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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00346359 |
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of abnormal and cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining abnormal or cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin, tacrolimus, and methotrexate before or after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving fludarabine together with busulfan followed by donor peripheral stem cell transplant and antithymocyte globulin, tacrolimus, and methotrexate works in treating patients with myeloid cancer.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Biological: anti-thymocyte globulin Drug: busulfan Drug: fludarabine phosphate Drug: methotrexate Drug: tacrolimus Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Conditioning For Hematopoietic Cell Transplantation With Fludarabine Plus Targeted IV Busulfan and GVHD Prophylaxis With Thymoglobulin, Tacrolimus and Methotrexate in Patients With Myeloid Malignancies |
Estimated Enrollment: | 40 |
Study Start Date: | March 2006 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE:
After completion of study treatment, patients are followed annually.
PROJECTED ACCRUAL: A total of 40 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 myeloid malignancies:
Chronic myelogenous leukemia meeting 1 of the following criteria:
Acute myeloid leukemia meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109-1024 |
Study Chair: | Paul V. O'Donnell, MD, PhD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | CDR0000488969, FHCRC-2041.00, GEMZYME-FHCRC-2041.00 |
Study First Received: | June 28, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00346359 History of Changes |
Health Authority: | United States: Federal Government |
graft versus host disease chronic phase chronic myelogenous leukemia childhood chronic myelogenous leukemia blastic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia adult acute myeloid leukemia in remission recurrent adult acute myeloid leukemia childhood acute myeloid leukemia in remission recurrent childhood acute myeloid leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes atypical chronic myeloid leukemia |
chronic myelomonocytic leukemia juvenile myelomonocytic leukemia myelodysplastic/myeloproliferative disease, unclassifiable secondary acute myeloid leukemia chronic eosinophilic leukemia chronic idiopathic myelofibrosis chronic neutrophilic leukemia 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) childhood myelodysplastic syndromes |
Antimetabolites Chronic Myelomonocytic Leukemia Blast Crisis Immunologic Factors Precancerous Conditions Tacrolimus Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid, Acute Graft Versus Host Disease Leukemia Acute Myelocytic Leukemia Preleukemia Acute Myeloid Leukemia, Adult Chronic Myeloproliferative Disorders Neoplasm Metastasis |
Methotrexate Congenital Abnormalities Alkylating Agents Myelodysplastic Myeloproliferative Disease Myelofibrosis Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Myeloproliferative Disorders Juvenile Myelomonocytic Leukemia Fludarabine monophosphate Leukemia, Myelomonocytic, Juvenile Leukemia, Myeloid Folic Acid Antagonists |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Precancerous Conditions Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Tacrolimus Leukemia Preleukemia Pathologic Processes Therapeutic Uses Syndrome Abortifacient Agents |
Methotrexate Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Disease Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Enzyme Inhibitors Fludarabine monophosphate Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents |