Status:
COMPLETED
Peripheral Blood Stem Cell Transplant vs Bone Marrow Transplant in Individuals With Hematologic Cancers (BMT CTN 0201)
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Blood and Marrow Transplant Clinical Trials Network
Conditions:
Leukemia
Myeloproliferative Disorders
Eligibility:
All Genders
Up to 66 years
Phase:
PHASE3
Brief Summary
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) ...
Detailed Description
BACKGROUND: Many studies of allogeneic marrow transplantation have shown that a higher dose of marrow cells correlates with more robust hematopoietic engraftment and lower mortality from infectious c...
Eligibility Criteria
Inclusion
- Patient
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
551 Patients enrolled
Trial Details
Trial ID
NCT00075816
Start Date
January 1 2004
End Date
April 1 2014
Last Update
January 4 2023
Active Locations (45)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
City of Hope National Medical Center
Duarte, California, United States, 91010
3
UCSD Cancer Center
La Jolla, California, United States, 92093-0960
4
University of California, San Francisco
San Francisco, California, United States, 94143