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
18 Years
65 Years
Both
Chronic Myeloproliferative Disorders, Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of grade II, III, and IV graft-versus-host disease
Safety Issue:
No
Principal Investigator
Ann E. Woolfrey, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
1628.00
NCT ID:
NCT00049634
Start Date:
January 2002
Completion Date:
Related Keywords:
- Chronic Myeloproliferative Disorders
- Leukemia
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Diseases
- 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
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
