A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia

Conditions

• Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ivosidenib — DRUG
  Ivosidenib ( days 15 through 28 for cycle 1, then days 1 through 28 for each cycle thereafter)
• Azacitidine — DRUG
  Azacitidine (IV or SC per institutional preference, days 1 through 7)
• Venetoclax — DRUG
  Venetoclax (days 1 through 14)

Study Details

The researchers are doing this study to find out whether a 3-drug combination of ivosidenib, azacitidine, and venetoclax followed by maintenance therapy with ivosidenib alone is an effective treatment approach for people with newly diagnosed acute myeloid leukemia (AML) that has an IDH mutation. Maintenance therapy is additional treatment given to help keep cancer from coming back after it has disappeared following the first course of treatment. The researchers will also look at the safety of the treatment approach and what kind of a time commitment it involves for participants.

Key Dates

Start date

Jan 27, 2026

Status verified

Mar 2026

Primary completion

Jan 31, 2028

Completion

Jan 31, 2028

Study Design

Enrollment

45 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone
  Patients will be initially treated with 7 days of azacitidine (IV or SC per institutional preference, 14 days of venetoclax and 14 days of Ivosidenib daily, days 15 through 28 for cycle 1, then days 1 through 28 for each cycle thereafter).

Primary Outcome Measure

Event free survival [ Time Frame: 12 months ]

Central Contacts

• Kuo-Kai Chin, MD
  646-608-4415
  [email protected]
• Eytan Stein, MD
  646-608-3749

Locations (7)

Find similar trials in Basking Ridge, NJ

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