A Phase III Randomized, Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell With Marrow Transplantation From Human Leukocyte Antigen (HLA) Compatible Unrelated Donors (BMT CTN #0201)
The study is designed as a Phase III, randomized, open label, multicenter, prospective, comparative trial of granulocyte colony stimulating factor (G-CSF)-mobilized peripheral blood stem cells (PBSC) versus marrow from unrelated donors for transplantation in patients with hematologic malignancies. Recipients will be stratified by transplant center and disease risk and will be randomized to either the PBSC or marrow arm in a 1:1 ratio.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- Laura Johnston, MD
- Robert Negrin, M.D.
- Wen-Kai Weng, MD, PhD
- Robert Lowsky, MD
- Norman H. Silverman
- Sally Arai, MD
- Ginna G. Laport
- Judith Shizuru, Ph.D., M.D.
- Kenneth Weinberg
- biological : Peripheral blood stem cell transplantation
- biological : Allogeneic bone marrow transplantation
Phase: Phase 3
Ages Eligible For Study:
One of the following diagnoses: - Acute myelogenous leukemia at the following stages: first remission, second remission, third or subsequent remission, or not in remission - Acute lymphoblastic leukemia at the following stages: first remission, second remission, third or subsequent remission, or not in remission - Chronic myelogenous leukemia at the following stages: chronic phase, accelerated phase, or blast phase - Myelodysplastic syndromes (MDS) at the following stages: refractory anemia; refractory anemia with ringed sideroblasts; refractory cytopenia with multilineage dysplasia; refractory cytopenia with multilineage dysplasia and ringed sideroblasts; refractory anemia with excess blasts-1 (5-10% blasts); refractory anemia with excess blasts-2 (10-20% blasts); myelodysplastic syndrome, unclassified; or MDS associated with isolated del (5q) - Myeloproliferative diseases: chronic myelomonocytic leukemia; agnogenic myeloid metaplasia with myelofibrosis (idiopathic myelofibrosis); juvenile myelomonocytic leukemia - Therapy-related acute myelogenous leukemia (AML) or MDS with prior malignancy that has been in remission for at least 12 months. If the remission is less than 12 months, Medical Monitor or Protocol Chair approval is required for eligibility Patient