Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing a new drug to see what dose is safe to use with other treatments for AML. They will also expand to study the safety and tolerability of the new drug at the recommended Phase 2 dose. The drug JNJ-75276617 is being used to treat acute myeloid leukemia and has previously been approved by the FDA for a different condition. This treatment is free and there will be no placebo group in this trial.
Eligible Conditions
- Leukemia, Myeloid, Acute
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 10 Secondary · Reporting Duration: Up to 2 Years
Up to 2 Years
Changes in Expression of Menin-histone-lysine N-methyltransferase 2A (KMT2A) Target Genes
Duration of response
Number of Participants with Adverse Events (AEs)
Number of Participants with Adverse Events (AEs) by Severity
Number of Participants with Depletion of Leukemic Blasts
Number of Participants with Differentiation of Leukemic Blasts
Percentage of Participants who Achieve Complete Remission (CR)
Percentage of Participants who Achieve Complete Remission with Partial Hematologic Recovery (CRh)
Percentage of Participants who Achieved Overall Response
Plasma Concentration of JNJ- 75276617
Time to Response
Up to 2 years
Percentage of Participants who Achieve Complete Remission with Incomplete Hematologic Recovery (CRi)
Day 28
Number of Participants with Dose-limiting Toxicity (DLT)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Arm A: Relapsed/Refractory Setting
1 of 1
Experimental Treatment
150 Total Participants · 1 Treatment Group
Primary Treatment: JNJ-75276617 · No Placebo Group · Phase 1
Arm A: Relapsed/Refractory SettingExperimental Group · 3 Interventions: JNJ-75276617, Venetoclax (VEN), Azacitidine (AZA) · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine (AZA)
2012
Completed Phase 1
~10
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Closest Location: Massachusetts General Hospital · Boston, MA
1993First Recorded Clinical Trial
66 TrialsResearching Leukemia, Myeloid, Acute
2440 CompletedClinical Trials
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
917 Previous Clinical Trials
6,326,563 Total Patients Enrolled
8 Trials studying Leukemia, Myeloid, Acute
832 Patients Enrolled for Leukemia, Myeloid, Acute
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
706 Previous Clinical Trials
3,899,858 Total Patients Enrolled
8 Trials studying Leukemia, Myeloid, Acute
832 Patients Enrolled for Leukemia, Myeloid, Acute
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You must sign an informed consent form (ICF) indicating participant understands the purpose of the study and procedures required for the study and is willing to participate in the study.
You are willing and able to adhere to the prohibitions and restrictions specified in this protocol.
You have a WBC count of less than or equal to 25 x 10^9 per liter (<25 x 10^9 per L) or adequate liver and renal function.
About The Reviewer
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.
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