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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: | NCT00357565 |
RATIONALE: Giving chemotherapy, such as busulfan, fludarabine, and melphalan, before a donor umbilical cord blood stem cell transplant helps stop the growth of abnormal or cancer cells and prepares the patient's bone marrow for the 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 cyclosporine and mycophenolate mofetil may stop this from happening.
PURPOSE: This phase II trial is studying how well combination chemotherapy followed by a donor umbilical cord blood transplant works in treating infants with high-risk acute leukemia or myelodysplastic syndromes.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes |
Drug: busulfan Drug: cyclosporine Drug: filgrastim Drug: fludarabine phosphate Drug: melphalan Drug: mycophenolate mofetil Procedure: allogeneic hematopoietic stem cell transplantation Procedure: umbilical cord blood transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Hematopoietic Cell Transplantation in the Treatment of Infant Leukemia Using Double Umbilical Cord Transplantation |
Estimated Enrollment: | 20 |
Study Start Date: | December 2005 |
Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, nonrandomized study.
After completion of study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Ages Eligible for Study: | up to 2 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following hematological malignancies:
Acute myeloid leukemia in complete remission (CR) or early relapse (i.e., < 15% blasts in bone marrow) and meets 1 of the following criteria:
In first CR (CR1) with high-risk disease as evidenced by the following:
High-risk cytogenetics
Acute lymphoblastic leukemia in CR, as defined by hematological recovery AND < 5% blasts by light microscopy within the bone marrow with a cellularity of ≥ 15%, and meets 1 of the following criteria:
In CR1 with high-risk disease as evidenced by the following:
High-risk cytogenetics
MDS with < 10% blasts by a representative bone marrow aspirate morphology and meets 1 of the following criteria:
4-6/6 HLA-A, -B, -DRB1 matched unrelated donor available
Patients receive two partially HLA-matched units, if available
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 |
Study Chair: | Michael R. Verneris, MD | Masonic Cancer Center, University of Minnesota |
Responsible Party: | Masonic Cancer Center at University of Minnesota ( Michael R. Verneris ) |
Study ID Numbers: | CDR0000486954, UMN-2005LS075, UMN-MT2005-25, UMN-0511M77206 |
Study First Received: | July 26, 2006 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00357565 |
Health Authority: | Unspecified |
childhood acute myeloid leukemia in remission recurrent childhood acute myeloid leukemia secondary acute myeloid leukemia childhood acute lymphoblastic leukemia in remission previously treated myelodysplastic syndromes secondary myelodysplastic syndromes |
refractory anemia with excess blasts in transformation refractory anemia with excess blasts refractory anemia de novo myelodysplastic syndromes childhood myelodysplastic syndromes |
Melphalan Leukemia, Lymphoid Cyclosporine Precancerous Conditions Clotrimazole Refractory anemia Miconazole Leukemia, Myeloid, Acute Cyclosporins Leukemia Preleukemia Anemia, Refractory Mycophenolate mofetil Neoplasm Metastasis Acute myelocytic leukemia |
Myelodysplastic syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Myelodysplastic Syndromes Myelodysplasia Tioconazole Anemia Acute myelogenous leukemia Leukemia, Myeloid Fludarabine monophosphate Recurrence Busulfan Anemia, Refractory, with Excess of Blasts Fludarabine Bone Marrow Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Pathologic Processes Therapeutic Uses Syndrome Antifungal Agents Antirheumatic Agents Dermatologic Agents |