A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia (NCT05326516) | Clinical Trial Compass
CompletedPhase 1
A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia
United States30 participantsStarted 2022-03-09
Plain-language summary
The purpose of this study is to determine the safety and tolerability of revumenib when given in combination with 2 different chemotherapy regimens in participants with relapsed/refractory acute leukemias harboring KMT2A rearrangement, KMT2A amplification, NPM1c, or NUP98r.
Who can participate
Age range30 Days
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Participants must have documented relapsed or refractory (R/R) AML, ALL, or acute leukemias of ambiguous lineage (ALAL) including MPAL and acute undifferentiated leukemia (AUL) harboring KMT2A rearrangement, KMT2A amplification, NPM1c, or NUP98r.
* White blood count must be \<25,000/microliter prior to the first dose of revumenib. Participants may receive cytoreduction per protocol prior to beginning revumenib.
* Eastern Cooperative Oncology Group performance status score 0-2 (if aged ≥18 years); Karnofsky Performance Scale of ≥50 (if aged ≥16 years and \<18 years); Lansky Performance Score of ≥50 (if aged \<16 years).
* Adequate liver, kidney, and cardiac function
* Participant must be taking 1 of the following medications for antifungal prophylaxis: itraconazole, ketoconazole, posaconazole, or voriconazole.
* A female of childbearing potential must agree to use a highly effective method of contraception or double barrier method from the time of enrollment through 120 days following the last study drug dose.
* A male of childbearing potential must agree to use barrier contraception from the time of enrollment through 120 days following the last study drug dose.
Key Exclusion Criteria:
* Any unresolved ≥Grade 2 reversible toxicity from previous anticancer therapy except alopecia or Grade 2 neuropathy
* Graft-Versus-Host Disease (GVHD): Signs or symptoms of acute or chronic GVHD \>Grade 0 within 4 weeks of enrollment. All transplant participants…
What they're measuring
1
Number of Participants With Dose Limiting Toxicities From Revumenib
Timeframe: Day 1 through up to 30 days after last dose of study intervention
2
Number of Participants With Treatment-emergent Adverse Events
Timeframe: Day 1 through up to 30 days after last dose of study intervention