A Phase III Randomized, Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell With Marrow Transplantation From HLA Compatible Unrelated Donors.
This study is a randomized, open-label, multicenter, prospective, comparative trial of
granulocyte colony stimulating factor (G-CSF) mobilized peripheral blood stem cells verses
marrow from unrelated donors for transplantation in patients with hematologic malignancies.
The study will be comparing two-year survival probabilities between process has many steps
after a matched donor is found. The donor also needs to give permission to join this study.
Participants will be randomized to either peripheral blood stem cells (PBSC) or bone marrow.
The kind of transplant the participant receives is random. Neither the participant nor the
doctor may choose the type of transplant.
Participants will receive vaccinations for diphtheria, tetanus, hepatitis B and
pneumococcus. Blood samples will be drawn as part of a participant's normal care. Blood
samples will also be collected to see if infection fighting cells are working. These samples
will be collected at 12 weeks, one year and then yearly until three years post transplant.
Information will be collected from the participant's medical history. Participants will also
have phone interviews conducted and questions will be asked about their physical and
emotional health. Participants taking part in this study may be followed for up to 5 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective is to compare two-year survival probabilities between patients in the two study arms using an intent-to-treat analysis
Shakila P. Khan, M.D.
United States: Institutional Review Board
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