Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib

Conditions

• Mutant IDH1 Inhibitor Olutasidenib

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Olutasidenib — DRUG
  Given by PO
• Venetoclax — DRUG
  Given by PO
• Decitabine — DRUG
  Given by IV
• Decitabine/cedazuridine — DRUG
  Given by PO

Study Details

To find a recommended combination dose of decitabine and venetoclax that can be given in combination with olutasidenib to participants with AML.

Key Dates

Start date

Aug 29, 2024

Status verified

May 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2029

Study Design

Enrollment

78 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Part 1
  Participants enrolled in Part 1, the dose of venetoclax/decitabine you receive will depend on when you join this study. Up to 3 dose levels will be tested. Up to 6 participants will be enrolled at each dose level. \- All participants will receive the same dose level of olutasidenib.
• Experimental: Part 2
  Participants enrolled in Part 2, you will receive venetoclax/decitabine at the recommended dose that was found in Part 1. \- All participants will receive the same dose level of olutasidenib.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

• Courtney DiNardo, MD
  (713) 794-1141
  [email protected]

Locations (3)

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