Trial Search Results
Peripheral Blood Stem Cell Transplant vs Bone Marrow Transplant in Individuals With Hematologic Cancers (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 currently not accepting patients for this trial.
Lead Sponsor:
Medical College of Wisconsin
Collaborator: National Marrow Donor Program
Stanford Investigator(s):
Intervention(s):
- Biological: Allogeneic bone marrow transplantation
- Biological: Peripheral blood stem cell transplantation
Phase:
Phase 3
Eligibility
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
1. One antigen mismatch at HLA-A, B, or DRB1 is acceptable with or without mismatch
at HLA-C
2. 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
Ages Eligible for Study
N/A - 66 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Physician Referrals
650-723-0822
Not Recruiting