morePhase 1Waitlist AvailableResearch Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A) or nucleophosmin 1 gene (NPM1) or nucleoporin (NUP98 or NUP214) alterations

Estimated or measured glomerular filtration rate >= 60 milliliter per minute per 1.73 meter square (mL/min/1.73m^2) based on the bed side schwartz formula

Must not have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 3 years 5 months

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Acute Leukemia
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years 5 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Fludarabine

2012

Completed Phase 3

~1090

Pegaspargase

2005

Completed Phase 3

~9010

Vincristine

2003

Completed Phase 4

~2920

Cytarabine

2016

Completed Phase 3

~3250

Dexamethasone

2007

Completed Phase 4

~2590

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

961 Previous Clinical Trials

6,377,810 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

738 Previous Clinical Trials

3,958,344 Total Patients Enrolled

Media Library

JNJ-75276617 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05521087 — Phase 1

Acute Leukemia Research Study Groups: Arm B: >=2 Years Old, Arm A: <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 r Canc 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.

All > Acute Myeloid Leukemia