Peripheral Blood Stem Cell Transplant vs Bone Marrow Transplant in Individuals With Hematologic Cancers (BMT CTN 0201)
Leukemia, Myeloproliferative Disorders, Myelodysplastic-Myeloproliferative Diseases
About this trial
This is an interventional treatment trial for Leukemia
Eligibility Criteria
Patient Inclusion Criteria: 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 Exclusion Criteria: Prior allogeneic or autologous transplants using any hematopoietic stem cell source; patients with secondary malignancies who have had a prior autologous transplant will be eligible; the prior autologous transplant must have been performed for the primary malignancy (such as lymphoma) and must have occurred 12 or more months prior to enrollment Lymphoma (11% of 2001 NMDP transplants), other malignant disorders (6%), and non-malignant disorders (9%) Donor Inclusion Criteria: Matched for HLA-A, B, and DRB1 antigens One antigen mismatch at HLA-A, B, or DRB1 is acceptable with or without mismatch at HLA-C Typing is by DNA techniques: intermediate resolution for A, B, and C, and high resolution for DRB1. HLA-C typing is mandatory but will not count in the match. Willing to undergo both bone marrow harvest and G-CSF administration with apheresis Willing to be randomly assigned to either marrow or PBSC collection Adequate peripheral venous access for leukapheresis or willing to undergo placement of a central catheter Donor center affiliation with NMDP Additional donor inclusion criteria can be found in the Donor Companion Manual Donor Exclusion Criteria: Pregnant (positive serum β-HCG) or uninterruptible breastfeeding Known allergy to G-CSF or to E. Coli-derived recombinant protein products History of autoimmune disorders History of deep vein thrombosis or venous thromboembolism History of iritis or episcleritis History of serious adverse reaction to anesthesia Thrombocytopenia (platelets less than 150,000 per mcL) at baseline evaluation Current treatment with lithium Presence of sickle hemoglobin as demonstrated by appropriate testing such as hemoglobin electrophoresis Receiving experimental therapy or investigational agents
Sites / Locations
- University of Alabama at Birmingham
- City of Hope National Medical Center
- UCSD Cancer Center
- University of California, San Francisco
- Stanford Hospital and Clinics
- University of Florida College of Medicine (Shands)
- Emory University
- Loyola University
- IBMT (Indiana Blood and Marrow Transplant) at St Francis Franciscan Health
- University of Iowa Hospitals and Clinics
- University of Kansas Hospital
- University of Maryland
- DFCI/Brigham & Women's
- University of Michigan Medical Center
- University of Minnesota
- Mayo Clinic Cancer Center
- Washington University/Barnes Jewish Hospital
- Washington University/St. Louis Children's Hospital
- University of Nebraska Medical Center
- Hackensack University Medical Center Cancer Center
- Roswell Park Cancer Institute
- Cohen Children's Hospital
- Duke University Medical Center
- Wake Forest University Health Sciences
- Ohio State/Arthur G. James Cancer Hospital
- University of Oklahoma Medical Center
- Oregon Health & Science University (Peds)
- Oregon Health Sciences University
- University of Pennsylvania Cancer Center
- University of Pittsburgh Cancer Institute
- Vanderbilt University
- Baylor University Medical Center
- Baylor College of Medicine/The Methodist Hospital
- University of Texas/MD Anderson CRC
- Texas Transplant Institute
- Utah BMT/Primary Children's Medical Center
- Utah BMT/University of Utah Medical School
- Virginia Commonwealth University MCV Hospitals
- Fred Hutchinson Cancer Research Center
- Tom Baker Cancer Centre, Calgary
- Vancouver General Hospital
- Hamilton Health Sciences - McMaster Site
- Ottawa Hospital
- University of Toronto, Princess Margaret Hospital
- Queen Elizabeth II Health Sciences Centre - Halifax
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Bone Marrow Transplant
Blood Stem Cell Transplant
Allogeneic bone marrow transplantation
Peripheral blood stem cell transplantation