CD34+ Transplants for Leukemia and Lymphoma

Part of paid clinical trials in Miami, Florida.

Sponsor
Guenther Koehne
Study ID
NCT05565105
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Leukemia, Lymphocytic, Acute
  • Leukemia, Myeloid, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Total Body Irradiation (TBI) — RADIATION
    Hyper-fractioned TBI is administered by a linear accelerator at a dose rate of \< 15 cGy/minute.
  • Thiotepa — DRUG
    Thiotepa: 5 mg/kg/day IV over approximately 4 hours daily x 2 (Day -5 and Day -4).
  • Cyclophosphamide — DRUG
    Cyclophosphamide: 60 mg/kg/day x 2 or Fludarabine 25 mg/m\^2 x 5 if cyclophosphamide is contraindicated
  • Busulfan — DRUG
    Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics
  • Melphalan — DRUG
    Melphalan: 70 mg/m\^2/day x 2
  • Fludarabine — DRUG
    Fludarabine: 25 mg/m\^2/day x 5

Study Details

This study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in less complications for patients undergoing transplant for treatment of a blood malignancy (cancer) or blood disorder.

Key Dates

Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2033
Completion
Jun 30, 2033

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen A: TBI/Thiotepa/Cyclophosphamide
    Patients in enrolled in Regimen A will receive the following: * Total Body Irradiation (TBI), hyper-fractionated to a dose of 1320 cGy depending on age, stage of disease and requirement of general anesthesia with lung shielding * Thiotepa, 5 mg/kg/day x 2 days via IV infusion over 4 hours daily or 10 mg/kg on one day * Cyclophosphamide, 60 mg/kg/day x 2 days via IV infusion over 2 hours daily (or if cyclophosphamide is contraindicated, fludarabine at 25 mg/m\^2 x 5 days may be substituted)
  • Experimental: Regimen B: Busulfan/Melphalan/Fludarabine
    Patients in enrolled in Regimen B will receive the following: * Busulfan, IV 0.8 mg/kg q6hours x 10 or 12 doses over 3 days, depending on the disease * Melphalan, 70 mg/m\^2/day x 2 days via IV infusion over 30 minutes daily * Fludarabine, 25 mg/m\^2/day x 5 days via IV infusion over 30 minutes daily

Primary Outcome Measure

Incidence rate of graft versus host disease (GvHD) [ Time Frame: Two years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baptist Health South Florida/Miami Cancer InstituteMiamiFlorida33176
Guenther Koehne, MD, Ph.D.
[email protected]
786-596-2000

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By research site
Baptist Health South Florida/Miami Cancer Institute· Miami, FL

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