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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Azacitidine
Drug
Given by IV
APG1252
Drug
Given by IV

Treatment groups

52 Participants

are divided into 3 treatment groups

Group A: Cohort A: Part II Cohort A Treatment with Azacitidine (IV or SQ) + APG1252 (IV) Q4W R/R AMLExperimental treatment 2 interventions

Group B: Cohort B: Part II Cohort B Treatment with Azacitidine (IV or SQ)+APG1252 (IV) Q4W untreated AMLExperimental treatment 2 interventions

Group C: Lead-In: Part I Lead-In Treatment with Azacitidine (IV or SQ) + APG1252 (IV) Q4W R/R AMLExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Safety and Adverse Events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame

Through study completion; an average of 1 year.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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