Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder
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Purpose
RATIONALE: Giving chemotherapy drugs before a donor peripheral blood stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop 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. Giving colony-stimulating factors, such as G-CSF, to the donor helps the stem cells move from the bone marrow to the blood so they can be collected and stored.
PURPOSE: This phase I/II trial is studying how well donor peripheral stem cell transplant works in treating patients with myelodysplastic syndrome, acute myeloid leukemia, or myeloproliferative disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: methotrexate Procedure: in vitro-treated peripheral blood stem cell transplantation |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study of Immunologically Engineered rhG-CSF Mobilized Peripheral Blood Stem Cells (PBSC) for Allogeneic Transplant From HLA Identical, Related Donors for Treatment of Myeloid Malignancies |
- Incidence of grade II, III, and IV graft-versus-host disease [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2002 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the incidence of grades II, III, and IV graft-vs-host disease (GVHD) in patients with myelodysplastic syndromes (MDS), acute myeloid leukemia transformed from MDS, or myeloproliferative disorders treated with immunologically engineered, filgrastim (G-CSF)-mobilized, allogeneic peripheral blood stem cell transplantation.
- Determine the incidence of graft failure, relapse, and transplant-related mortality by day 100 in patients treated with this regimen.
- Determine the incidence of chronic GVHD, in terms of number and duration of immunosuppressant therapies, in patients treated with this regimen.
- Determine the feasibility of partial T-cell depletion in G-CSF-mobilized peripheral blood stem cells.
OUTLINE: Patients receive conditioning with oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2. Immunologically engineered, filgrastim (G-CSF)-mobilized, allogeneic peripheral blood stem cells are infused on day 0.
Patients receive graft-vs-host disease prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1-4 hours (orally twice daily when tolerated) on days -1 to 80 and then gradually tapered over 5 months beginning on day 81.
Patients are followed regularly through day 100 and then at 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
- Myelodysplastic syndromes (MDS) that has advanced beyond refractory anemia (RA)
- RA with excess blasts (RAEB) (greater than 5% blasts)
- RAEB in transformation (greater than 20% but less than 30% blasts)
- Acute myeloid leukemia (greater than 30% blasts) that evolved from MDS
- Myeloproliferative disorder, including chronic myelomonocytic leukemia, agnogenic myeloid metaplasia, polycythemia vera, or essential thrombosis
- No chronic myelogenous leukemia with or without excess (greater than 5%) blasts
- Must have an HLA-identical, related donor
PATIENT CHARACTERISTICS:
Age
- 18 to 65
Performance status
- Not specified
Life expectancy
- At least 6 months
Hematopoietic
- Not specified
Hepatic
- Bilirubin less than 2 times upper limit of normal (ULN)*
- SGOT/SGPT less than 2 times ULN* NOTE: * Unless due to malignancy
Renal
- Creatinine no greater than 2.0 mg/dL OR
- Glomerular filtration rate at least 60 mL/min
Cardiovascular
- Cardiac ejection fraction at least 45%
Pulmonary
- DLCO at least 60% of predicted
Other
- HIV negative
- Human antimouse antibody negative
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other medical condition that would preclude study participation
- No hypersensitivity to cyclosporine
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior marrow transplantation
- No concurrent growth factors for 21 days after study transplantation
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98104 | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109-1023 | |
| Study Chair: | Ann E. Woolfrey, MD | Fred Hutchinson Cancer Research Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Ann E. Woolfrey, Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00049634 History of Changes |
| Other Study ID Numbers: | 1628.00, FHCRC-1628.00, NCI-H02-0099, CDR0000258137 |
| Study First Received: | November 12, 2002 |
| Last Updated: | September 14, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
chronic myelomonocytic leukemia de novo myelodysplastic syndromes essential thrombocythemia polycythemia vera previously treated myelodysplastic syndromes refractory anemia with excess blasts refractory anemia with excess blasts in transformation |
secondary acute myeloid leukemia secondary myelodysplastic syndromes chronic eosinophilic leukemia chronic neutrophilic leukemia atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Busulfan Cyclophosphamide Cyclosporins |
Cyclosporine Methotrexate Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Antirheumatic Agents Enzyme Inhibitors Antifungal Agents |
ClinicalTrials.gov processed this record on June 17, 2013