JNJ-75276617 for Acute Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hosp. Univ. Fund. Jimenez Diaz, Madrid, SpainAcute Leukemia+2 MoreJNJ-75276617 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to find the best dose and to see if it is safe and tolerated.

Eligible Conditions
  • Acute Lymphoblastic Leukemia
  • Acute Leukemia
  • Acute Myeloid Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: Up to 2 years and 10 months

Year 2
Changes in Expression of Menin-histone-lysine N-methyltransferase 2A (KMT2A) Target Genes
Duration of Response (DOR)
Number of Participants with AEs by Severity
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Number of Participants with Depletion of Leukemic Blasts
Number of Participants with Differentiation of Leukemic Blasts
Overall Response Rate (ORR)
Plasma Concentration of JNJ-75276617
Time to Response (TTR)
Day 28
Part 1: Percentage of Participants with Dose-Limiting Toxicity (DLT)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

JNJ-75276617
1 of 1

Experimental Treatment

110 Total Participants · 1 Treatment Group

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

JNJ-75276617
Drug
Experimental Group · 1 Intervention: JNJ-75276617 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years and 10 months

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
933 Previous Clinical Trials
6,368,621 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
716 Previous Clinical Trials
3,950,762 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have acute leukemia that has come back after treatment or has not responded to treatment, and there are no other treatment options available for you.

Frequently Asked Questions

How many individuals have enrolled in this clinical experiment?

"The sponsor, Janssen Research & Development, LLC is responsible for recruiting a total of 110 participants that meet the clinical trial's eligibility requirements. NYU Langone Medical Center in New York City and Cityof Hope in Duarte, California are two of many locations where patients may have access to this medical study." - Anonymous Online Contributor

Unverified Answer

What is the geographic scope of this clinical investigation?

"This clinical trial is enrolling participants at NYU Langone Medical Center in New York, City of Hope in Duarte, California and the University of California San Francisco located in San Francisco alongside many other sites." - Anonymous Online Contributor

Unverified Answer

What outcomes is this medical investigation attempting to realize?

"The trial sponsor, Janssen Research & Development LLC, has reported that the primary outcome they will be measuring over a maximal 28 day cycle is Adverse Events (AEs) as an indicator of safety and tolerability. Secondary outcomes include Plasma Concentration of JNJ-75276617, Number of Participants with Depletion of Leukemic Blasts, and Duration of Response (DOR)." - Anonymous Online Contributor

Unverified Answer

Is there capacity for additional participants in this research endeavor?

"Affirmative. Clinicaltrials.gov records reflect that this medical research, which was initially uploaded on May 19th 2021, is recruiting now. A total of 110 participants need to be enrolled from 8 distinct locations." - Anonymous Online Contributor

Unverified Answer

Has JNJ-75276617 been accepted by the FDA yet?

"JNJ-75276617 has yet to be fully tested, so our team gave it a 1 on the safety scale. This is because Phase 1 trials are not intended to demonstrate efficacy or provide adequate data regarding its security." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.