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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00002792
First received: November 1, 1999
Last updated: March 31, 2010
Last verified: March 2010
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow or peripheral stem cell transplantation with chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus either bone marrow or peripheral stem cell transplantation in treating patients with myeloproliferative disorders.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Leukemia
Myelodysplastic/Myeloproliferative Diseases
 Drug: busulfan
Drug: cyclophosphamide
Drug: cyclosporine
Drug: methotrexate
Drug: tacrolimus
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: ALLOGENEIC MARROW OR PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR AGNOGENIC MYELOID METAPLASIA WITH MYELOFIBROSIS

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Estimated Enrollment: 20
Study Start Date: June 1996
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Detailed 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 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.

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002792

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
Study Chair: H. Joachim Deeg, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00002792     History of Changes
Other Study ID Numbers: 1032.01, FHCRC-1032.01, NCI-H96-0929, CDR0000064859
Study First Received: November 1, 1999
Last Updated: March 31, 2010
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
polycythemia vera
chronic idiopathic myelofibrosis
essential thrombocythemia
atypical chronic myeloid leukemia
myelodysplastic/myeloproliferative disease, unclassifiable

Additional relevant MeSH terms:
Primary Myelofibrosis
Leukemia
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases
Neoplasms by Histologic Type
Neoplasms
Busulfan
Cyclophosphamide
Cyclosporins
Cyclosporine
Methotrexate
Tacrolimus
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
Anti-Infective Agents
Dermatologic Agents
Abortifacient Agents, Nonsteroidal

ClinicalTrials.gov processed this record on May 22, 2013