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RecruitingLast updated: 2 February 2024

Menin Umbrella: This phase I study is seeking to determine the effectiveness and appropriate dose level of a new drug (JNJ-75276617) in combination with other drugs (venetoclax and/or azacitidine) in people with acute myeloid leukaemiaA Phase 1b Study of JNJ-75276617 in Combination With AML Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations

Clinical summary

Summary

This study has two phases: dose selection and dose expansion. In the dose selection phase, participants with relapsed or refractor acute myeloid leukaemia (AML) with either NPM1 or KMT2A alterations will receive JNJ-75276617 in combination with venetoclax and/ or azacitidine to select the recommended phase 2 dose (RP2D) of JNJ-75276617 in combination with venetoclax and/or azacitidne. There will be three cohorts. Cohort A1 will receive JNJ-75276617 (orally) + venetoclax (orally). Cohort A2 will receive JNJ-75276617 (orally) + azacitidine (intravenously). Cohort A3 will receive JNJ-75276617 (orally) + venetoclax (orally) + azacitidine (intravenously). In the dose expansion phase of the study, participants will receive JNJ-75276617 in combination with AML directed therapies (venetoclax and/or azacitidine) at the RP2D(s).

Conditions

This trial is treating patients with acute myeloid leukaemia

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

Trial Acronym

Menin Umbrella

More information

Trial Identifiers

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Trial sponsor

Janssen Research & Development, LLC

Scientific Title

A Phase 1b Study of JNJ-75276617 in Combination With AML Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations

Eligibility

Inclusion

  • Diagnosis of AML according to World Health Organization (WHO) criteria: a) De novo or secondary AML; b) relapsed /refractory (Arm A only); c) harboring NPM1 / KMT2A alterations
  • Pretreatment clinical laboratory values meeting the following criteria -listed below: White blood cell (WBC) count: less than or equal to <=25 x 10^9 per liter (/L), adequate liver and renal function
  • ECOG performance status grade of 0, 1 or 2
  • A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
  • 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.
  • Willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion

  • Acute promyelocytic leukemia according to WHO 2016 criteria
  • Leukemic involvement of the central nervous system
  • Recipient of solid organ transplant
  • Cardiovascular disease that is uncontrolled, increases risk for Torsades de Pointes or that was diagnosed within 6 months prior to the first dose of study treatment including, but not limited to:(a) Myocardial infarction; (b) Severe or unstable angina; (c) Clinically significant cardiac arrhythmias, including bradycardia (less than [<] 50 beats per minute); (d) Uncontrolled (persistent) hypertension: (example, blood pressure greater than [>] 140/90 millimeters of mercury [mm Hg]; (e) Acute neurologic events such as stroke or transient ischemic attack, intracranial or subarachnoid hemorrhage, intracranial trauma; (f) Venous thromboembolic events (example, pulmonary embolism) within 1 month prior to the first dose of study treatment (uncomplicated Grade less than or equal to [≤]2 deep vein thrombosis is not considered exclusionary);(g)Congestive heart failure (NYHA class III to IV); (h) Pericarditis or clinically significant pericardial effusion; (i) Myocarditis; (j) Endocarditis (k) Clinically significant hypokalemia, hypomagnesemia, hypocalcemia (corrected for hypoalbuminemia)
  • Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to grade 1 or less
  • Pulmonary compromise that requires the need for supplemental oxygen use to maintain adequate oxygenation

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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