Peripheral Blood Stem Cell Transplant vs Bone Marrow Transplant in Individuals With Hematologic Cancers (BMT CTN 0201)

Not Recruiting

Trial ID: NCT00075816

Purpose

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.

Official Title

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)

Stanford Investigator(s)

Wen-Kai Weng, MD, PhD
Wen-Kai Weng, MD, PhD

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Sally Arai
Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Judith Shizuru
Judith Shizuru

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

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

Intervention(s):

biological: Allogeneic bone marrow transplantation

biological: Peripheral blood stem cell transplantation

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Physician Referrals
650-723-0822

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