Overview

A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)

Status:
Not yet recruiting

Trial end date:
2027-08-31

Target enrollment:

Participant gender:

Summary

The Phase 1b, dose-finding parts of the study is to determine safety, tolerability, and preliminary efficacy of CC-486 (Onureg, oral azacitidine) in combination with venetoclax initially in the relapsed and/or refractory (R/R) AML participants who are ≥ 18 years of age, not eligible to receive further intensive therapy (Phase 1b, Part I); then in newly diagnosed AML participants who are ≥ 75 years of age, or ≥ 18 to 74 years of age with comorbidities that preclude the use of intensive induction chemotherapy or hematopoietic stem cell transplant (HSCT) (Phase 1b, Part II). Primary objective in Phase 1b is to establish maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) by evaluating safety and tolerability of CC-486 in combination with venetoclax. Key secondary objective is to assess the preliminary efficacy. Up to 4 dose levels of CC-486 with venetoclax may be explored. Once MTD is established in the R/R AML population, then safety and tolerability of this MTD will be evaluated in the newly diagnosed AML population. When MTD/RP2D is determined in the newly diagnosed AML population, then Phase 2 dose expansion part of the study will open for enrollment. Primary objective in Phase 2 is to assess efficacy of the RP2D of CC-486 and venetoclax in eligible newly diagnosed AML participants who are ≥ 75 years of age; or ≥ 18 to 74 years of age with comorbidities that preclude the use of intensive induction chemotherapy or HSCT. Key secondary objectives include evaluation of safety, overall response rate, time to response, duration of response, event-free survival, etc of this CC-486 and venetoclax combination in the frontline setting. This study is designed with the goal of developing CC-486 (oral azacitidine) as backbone for combination therapy to treat AML patients in the frontline setting.

Phase:

Phase 1

Details

Lead Sponsor:

Celgene

Collaborator:

AbbVie

Treatments:

Azacitidine
Cc-486
Venetoclax