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Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00423826 |
RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer or abnormal 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 cells and help destroy any remaining cancer or abnormal 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 tacrolimus and mycophenolate mofetil before the transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well umbilical cord blood stem cell transplant works in treating patients with hematologic cancer or other disease.
Condition | Intervention |
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Cancer-Related Problem/Condition Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous/Nonmalignant Condition |
Drug: busulfan Drug: cytarabine Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: tacrolimus Procedure: allogeneic hematopoietic stem cell transplantation Procedure: total-body irradiation Procedure: umbilical cord blood transplantation |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Study of Double Cord Blood Stem Cell Transplantation in Patients With Hematologic Malignancies |
Estimated Enrollment: | 30 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | up to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Acute myeloid leukemia meeting the following criteria:
Meets 1 of the following criteria:
In first CR with 1 of the following high-risk features:
Myelodysplastic syndromes with 1 of the following International Prognostic Scoring System (IPSS) scores:
Chronic myelogenous leukemia meeting 1 of the following criteria:
Acute lymphoblastic leukemia meeting 1 of the following criteria:
In first CR with any of the following high-risk features:
Hodgkin's or non-Hodgkin's lymphoma meeting the following criteria:
Myeloma or plasma cell neoplasm meeting 1 of the following staging criteria:
Stage I-II at presentation
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201-1379 | |
Contact: Roland L. Chu, MD 313-745-5515 rchu@med.wayne.edu |
Study Chair: | Roland L. Chu, MD | Barbara Ann Karmanos Cancer Institute |
Study ID Numbers: | CDR0000518230, WSU-2006-059, WSU-112506MP2F |
Study First Received: | January 16, 2007 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00423826 |
Health Authority: | Unspecified |
accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia childhood chronic myelogenous leukemia relapsing chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission recurrent adult acute lymphoblastic leukemia childhood acute lymphoblastic leukemia in remission recurrent childhood acute lymphoblastic 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 |
adult acute minimally differentiated myeloid leukemia (M0) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute promyelocytic leukemia (M3) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) adult acute megakaryoblastic leukemia (M7) childhood acute myeloblastic leukemia without maturation (M1) childhood acute myeloblastic leukemia with maturation (M2) childhood acute promyelocytic leukemia (M3) childhood acute myelomonocytic leukemia (M4) childhood acute monoblastic leukemia (M5a) |
Blast Crisis Chronic myelogenous leukemia Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Tacrolimus Di Guglielmo's syndrome Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Lymphomatoid granulomatosis Preleukemia Hemorrhagic Disorders Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Mycophenolate mofetil |
Leukemia, Promyelocytic, Acute Neoplasm Metastasis Acute myeloid leukemia, adult Hodgkin Disease Chronic lymphocytic leukemia Myelodysplastic syndromes Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, B-cell, chronic Blood Coagulation Disorders Acute promyelocytic leukemia Acute myelogenous leukemia Leukemia, Myeloid |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Disease Antimetabolites, Antineoplastic Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Physiological Effects of Drugs Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Pathologic Processes Syndrome Therapeutic Uses Cardiovascular Diseases |