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Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00290641 |
RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, and radiation therapy before a donor umbilical cord blood stem cell transplant helps stop the growth of 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 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 cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well giving chemotherapy together with total-body irradiation followed by donor umbilical cord blood transplant, cyclosporine, and mycophenolate mofetil works in treating patients with hematologic cancer.
Condition | Intervention |
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Chronic Myeloproliferative Disorders Leukemia Lymphoma Myelodysplastic Syndromes |
Drug: cyclophosphamide Drug: cyclosporine Drug: filgrastim Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: graft-versus-tumor induction therapy Procedure: radiation therapy Procedure: umbilical cord blood transplantation |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Cyclophosphamide/Fludarabine/Total Body Irradiation Preparative Regimen for Patients With Hematological Malignancy Receiving Unrelated Donor Umbilical Cord Blood Transplantation |
Study Start Date: | April 2001 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to HLA disparity (0-1 vs 2) and number of graft units (1 vs 2).
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Ages Eligible for Study: | up to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of a hematologic malignancy of 1 of the following types:
Acute myeloid leukemia (AML), meeting the following criteria:
In complete remission (CR) by morphology (< 5% blasts in the bone marrow), as defined by 1 of the following:
In first CR (CR1) and meets ≥ 1 of the following high-risk criteria:
No morphologic relapse
Acute lymphocytic leukemia (ALL), meeting the following criteria:
In CR, as defined by 1 of the following:
In CR1 and meets ≥ 1 of the following high-risk criteria:
Advanced myelodysplasia (blasts < 10% [otherwise need AML induction pre-transplant]), meeting ≥ 1 of the following criteria:
Non-Hodgkin's lymphoma (NHL), meeting the following criteria:
One of the following histologic subtypes:
Mantle cell NHL
High-grade NHL
Donor available, meeting the following criteria:
4-6/6 HLA-A, -B, and -DRB1, matched unrelated donor by molecular techniques
PATIENT CHARACTERISTICS:
Creatinine ≤ 2.0 mg/dL (for adults) OR creatinine clearance > 40 mL/min (for children)
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
University of Minnesota Cancer Center | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Claudio G. Brunstein, MD, PhD | Masonic Cancer Center, University of Minnesota |
Study ID Numbers: | CDR0000450887, UMN-2000LS068, UMN-MT2000-25, UMN-0010M68201 |
Study First Received: | February 9, 2006 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00290641 |
Health Authority: | United States: Federal Government |
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) childhood acute myeloid leukemia in remission secondary acute myeloid leukemia accelerated phase chronic myelogenous leukemia childhood chronic myelogenous leukemia chronic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia refractory anemia with excess blasts de novo myelodysplastic syndromes previously treated myelodysplastic syndromes |
secondary myelodysplastic syndromes noncontiguous stage II adult Burkitt lymphoma recurrent adult Burkitt lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma noncontiguous stage II adult diffuse large cell lymphoma recurrent adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma recurrent adult diffuse mixed cell lymphoma stage III adult diffuse mixed cell lymphoma stage IV adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma recurrent adult diffuse small cleaved cell lymphoma |
Blast Crisis Cyclosporine Chronic myelogenous leukemia Refractory anemia Miconazole Lymphoma, Mantle-Cell Mycophenolic Acid Lymphoma, small cleaved-cell, diffuse Cyclosporins Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Preleukemia Anemia, Refractory Mycophenolate mofetil Neoplasm Metastasis |
Acute myeloid leukemia, adult Myelodysplastic syndromes Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Myeloproliferative Disorders Acute myelogenous leukemia Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Fludarabine Lymphoma, Non-Hodgkin Leukemia, Lymphoid Hematologic Neoplasms Precancerous Conditions |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Pathologic Processes Antifungal Agents Syndrome Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Dermatologic Agents Alkylating Agents |