OncoMatch/Clinical Trials/NCT03471260
Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies
Is NCT03471260 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Azacitidine and Ivosidenib for acute myeloid leukemia.
Treatment: Azacitidine · Ivosidenib · Venetoclax — This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with ivosidenib with or without azacitidine, in treating patients with IDH1-mutated hematologic malignancies. Venetoclax and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ivosidenib and venetoclax with azacitidine may work better in treating patients with hematologic malignancies compared to ivosidenib and venetoclax alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Myeloproliferative Neoplasm
Biomarker criteria
Required: IDH1 R132 mutation
IDH1-R132 mutated disease status as assessed by local laboratory
Allowed: IDH1 2HG-producing variant (e.g. R100)
2HG-producing IDH1 variants outside of R132 (i.e. R100) may be eligible after discussion with the PI
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: (ivosidenib, venetoclax)
Patients who have previously received either ivosidenib or venetoclax
Lab requirements
Kidney function
creatinine clearance > 30 ml/min based on the Cockcroft-Gault equation
Liver function
direct bilirubin < 2 x ULN, ALT and/or AST < 3x ULN unless deemed to be related to underlying leukemia
Adequate hepatic function (direct bilirubin < 2 x ULN, ALT and/or AST < 3x ULN) unless deemed to be related to underlying leukemia. Adequate renal function including creatinine clearance > 30 ml/min based on the Cockcroft-Gault equation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana-Farber Cancer Institute · Boston, Massachusetts
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center · Cleveland, Ohio
- Oregon Health and Science University · Portland, Oregon
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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