A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies (NCT05453903) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies
United States196 participantsStarted 2022-10-04
Plain-language summary
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of bleximenib in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of bleximenib in combination with AML directed therapies at the RP2D(s) (dose expansion).
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* Adolescent participants (defined as greater than or equal to \[\>=\] 12 and less than \[\<\] 18 years of age) are only eligible for the relapsed/refractory (R/R) cohort (Arm A, cohort A4)
* Diagnosis of AML according to World Health Organization (WHO) criteria: a) De novo or secondary AML; b) relapsed/refractory (Arm A only); c) harboring KMT2A, NPM1, NUP98, or NUP214 alterations; d) Participants may receive emergency leukapheresis and/or cytarabine as cytoreductive therapy according to local practice guidelines
* Pretreatment clinical laboratory values meeting the following criteria -listed below: White blood cell (WBC) count: less than or equal to (\<=) 25\*10\^9 per liter (/L), adequate liver and renal function
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Adolescent participants only: Performance status \>70 by Lansky scale (for participants \<16 years of age) or \>70 Karnofsky scale (for participants \>16 years of age)
* A female 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 (or their legally authorized representative) 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 thi…
What they're measuring
1
Number of Participants with Adverse Events (AEs)
Timeframe: Up to 3 Years 3 months
2
Number of Participants with Adverse Events (AEs) by Severity
Timeframe: Up to 3 Years 3 months
3
Number of Participants with Dose-limiting Toxicity (DLT)