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Protocol # 21-706

Status

Recruiting

Description

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-486 (ONUREG®) in combination with venetoclax in relapsed and/or refractory Acute Myeloid Leukemia (AML) and newly diagnosed AML.

Condition

  • Leukemia, Myeloid, Acute

Interventions

  • CC-486
  • Venetoclax

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Maximum Tolerated Dose (MTD)
  • Incidence of type of adverse events (AEs)
  • Incidence of frequency of AEs
  • Incidence of severity of AEs
  • Incidence of relationship of AEs to study treatment
  • Incidence of clinically significant changes in clinical laboratory results: Hematology tests
  • Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
  • Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

Secondary Outcome:

  • Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh)
  • Overall Response Rate (ORR)
  • Minimal Residual Disease (MRD) Response Rate
  • MRD Conversion Rate
  • Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi)

Enrollment

66

Study Start Date

December 1, 2021

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Celgene

Source

Celgene

Official title

A Phase 1B, Open-label, Global, Multicenter, Dose Determination Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of CC-486 (ONUREG®) in Combination Therapy in Subjects With Acute Myeloid Leukemia (AML)

Clinicaltrials.gov Identifier

NCT04887857

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.