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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002792
• Other study ID #: 1032.01
• Secondary ID: FHCRC-1032.01NCI
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: March 31, 2010
• Start date: June 1996
• Est. completion date: April 2003

Study information

• Verified date: March 2010
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2003
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Leukemia
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Diseases
• Myeloproliferative Disorders

Intervention

Drug:
• busulfan

• cyclophosphamide

• cyclosporine

• methotrexate

• tacrolimus

Procedure:
• allogeneic bone marrow transplantation

• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation