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

Conditions

• Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
• Recurrent Acute Myeloid Leukemia
• Recurrent Secondary Acute Myeloid Leukemia
• Refractory Acute Myeloid Leukemia
• Refractory Secondary Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Azacitidine — DRUG
  Given IV or SC
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Marrow Aspiration — PROCEDURE
  Undergo bone marrow aspiration and biopsy
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow aspiration and biopsy
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Punch Biopsy — PROCEDURE
  Undergo skin punch biopsy
• Questionnaire Administration — OTHER
  Ancillary studies
• Ruxolitinib — DRUG
  Given PO
• Venetoclax — DRUG
  Given PO

Study Details

This 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.

Key Dates

Start date

Aug 16, 2019

Status verified

Mar 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

51 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1 (ruxolitinib, venetoclax)
  Patients receive ruxolitinib PO BID and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive additional cycles of ruxolitinib and venetoclax at the discretion of the sponsor-investigator. Patients also undergo a skin punch biopsy and ECHO at screening and blood sample collection and bone marrow aspiration and biopsy throughout the study. (COMPLETE 04/04/2025)
• Experimental: Arm 2 (ruxolitinib,venetoclax, azacitidine)
  Patients receive ruxolitinib PO BID, venetoclax PO QD, and azacitidine IV or SC on days 1-7 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO at screening and blood sample collection and bone marrow aspiration and biopsy throughout the study.

Primary Outcome Measure

Dose-limiting toxicities (DLT) for each arm-specific combination [ Time Frame: Up to day 56 (of cycle 1 [cycle length = 28 days]) for non-hematologic DLT and up to day 42 (of cycle 1 [cycle length = 28 days]) for hematologic DLTs ]

Locations (3)

Find similar trials in Columbus, OH

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