Phase
Condition
Leukemia
Red Blood Cell Disorders
White Cell Disorders
Treatment
N/AClinical Study ID
Ages < 66 All Genders
Study Summary
Eligibility Criteria
Inclusion
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, secondremission, third or subsequent remission, or not in remission
- Chronic myelogenous leukemia at the following stages: chronic phase, acceleratedphase, or blast phase
- Myelodysplastic syndromes (MDS) at the following stages: refractory anemia; refractoryanemia with ringed sideroblasts; refractory cytopenia with multilineage dysplasia;refractory cytopenia with multilineage dysplasia and ringed sideroblasts; refractoryanemia with excess blasts-1 (5-10% blasts); refractory anemia with excess blasts-2 (10-20% blasts); myelodysplastic syndrome, unclassified; or MDS associated withisolated del (5q)
- Myeloproliferative diseases: chronic myelomonocytic leukemia; agnogenic myeloidmetaplasia with myelofibrosis (idiopathic myelofibrosis); juvenile myelomonocyticleukemia
- Therapy-related acute myelogenous leukemia (AML) or MDS with prior malignancy that hasbeen 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
Exclusion
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 willbe eligible; the prior autologous transplant must have been performed for the primarymalignancy (such as lymphoma) and must have occurred 12 or more months prior toenrollment
- Lymphoma (11% of 2001 NMDP transplants), other malignant disorders (6%), andnon-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 mismatchat HLA-C
- Typing is by DNA techniques: intermediate resolution for A, B, and C, and highresolution 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 ofa 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 ashemoglobin electrophoresis
- Receiving experimental therapy or investigational agents
Study Design
Study Description
Connect with a study center
Tom Baker Cancer Centre, Calgary
Calgary, Alberta T2N 4N2
CanadaSite Not Available
Vancouver General Hospital
Vancouver, British Columbia V5Z1M9
CanadaSite Not Available
Hamilton Health Sciences - McMaster Site
Hamilton, Ontario
CanadaSite Not Available
Ottawa Hospital
Ottawa, Ontario
CanadaSite Not Available
University of Toronto, Princess Margaret Hospital
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Queen Elizabeth II Health Sciences Centre - Halifax
Halifax,
CanadaSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
City of Hope National Medical Center
Duarte, California 91010
United StatesSite Not Available
UCSD Cancer Center
La Jolla, California 92093-0960
United StatesSite Not Available
University of California, San Francisco
San Francisco, California 94143
United StatesSite Not Available
Stanford Hospital and Clinics
Stanford, California 94305
United StatesSite Not Available
University of Florida College of Medicine (Shands)
Gainesville, Florida 32610-100277
United StatesSite Not Available
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Loyola University
Maywood, Illinois 60153
United StatesSite Not Available
Indiana BMT at Beech Grove
Beech Grove, Indiana 46107
United StatesSite Not Available
IBMT (Indiana Blood and Marrow Transplant) at St Francis Franciscan Health
Indianapolis, Indiana 46237
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
University of Kansas Hospital
Kansas City, Kansas 66160
United StatesSite Not Available
University of Maryland
Baltimore, Maryland 21228
United StatesSite Not Available
DFCI/Brigham & Women's
Boston, Massachusetts 02114
United StatesSite Not Available
University of Michigan Medical Center
Ann Arbor, Michigan 48109-0942
United StatesSite Not Available
University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
Mayo Clinic Cancer Center
Rochester, Minnesota 55905
United StatesSite Not Available
Washington University/Barnes Jewish Hospital
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University/St. Louis Children's Hospital
Saint Louis, Missouri 63110
United StatesSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 68198-3330
United StatesSite Not Available
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Roswell Park Cancer Institute
Buffalo, New York 14263-0001
United StatesSite Not Available
Cohen Children's Hospital
New Hyde Park, New York 11040
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27705
United StatesSite Not Available
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157-1082
United StatesSite Not Available
Ohio State/Arthur G. James Cancer Hospital
Columbus, Ohio 43210
United StatesSite Not Available
University of Oklahoma Medical Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Oregon Health & Science University (Peds)
Portland, Oregon 97239-3098
United StatesSite Not Available
Oregon Health Sciences University
Portland, Oregon 97239
United StatesSite Not Available
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
Vanderbilt University
Nashville, Tennessee 37232-6838
United StatesSite Not Available
Baylor University Medical Center
Dallas, Texas 77030
United StatesSite Not Available
Baylor College of Medicine/The Methodist Hospital
Houston, Texas 77030-2399
United StatesSite Not Available
University of Texas/MD Anderson CRC
Houston, Texas 77030-4009
United StatesSite Not Available
Texas Transplant Institute
San Antonio, Texas 78229
United StatesSite Not Available
Utah BMT/Primary Children's Medical Center
Salt Lake City, Utah 84112
United StatesSite Not Available
Utah BMT/University of Utah Medical School
Salt Lake City, Utah 84132
United StatesSite Not Available
Virginia Commonwealth University MCV Hospitals
Richmond, Virginia 23298-0037
United StatesSite Not Available
Fred Hutchinson Cancer Research Center
Seattle, Washington 98104
United StatesSite Not Available
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