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ALLOGENEIC MARROW OR PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR AGNOGENIC MYELOID METAPLASIA WITH MYELOFIBROSIS


Phase 2
N/A
65 Years
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Leukemia, Myelodysplastic/Myeloproliferative Diseases

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Trial Information

ALLOGENEIC MARROW OR PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR AGNOGENIC MYELOID METAPLASIA WITH MYELOFIBROSIS


OBJECTIVES:

- Assess disease free survival in patients with idiopathic myelofibrosis treated with a
preparative busulfan/cyclophosphamide regimen followed by allogeneic bone marrow or
peripheral blood stem cell transplantation.

- Determine the risk of primary graft failure in these patients.

OUTLINE: Patients receive a preparative regimen consisting of oral busulfan every 6 hours on
days -7 through -4 and cyclophosphamide on days -3 and -2. Patients then receive allogeneic
bone marrow or peripheral blood stem cells on day 0. Patients registered on protocol
FHCRC-1106.00 randomized to stem cell transplant receive unmodified G-CSF-mobilized stem
cells from an HLA-identical donor.

Patients receive cyclosporine/methotrexate or tacrolimus/methotrexate as prophylaxis for
graft-versus-host disease (GVHD). Patients receiving marrow from unrelated donors are
eligible for appropriate GVHD prophylaxis studies.

Patients are followed at 6 and 12 months after transplant.

PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study over
approximately 3.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Idiopathic myelofibrosis (IMF) with at least 1 poor prognosis characteristic,
including but not limited to:

- Hemoglobin less than 10 g/dL

- Platelet count less than 100,000/mm^3

- Hepatomegaly (i.e., palpable liver edge 5 cm below costal margin)

- Clinical requirement for splenectomy

- Other myeloproliferative disorders in an IMF like myelofibrotic state eligible

- No evidence of leukemic progression, e.g.:

- Greater than 15% peripheral blood blasts

- Fever or bone pain of unknown origin

- Rapidly progressing splenomegaly

- No other causes for myelofibrosis, such as:

- Collagen vascular disorder

- Lymphoma

- Granulomatous infection

- Metastatic carcinoma

- Hairy cell leukemia

- Myelodysplastic syndrome

- No active central nervous system disease

- One of the following donor/patient pairings is required:

- Donor status:

- Genotypic or phenotypic HLA-matched relative

- Maximum patient age of 65

- One antigen HLA-mismatched relative, HLA-matched unrelated donor, or one
antigen HLA-mismatched unrelated donor

- Maximum patient age of 55

- Transplant on this protocol allowed for patients registered on protocol FHCRC-1106.00

PATIENT CHARACTERISTICS:

Age:

- 65 and under

Performance status:

- Not specified

Hematopoietic:

- See Disease Characteristics

Hepatic:

- Bilirubin no greater than 2 times normal

- SGPT no greater than 4 times normal

Renal:

- Creatinine no greater than two times normal OR

- Creatinine clearance at least 50%

Cardiovascular:

- Ejection fraction at least 50%

- Cardiac evaluation required if signs or symptoms of coronary artery disease or
congestive heart failure

Other:

- HIV negative

- No active infection

- Patients excluded from this protocol are referred to protocol FHCRC-179.05

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

H. Joachim Deeg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1032.01

NCT ID:

NCT00002792

Start Date:

June 1996

Completion Date:

April 2003

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Myelodysplastic/Myeloproliferative Diseases
  • polycythemia vera
  • chronic idiopathic myelofibrosis
  • essential thrombocythemia
  • atypical chronic myeloid leukemia
  • myelodysplastic/myeloproliferative disease, unclassifiable
  • Primary Myelofibrosis
  • Leukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109