Venetoclax and Sequential Busulfan, Cladribine, and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome

Eligibility Criteria

Sex

ALL

Age

2 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
  Undergo allogeneic PBSCT
• Busulfan — DRUG
  Given IV
• Cladribine — DRUG
  Given IV
• Fludarabine Phosphate — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Peripheral Blood Stem Cell Transplantation — PROCEDURE
  Undergo allogeneic PBSCT
• Pharmacological Study — OTHER
  Correlative studies
• Venetoclax — DRUG
  Given PO

Study Details

This randomized phase II trial studies how well venetoclax and sequential busulfan, cladribine, and fludarabine phosphate before donor stem cell transplant work in treating patients with acute myelogenous leukemia or myelodysplastic syndrome. Giving chemotherapy before a donor peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells.

Key Dates

Start date

Oct 27, 2014

Status verified

Apr 2026

Primary completion

Oct 31, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

116 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (busulfan days -13 and -12 before PBSCT)
  PREPARATIVE REGIMEN: Patients receive venetoclax PO QD on days -22 to -3 and busulfan IV over 3 hours on days -13 and -12. Patients then receive fludarabine phosphate IV over 1 hour, cladribine IV over 2 hours, and busulfan IV over 3 hours on days -6 to -3. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.
• Experimental: Arm II (busulfan days -20 and -13 before PBSCT)
  PREPARATIVE REGIMEN: Patients receive venetoclax PO QD on days -22 to -3 and busulfan IV over 3 hours on days -20 and -13. Patients then receive fludarabine phosphate IV over 1 hour, cladribine IV over 2 hours, and busulfan IV over 3 hours on days -6 to -3. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.

Primary Outcome Measure

Progression free survival [ Time Frame: At 6 months ]

Locations (1)

Find similar trials in Houston, TX

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