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BMT CTN PROTOCOL 0201 Version 8.0 Study Chairperson

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BMT CTN PROTOCOL 0201 Version 8.0 Study Chairperson A Phase III Randomized, Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell with Marrow Transplantation from HLA Compatible Unrelated Donors BMT CTN PROTOCOL 0201 Version 8.0 Study Chairperson Claudio Anasetti, M.D. 1 Protocol Team Colleen Allen 2 Stephanie J. Lee, M.D. 8 Paolo Anderlini, M.D. 3 Susan Leitman, M.D. 9 William Bensinger, M.D. 1 Brent Logan, Ph.D. 6 Michael R. Bishop, M.D. 4 Phyllis Mitchell, M.S. 10 Shelly Carter, Sc.D. 2 Scott D. Rowley, M.D. 11 Dennis L. Confer, M.D. 5 Edmund K. Waller, M.D., Ph.D. 12 Mary Horowitz, M.D., M.S. 6 Daniel Weisdorf, M.D. 13 Chatchada Karanes, M.D. 7 John R. Wingard, M.D. 14 Roberta J. King, M.P.H. 5 Sponsored by the National Institutes of Health National Heart, Lung, and Blood Institute National Cancer Institute and the National Marrow Donor Program 1 Fred Hutchinson Cancer Research Center 7 City of Hope 2 The EMMES Corporation 8 Dana Farber Cancer Institute 3 M.D. Anderson Cancer Center 9 NIH Department of Transfusion Medicine 4 National Cancer Institute 10 National Heart, Lung, and Blood Institute 5 National Marrow Donor Program 11 Hackensack University Medical Center 6 Center for International Blood and Marrow 12 Emory University Hospital Transplant Research, Medical College of 13 University of Minnesota Wisconsin 14 University of Florida, Shands Hospital BMT CLINICAL TRIALS NETWORK Core Study Participants: Non-Core Study Participants: City of Hope National Medical Center Baylor College of Medicine City of Hope Samaritan Baylor University Medical Center Dana Farber/Partners Cancer Center CancerCare Manitoba Duke University Medical Center Centre Hospitalier L’hotel Dieu de Quebec Fred Hutchinson Cancer Research Center CHA Hôpital L’Enfant – Jésus Hackensack University Medical Center (PBMTC) Emory University Hospital Karmanos Cancer Institute (PBMTC) Hackensack Univ Medical Center (Adults) Oregon Health Sciences University (CWRU/PBMTC) Hamilton Health Sciences Schneider Children's Hospital (PBMTC) Hôpital Maisonneuve – Rosemont St. Louis Children’s Hospital (PBMTC) Indiana BMT at Beech Grove Stanford Hospital and Clinics Kansas City Cancer Centers UCSD Medical Center Karmanos Cancer Institute (Adults) University Hospitals of Cleveland (CWRU) Loyola University Medical Center University of Florida School of Medicine, Shands Hospital Mayo Clinic University of Michigan Medical Center McGill University University of Minnesota Ottawa General Hospital University of Nebraska Medical Center Queen Elizabeth II Health Sciences Centre University of Pennsylvania Cancer Center Roswell Park Cancer Institute University of Texas, MD Anderson Cancer Research Center Saskatoon Cancer Centre Utah BMT/Primary Children's Medical Center (PBMTC) Texas Transplant Institute Vanderbilt University (PBMTC) Tom Baker Cancer Centre Washington University of St. Louis (CWRU) University of Alabama at Birmingham University of Iowa Hospitals University of Maryland University of Oklahoma Health Sciences Center University of Pittsburgh University of Toronto/Princess Margaret Hospital Utah BMT/Univ of Utah Medical School (Adults) Virginia Commonwealth University Wake Forest University BMT CLINICAL TRIALS NETWORK PBSC vs. Marrow Randomized Trial – Protocol 0201 Version 8.0 dated September 15, 2006 PROTOCOL SYNOPSIS – BMT CTN PROTOCOL 0201 A Phase III Randomized, Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell with Marrow Transplantation from HLA Compatible Unrelated Donors Principal Investigator: Claudio Anasetti, M.D. Study Design: 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. Primary Objective: The primary objective is to compare two-year survival probabilities between patients in the two study arms using an intent-to-treat analysis. Secondary Objectives: Patients randomized to the two study arms and actually transplanted will be compared for the following endpoints (patients who do not receive a transplant will be excluded from the following analyses): survival, incidences of neutrophil and platelet engraftment, graft failure, acute graft-versus-host disease (GVHD), chronic GVHD, time off all immunosuppressive therapy, relapse, infections, adverse events, immune reconstitution, and quality of life. Donors in each arm of the study will be compared for time to return to baseline toxicity score, CBC and WBC differential values after donation and quality of life. Eligibility Criteria: Eligible patients are up to 66.00 years of age, have acute leukemia, myelodysplasia, chronic myeloid leukemia, or other myeloproliferative disorders, adequate organ function, a 6/6 or 5/6 HLA-A, B and DRB1 matched unrelated donor, and are able to give signed informed consent prior to enrollment. Donors must be 18 years of age, meet National Marrow Donor Program (NMDP) criteria for donor eligibility and give informed consent prior to enrollment. Treatment Description: Patients will receive one of four conditioning regimens as described in the protocol, at the discretion of the transplant physician. The GVHD prophylaxis regimen will be per institutional standard, but may not contain Phase I agents. The transplant physician must declare the conditioning and GVHD prophylaxis regimens prior to randomization to the PBSC versus marrow arm. Marrow cells will be collected from the donors using standard procedures. PBSC i BMT CLINICAL TRIALS NETWORK PBSC vs. Marrow Randomized Trial – Protocol 0201 Version 8.0 dated September 15, 2006 donors will receive G-CSF ~10mcg/kg/d x 5 days and cells will be collected by a single large volume apheresis on Day 5, or two smaller volume apheresis procedures on Days 5 and 6. Marrow or blood cells will not be T-depleted or frozen prior to transplantation. Accrual Objective: Patients who are candidates for transplantation of G-CSF–mobilized PBSC or marrow from HLA-compatible unrelated donors will be targeted for accrual. Approximately 275 patients will be accrued per study arm (total of 550 patients). Accrual Period: The estimated accrual period is three years. Study Duration: Patients and donors will be followed for two years for evaluation of the primary endpoint, with additional follow-up to three years after transplantation or donation for evaluation of certain secondary endpoints. ii BMT CLINICAL TRIALS NETWORK PBSC vs. Marrow Randomized Trial – Protocol 0201 Version 8.0 dated September 15, 2006 TABLE OF CONTENTS 1. BACKGROUND AND RATIONALE .................................................................................1-1 1.1. Rationale.................................................................................................................................1-1 1.2. Marrow Cell Dose Effect.......................................................................................................1-1 1.3. PBSC Characteristics ............................................................................................................1-2 1.4. Safety of G-CSF in Normal Donors .....................................................................................1-2 1.5. Results of Randomized Trials of PBSC versus Marrow from HLA-Identical Siblings ..1-3 1.5.1. Engraftment .............................................................................................................................1-3 1.5.2. Acute GVHD ...........................................................................................................................1-3 1.5.3. Chronic GVHD........................................................................................................................1-3 1.5.4. Survival and Relapse ...............................................................................................................1-4 1.6. Results of Phase II Studies of PBSC from Unrelated Donors............................................1-4 1.6.1. European Studies .....................................................................................................................1-4 1.6.2. Preliminary NMDP Phase II Data in Unrelated Donor PBSC Transplants .............................1-4 2. STUDY DESIGN....................................................................................................................2-1 2.1. Study Overview......................................................................................................................2-1 2.2. Hypothesis and Specific Objectives......................................................................................2-1 2.2.1. Primary Hypothesis .................................................................................................................2-1 2.2.2. Secondary Hypotheses.............................................................................................................2-1 2.2.3. Study Objectives......................................................................................................................2-2 2.3. Patient Eligibility for Randomization..................................................................................2-2 2.3.1. Patient Inclusion Criteria .........................................................................................................2-2 2.3.2. Patient Exclusion
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