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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: | NCT00301951 |
RATIONALE: Giving chemotherapy before a donor umbilical cord blood 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving chemotherapy, such as fludarabine and busulfan, and antithymocyte globulin before transplant and tacrolimus and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well giving low-dose fludarabine and busulfan together with anti-thymocyte globulin, followed by donor umbilical cord blood transplant works in treating patients with advanced hematologic cancer.
Condition | Intervention |
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Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Biological: anti-thymocyte globulin Biological: sargramostim Drug: busulfan Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: tacrolimus Procedure: umbilical cord blood transplantation |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Pilot Study of Reduced-Intensity Umbilical Cord Blood Transplantation in Adult Patients With Advanced Hematopoietic Malignancies |
Estimated Enrollment: | 10 |
Study Start Date: | December 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following advanced hematologic malignancies:
Acute myeloid leukemia (AML) meeting the following criteria:
Meets any of the following criteria:
Myelodysplastic syndromes (MDS) meeting the following criteria:
Must have high-risk features, including any of the following:
Acute lymphoblastic leukemia meeting the following criteria:
Meets any of the following criteria:
Chronic myelogenous leukemia (CML) meeting 1 of the following criteria:
Accelerated phase CML meeting 1 of the following criteria:
Multiple myeloma meeting the following criteria:
Meets any of the following criteria:
Lymphoma
The following subtypes are eligible:
Low-grade non-Hodgkin's lymphoma meeting 1 of the following criteria:
Chronic lymphocytic leukemia
Meets 1 of the following criteria:
Under age 55 and deemed ineligible for conventional high-dose chemotherapy, as indicated by any of the following:
Umbilical cord blood donor available
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Hepatitis C or active hepatitis B virus (HBV) allowed if ≤ grade 2 fibrosis and/or inflammation by liver biopsy
PRIOR CONCURRENT THERAPY:
United States, California | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94143-0324 |
Principal Investigator: | Thomas G. Martin, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000465362, UCSF-04253, UCSF-2407, UCSF-H24045-25271-02 |
Study First Received: | March 9, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00301951 History of Changes |
Health Authority: | United States: Federal Government |
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) accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission angioimmunoblastic T-cell lymphoma blastic phase chronic myelogenous leukemia chronic myelomonocytic leukemia chronic phase chronic myelogenous leukemia de novo myelodysplastic syndromes extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue anaplastic large cell lymphoma |
nodal marginal zone B-cell lymphoma previously treated myelodysplastic syndromes recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent adult T-cell leukemia/lymphoma recurrent adult Hodgkin lymphoma recurrent adult diffuse large cell lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent mycosis fungoides/Sezary syndrome recurrent small lymphocytic lymphoma |
Chronic Myelomonocytic Leukemia Blast Crisis Lymphoma, Mantle-Cell Mantle Cell Lymphoma Tacrolimus Follicular Lymphoma Mycoses Acute Myelocytic Leukemia Preleukemia Hemorrhagic Disorders Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Mycophenolate mofetil Neoplasm Metastasis Lymphoma, Large-Cell, Anaplastic |
Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Leukemia, Myeloid Multiple Myeloma B-cell Lymphomas Leukemia, Myeloid, Accelerated Phase Leukemia, T-Cell Fludarabine Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Hematologic Neoplasms Precancerous Conditions Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Tacrolimus Hemostatic Disorders Leukemia Preleukemia Neoplasms by Site |
Hemorrhagic Disorders Pathologic Processes Therapeutic Uses Syndrome Mycophenolate mofetil Cardiovascular Diseases Alkylating Agents Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type Disease Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Vascular Diseases |