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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


Phase 1/Phase 2
18 Years
65 Years
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

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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 CenterSeattle, Washington  98109
Seattle Cancer Care AllianceSeattle, Washington  98109