Phase1b/2 Trial Of AZA + APG1252 In Patients With High-Risk AML
ConditionAML
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
This is a phase Ib/II study that aims to investigate the safety, tolerability and explore the efficacy of BCL- XL inhibition in participants with high-risk AML.
Eligibility criteria
Qualifiers
Part II, Cohort B
AML-M6 or AML-M7 by FAB or having erythroid or megakaryocytic differentiation by WHO 2022 classification
High-risk MDS/AML with erythroid differentiation and no prior therapy
AML with MECOM rearrangement, including, but not limited to t(3;3), inv(3q), confirmed by conventional karyotype or FISH for MECOM rearrangement.
Disqualifiers
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.
Trial design
Treatments tested in this trial
- Azacitidine
- APG1252
Treatment groups
52 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov