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OncoMatch/Clinical Trials/NCT03874052

Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Is NCT03874052 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Azacitidine and Ruxolitinib for acute myeloid leukemia arising from previous myelodysplastic syndrome.

Phase 1RecruitingJennifer SaultzNCT03874052Data as of May 2026

Treatment: Azacitidine · Ruxolitinib · VenetoclaxThis phase I trial studies the side effects and best dose of ruxolitinib when given together with venetoclax and compares the effect of ruxolitinib in combination with venetoclax to venetoclax and azacitidine in treating patients with acute myeloid leukemia (AML) that has come back (relapsed) or has not responded to treatment (refractory). Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Azacitidine stops cells from making deoxyribonucleic acid and may kill cancer cells. It is a type of antimetabolite. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving ruxolitinib in combination with venetoclax and azacitidine may be safe, tolerable, and/or effective compare to ruxolitinib with venetoclax in treating patients with relapsed or refractory AML.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: any prior therapy for AML

has progressed after at least 1 prior therapy for AML

Lab requirements

Kidney function

Creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hour urine collection

Liver function

Total serum bilirubin ≤ 1.5 x ULN unless thought to be due to leukemic involvement; AST and/or ALT ≤ 3.0 x ULN unless thought to be due to leukemic involvement

Creatinine clearance ≥ 30 mL/min; Total serum bilirubin ≤ 1.5 x ULN unless thought to be due to leukemic involvement; AST and/or ALT ≤ 3.0 x ULN unless thought to be due to leukemic involvement

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Ohio State University Comprehensive Cancer Center · Columbus, Ohio
  • OHSU Knight Cancer Institute · Portland, Oregon
  • UT Southwestern/Simmons Cancer Center-Dallas · Dallas, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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