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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00796068 |
RATIONALE: Giving low doses of chemotherapy, such as treosulfan and fludarabine, together with total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop 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 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 phase II trial is studying how well giving treosulfan together with fludarabine and total-body irradiation works in treating patients with hematological cancer who are undergoing donor umbilical cord blood transplant.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: treosulfan Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure: umbilical cord blood transplantation Radiation: total-body irradiation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Treosulfan Based Preparative Regimen |
Estimated Enrollment: | 28 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to risk of graft failure (low vs high ).
After completion of transplantation, patients are followed periodically until day 100, at 6 months and 1 year, and then annually thereafter.
Ages Eligible for Study: | up to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following:
Acute myeloid leukemia (AML) or acute lymphoblastic leukemia
Myelodysplastic syndromes (MDS)
Any 2001 WHO classification subtype, including the following:
Juvenile myelomonocytic leukemia (JMML)
Chronic myelogenous leukemia
Meets one of the following criteria:
At low risk for graft failure, as defined by any of the following:
At high risk for graft failure, as defined by any of the following:
Matched (≥ 4/6 HLA-A, B, and DRB1 loci) unrelated umbilical cord blood (UCB) donor available
PATIENT CHARACTERISTICS:
Creatinine ≤ 2.0 mg/dL (adults )
None of the following hepatic conditions*:
PRIOR CONCURRENT THERAPY:
United States, Oregon | |
Knight Cancer Institute at Oregon Health and Science University | Recruiting |
Portland, Oregon, United States, 97239-3098 | |
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Colleen Delaney, MD, MSC 206-667-1385 sdelaney@fhcrc.org |
Principal Investigator: | Colleen Delaney, MD, MSC | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Colleen Delaney ) |
Study ID Numbers: | CDR0000626175, FHCRC-2275.00, IR-6800 |
Study First Received: | November 21, 2008 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00796068 History of Changes |
Health Authority: | Unspecified |
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 recurrent adult acute myeloid leukemia childhood acute myeloid leukemia in remission recurrent childhood acute myeloid leukemia childhood myelodysplastic syndromes de novo myelodysplastic syndromes previously treated myelodysplastic syndromes refractory anemia refractory anemia with excess blasts in transformation refractory anemia with excess blasts refractory anemia with ringed sideroblasts |
myelodysplastic/myeloproliferative disease, unclassifiable adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) childhood acute myeloblastic leukemia without maturation (M1) childhood acute myeloblastic leukemia with maturation (M2) childhood acute myelomonocytic leukemia (M4) childhood acute monoblastic leukemia (M5a) childhood acute monocytic leukemia (M5b) secondary myelodysplastic syndromes refractory cytopenia with multilineage dysplasia |
Chronic Myelomonocytic Leukemia Cyclosporine Miconazole Cyclosporins Refractory Anemia Preleukemia Acute Myelocytic Leukemia Anemia, Refractory Acute Myeloid Leukemia, Adult Neoplasm Metastasis Mycophenolate mofetil Myelodysplastic Myeloproliferative Disease Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myelomonocytic, Chronic |
Myeloproliferative Disorders Juvenile Myelomonocytic Leukemia Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Fludarabine Antimetabolites Leukemia, Monocytic, Acute Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Precancerous Conditions Immunologic Factors Clotrimazole Acute Myelomonocytic Leukemia Leukemia, Myeloid, Chronic-Phase |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Precancerous Conditions Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclosporins Leukemia Preleukemia Pathologic Processes Therapeutic Uses Antifungal Agents |
Syndrome Mycophenolate mofetil Alkylating Agents Dermatologic Agents Disease Neoplasms by Histologic Type Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Enzyme Inhibitors Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Neoplasms Antineoplastic Agents, Alkylating |