Pilot Study of Ex Vivo Expansion of Mafosfamide-Purged CD34-Positive Cells for Autologous Peripheral Blood Stem Cell or Bone Marrow Transplantation in Patients With Acute Leukemia
Patients will receive infusions of cyclophosphamide and an infusion or injection of G-CSF
once a day for 7-14 days followed by collection of their peripheral stem cells. Some
patients may also undergo bone marrow collection. Patients' stem cells and/or bone marrow
will be treated in the laboratory. Patients will then receive busulfan for 4 days followed
by cyclophosphamide for 4 days. Two days later, patients will undergo autologous peripheral
stem cell or bone marrow transplant and then receive an infusion or injection of G-CSF once
a day until blood counts return to normal.
The goal of this pilot clinical study is to shorten the duration of aplasia associated with
mafosfamide purged autologous transplants for acute leukemia using the cytokine cocktail of
recombinant human stem cell factor (rhSCF), recombinant human granulocyte colony stimulating
factor (rhG-CSF) and recombinant human thrombopoeitin (rhTPO) for ex vivo expansion.
After finishing treatment, patients will be evaluated periodically for at least 5 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the feasibility of ex vivo expanding a CD34 selected, mafosfamide purged autograft.
B. Douglas Smith, M.D.
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
United States: Food and Drug Administration
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