Search / Trial NCT00002792

Combination Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorders

Launched by FRED HUTCHINSON CANCER CENTER · Jan 26, 2003

Trial Information

Current as of November 03, 2024

Completed

Keywords

Polycythemia Vera Chronic Idiopathic Myelofibrosis Essential Thrombocythemia Atypical Chronic Myeloid Leukemia Myelodysplastic/Myeloproliferative Disease, Unclassifiable

Description

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...

Gender

ALL

Eligibility 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

About Fred Hutchinson Cancer Center

Fred Hutchinson Cancer Center is a leading nonprofit research institution dedicated to the pursuit of innovative cancer treatments and prevention strategies. Established in Seattle, Washington, the center is renowned for its pioneering work in hematopoietic cell transplantation and its commitment to advancing cancer research through collaborative clinical trials. By integrating cutting-edge science with compassionate patient care, Fred Hutchinson Cancer Center aims to improve outcomes for patients while fostering a multidisciplinary approach to tackling complex cancer challenges. With a strong emphasis on translating research findings into clinical applications, the center is at the forefront of developing novel therapies that offer hope to patients worldwide.

Locations

Seattle, Washington, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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