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

Primary Purpose

Chronic Myeloproliferative Disorders, Leukemia, Myelodysplastic/Myeloproliferative Diseases

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
busulfan
cyclophosphamide
cyclosporine
methotrexate
tacrolimus
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloproliferative Disorders focused on measuring polycythemia vera, chronic idiopathic myelofibrosis, essential thrombocythemia, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
March 31, 2010
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002792
Brief Title
Combination Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorders
Official Title
ALLOGENEIC MARROW OR PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR AGNOGENIC MYELOID METAPLASIA WITH MYELOFIBROSIS
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
June 1996 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
April 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloproliferative Disorders, Leukemia, Myelodysplastic/Myeloproliferative Diseases
Keywords
polycythemia vera, chronic idiopathic myelofibrosis, essential thrombocythemia, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
busulfan
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
cyclosporine
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Intervention Type
Procedure
Intervention Name(s)
allogeneic bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Joachim Deeg, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9326205
Citation
Anderson JE, Sale G, Appelbaum FR, Chauncey TR, Storb R. Allogeneic marrow transplantation for primary myelofibrosis and myelofibrosis secondary to polycythaemia vera or essential thrombocytosis. Br J Haematol. 1997 Sep;98(4):1010-6. doi: 10.1046/j.1365-2141.1997.3083125.x.
Results Reference
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Combination Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorders

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