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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00301912 |
RATIONALE: Drugs used in chemotherapy, such as busulfan and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell or bone marrow transplant may allow more chemotherapy to be given so that more cancer cells are killed. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Tacrolimus and methotrexate may stop this from happening.
PURPOSE: This phase II trial is studying how well giving busulfan together with fludarabine before donor stem cell transplant works in treating patients with hematologic cancer.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: busulfan Drug: filgrastim Drug: fludarabine phosphate Drug: methotrexate Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation |
Estimated Enrollment: | 36 |
Study Start Date: | January 2002 |
OBJECTIVES:
Primary
Secondary
OUTLINE:
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Ages Eligible for Study: | 16 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following hematopoietic disorders:
Chronic myelogenous leukemia (CML), meeting 1 of the following criteria:
Chronic phase disease failing imatinib mesylate therapy
Accelerated phase disease, meeting 1 of the following criteria:
Acute myeloid leukemia (AML), meeting 1 of the following criteria:
Myelodysplasia with < 20% blasts in bone marrow within 6 weeks of transplantation and meeting 1 of the following criteria:
Acute lymphocytic leukemia (ALL), meeting 1 of the following criteria:
Non-Hodgkin's lymphoma, meeting 1 of the following criteria:
Lymphoproliferative disease (e.g., chronic lymphocytic leukemia or Waldenstrom's macroglobulinemia), meeting 1 of the following criteria:
Multiple myeloma, meeting 1 of the following criteria:
Advanced myeloproliferative disease, meeting 1 of the following criteria:
HLA-matched unrelated donor available
PATIENT CHARACTERISTICS:
Hepatitis C or active hepatitis B (HBV) allowed provided a liver biopsy is performed and ≤ grade 2 inflammation is present
PRIOR CONCURRENT THERAPY:
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 |
Study Chair: | Thomas G. Martin, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000463168, UCSF-02257, UCSF-2214, UCSF-H24045-22163-04 |
Study First Received: | March 9, 2006 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00301912 |
Health Authority: | Unspecified |
chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia adult acute myeloid leukemia in remission 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 secondary acute myeloid leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes atypical chronic myeloid leukemia |
myelodysplastic/myeloproliferative disease, unclassifiable adult acute lymphoblastic leukemia in remission recurrent adult lymphoblastic lymphoma anemia refractory chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia Waldenstrom macroglobulinemia stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma polycythemia vera essential thrombocythemia extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma |
Polycythemia Blast Crisis Chronic myelogenous leukemia Chronic myelomonocytic leukemia Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Tacrolimus Lymphoma, large-cell, immunoblastic Preleukemia Hemorrhagic Disorders Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Hemorrhagic thrombocythemia Neoplasm Metastasis Methotrexate |
Thrombocythemia, Hemorrhagic Acute myeloid leukemia, adult Essential thrombocytosis Chronic lymphocytic leukemia Myelodysplastic syndromes Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, B-cell, chronic Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Blood Coagulation Disorders Acute myelogenous leukemia Myeloproliferative Disorders |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Pathologic Processes Syndrome Therapeutic Uses Abortifacient Agents Cardiovascular Diseases Alkylating Agents Dermatologic Agents |
Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Disease Immune System Diseases Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |