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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:
ClinicalTrials.gov Identifier:
NCT00002792
First Posted: January 27, 2003
Last Update Posted: April 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00002792     History of Changes
Other Study ID Numbers: 1032.01
FHCRC-1032.01
NCI-H96-0929
CDR0000064859 ( Registry Identifier: PDQ )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: April 2, 2010
Last Verified: March 2010

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:
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases
Cyclophosphamide
Methotrexate
Tacrolimus
Cyclosporins
Cyclosporine
Busulfan
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Calcineurin Inhibitors
Antifungal Agents