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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00322101 |
RATIONALE: Giving chemotherapy drugs, such as fludarabine, busulfan, and cyclophosphamide, and total-body irradiation before a donor peripheral stem cell transplant helps stop both the growth of cancer cells and the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known which chemotherapy regimen with or without total-body irradiation is more effective in treating patients with a myelodysplastic syndrome or acute myeloid leukemia.
PURPOSE: This randomized phase III trial is studying chemotherapy and total-body irradiation to see how well it works compared to high-dose chemotherapy in treating patients who are undergoing donor stem cell transplant for myelodysplastic syndromes or acute myeloid leukemia.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: busulfan Drug: cyclophosphamide Drug: fludarabine phosphate Procedure: allogeneic hematopoietic stem cell transplantation Procedure: total-body irradiation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Multi-Center Phase III Study Comparing Myeloablative to Nonmyeloablative Transplant Conditioning in Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia |
Estimated Enrollment: | 280 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I (nonmyeloablative regimen): Experimental
Patients receive fludarabine IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0. Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0. Patients also receive oral or IV cyclosporine two or three times daily on days -3 to 177 with taper (RD) or -3 to 177 (URD) and oral mycophenolate mofetil every 12 hours (RD) or every 8 hours (URD) on days 0-27 (RD) or days 0-96 with taper (URD).
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Drug: cyclophosphamide
Given IV over 1-2 hours
Drug: fludarabine phosphate
Given IV
Procedure: allogeneic hematopoietic stem cell transplantation
Patients undergo allogeneic hematopoietic stem cell transplantation on day 0
Procedure: total-body irradiation
Patients undergo low-dose total-body irradiation
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Arm II (myeloablative regimen): Experimental
Patients are assigned to 1 of 2 treatment regimens. Some patients receive regimen A comprising fludarabine IV and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2. Some patients receive regimen B comprising cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.
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Drug: busulfan
Given orally four times daily or IV over 3 hours
Drug: fludarabine phosphate
Given IV
Procedure: allogeneic hematopoietic stem cell transplantation
Patients undergo allogeneic hematopoietic stem cell transplantation on day 0
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a prospective, randomized, open-label, multicenter study. Patients are stratified according to transplant center (FHCRC vs other), diagnosis (myelodysplastic syndromes [MDS] vs acute myeloid leukemia), donor (related [RD] vs unrelated [URD]), etiology (primary vs treatment-related), and International Prognostic Scoring System (IPSS) category for MDS (intermediate-2 vs high-risk). Patients are randomized to 1 of 2 treatment arms.
Patients with a history of treated CNS leukemia receive 2 doses of prophylactic intrathecal chemotherapy comprising either methotrexate or cytarabine prior to conditioning and 6 additional doses after transplantation, beginning on day 32.
Arm II (myeloablative regimen): Patients are assigned to 1 of 2 treatment regimens.
Patients undergo PBSC infusion on day 0. Patients also receive tacrolimus IV continuously or orally twice a day on days -1 to 200 (with taper) and methotrexate IV on days 1, 3, 6, and 11.
After completion of study therapy, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study.
Ages Eligible for Study: | up to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Acute myeloid leukemia (AML) meeting 1 of the following criteria:
Chemotherapy required prior to hematopoietic cell transplantation (HCT)
Related (for patients 65 years of age and under) or unrelated donor (for patients 60 years of age and under) ≥ 12 years of age meeting the following criteria:
Genotypically or phenotypically matched by high-resolution HLA typing, including any of the following:
Class 1 single allele mismatch allowed
Available for peripheral blood stem cell mobilization with filgrastim (G-CSF) and leukaphereses
PATIENT CHARACTERISTICS:
No active non-hematological malignancies
No liver function abnormalities, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, Colorado | |
Rocky Mountain Cancer Centers - Denver Midtown | Recruiting |
Denver, Colorado, United States, 80218 | |
Contact: Peter McSweeney, MD 303-388-4876 | |
United States, Georgia | |
Winship Cancer Institute of Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Amelia Langston, MD 404-778-4189 amelia_langston@emoryhealthcare.org | |
United States, New York | |
New York Weill Cornell Cancer Center at Cornell University | Recruiting |
New York, New York, United States, 10021 | |
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848 | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232-6838 | |
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
United States, Utah | |
Huntsman Cancer Institute at University of Utah | Recruiting |
Salt Lake City, Utah, United States, 84112 | |
Contact: Clinical Trials Office - Huntsman Cancer Institute at Universi 801-581-4477 clinical.trials@hci.utah.edu | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Bart L. Scott, MD 206-667-1990 bscott@fhcrc.org | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109-1023 | |
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 | |
Veterans Affairs Medical Center - Seattle | Recruiting |
Seattle, Washington, United States, 98108 | |
Contact: William H. Schubach, MD 206-764-2265 | |
United States, Wisconsin | |
Medical College of Wisconsin Cancer Center | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C 414-805-4380 | |
Germany | |
Krankenhaus Dresden - Friedrichstadt | Recruiting |
Dresden, Germany, D-01008 | |
Contact: Contact Person 49-351-458-4186 |
Principal Investigator: | Bart L. Scott, MD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Bart L. Scott ) |
Study ID Numbers: | CDR0000471838, FHCRC-1992.00, NHLBI-K23-HL084054-01A1 |
Study First Received: | May 2, 2006 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00322101 |
Health Authority: | Unspecified |
de novo myelodysplastic syndromes previously treated myelodysplastic syndromes adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute myeloid leukemia |
recurrent childhood acute myeloid leukemia adult acute myeloid leukemia in remission childhood acute myeloid leukemia in remission secondary acute myeloid leukemia refractory cytopenia with multilineage dysplasia myelodysplastic/myeloproliferative disease, unclassifiable childhood myelodysplastic syndromes |
Myelodysplastic syndromes Precancerous Conditions Hematologic Diseases Myelodysplasia Myelodysplastic Syndromes Acute myelogenous leukemia Myeloproliferative Disorders Fludarabine monophosphate Cyclophosphamide Leukemia, Myeloid Leukemia, Myeloid, Acute Recurrence |
Myelodysplastic myeloproliferative disease Leukemia Preleukemia Busulfan Neoplasm Metastasis Fludarabine Acute myeloid leukemia, adult Congenital Abnormalities Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases Acute myelocytic leukemia |
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Pathologic Processes Syndrome Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |