A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia

  • STATUS
    Recruiting
  • End date
    Jan 25, 2025
  • participants needed
    43
  • sponsor
    Celgene
Updated on 7 October 2022
hydroxyurea
azacitidine
refractory acute myeloid leukemia (aml)
flt3 internal tandem duplication
venetoclax

Summary

CC-90009-AML-002 is an exploratory Phase 1b, open-label, multi-arm trial to evaluate the safety and efficacy of CC-90009 in combination with anti-leukemia agents in participants with acute myeloid leukemia (AML).

Description

Study CC-90009-AML-002 is an open-label, multi-arm, parallel multi-cohort, multicenter, Phase 1b study to determine the safety, tolerability, PK, and efficacy of CC 90009 in combination with anti-leukemia agents used for the treatment of AML. CC 90009 will be given as a combination therapy to subjects with newly diagnosed (ND) or relapsed or refractory (R/R) AML.

The dose and schedule finding part (Part A) of the study will evaluate the safety, PK and PD data, and preliminary efficacy information and determine the Part B dose and schedule for each arm.

The expansion part (Part B) of the study will further evaluate the safety and efficacy of the CC-90009 containing combination at or below the maximum tolerated dose (MTD) in the selected cohorts in order to determine the recommended Phase 2 dose (RP2D) for subjects with AML.

Details
Condition Leukemia, Myeloid, Acute
Treatment Azacitidine, Gilteritinib, venetoclax, CC-90009
Clinical Study IdentifierNCT04336982
SponsorCelgene
Last Modified on7 October 2022

Eligibility

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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