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Autologous Peripheral Blood Stem Cell Mobilization and Transplantation for Myelofibrosis


Phase 2
N/A
75 Years
Not Enrolling
Both
Chronic Myeloproliferative Disorders

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Trial Information

Autologous Peripheral Blood Stem Cell Mobilization and Transplantation for Myelofibrosis


OBJECTIVES: I. Determine the ability of myeloablative chemotherapy followed by peripheral
blood stem cell (PBSC) transplantation to restore effective marrow hematopoieses in patients
with advanced idiopathic myelofibrosis or myelofibrosis secondary to other
myeloproliferative disorders. II. Determine the ability of this regimen to palliate symptoms
and prolong survival in these patients. III. Determine if there is evidence of clonal
hematopoieses before PBSC mobilization, in the PBSC product, and after transplantation in
these patients. IV. Correlate the properties of the peripheral blood before mobilization and
the PBSC product with engraftment in these patients. V. Correlate the markers of
angiogenesis with clinical parameters in these patients.

OUTLINE: Patients with evidence of leukemic progression receive cytoreduction therapy
consisting of idarubicin IV on days 1-3 and cytarabine IV continuously over days 1-7
followed by filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover and
leukapheresis is completed. Patients undergo leukapheresis beginning when blood counts
recover and continuing until the target number of cells are collected. Patients with no
evidence of leukemic progression receive filgrastim SC daily until leukapheresis is
completed. Patients undergo leukapheresis beginning on day 4 and continuing until the target
number of cells are collected. Patients receive myeloablative therapy consisting of oral
busulfan every six hours on days -5 to -2. Patients with leukemic progression begin
myeloablative therapy at least 28 days after completion of chemotherapy. Patients receive
autologous peripheral blood stem cells IV on day 0. Patients are followed at 1 month, 3
months, 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 10-44 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of idiopathic myelofibrosis or other myeloproliferative
disorder with myelofibrosis Evidence of advanced disease or hematologic abnormalities due
to severe fibrosis such as 1 or more of the following poor prognostic factors: Hemoglobin
less than 10 g/dL Platelet count less than 100,000/mm3 WBC less than 4,000/mm3 Symptomatic
splenomegaly Constitutional symptoms inadequately controlled with low dose chemotherapy
Abnormal karyotype Patients without evidence of advanced disease undergo PBSC harvest and
transplantation is delayed until there is evidence of disease progression Leukemia
progression (greater than 15% peripheral blood blasts) allowed if the history of a chronic
myeloproliferative disorder of at least 6 months duration is well documented Ineligible
for or refusal of allogeneic transplantation No other cause of myelofibrosis other than
myeloproliferative disorders, such as the following: Metastatic carcinoma Lymphoma Hairy
cell leukemia Myelodysplastic syndrome De novo acute leukemia Collagen vascular disorders
Granulomatous infections

PATIENT CHARACTERISTICS: Age: 75 and under Performance status: Not specified Life
expectancy: Not specified Hematopoietic: See Disease Characteristics WBC no greater than
30,000/mm3 (may be reduced to less than 30,000/mm3 using hydroxyurea or induction
chemotherapy) Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN)*
Transaminases no greater than 2 times ULN* * Unless due to extramedullary hematopoiesis in
the liver Renal: Creatinine no greater than 2 times normal OR Creatinine clearance at
least 50% Cardiovascular: No prior or active congestive heart failure* LVEF at least 50%*
*If receiving study cytoreductive therapy Pulmonary: Total lung capacity at least 50%
predicted OR Corrected DLCO at least 50% predicted Other: No active infection No poorly
controlled seizure disorders Not pregnant or nursing Negative pregnancy test Fertile
patients must use effective barrier contraception HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See
Disease Characteristics At least 7 days since prior hydroxyurea Endocrine therapy: Not
specified Radiotherapy: Not specified Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jeanne E. Anderson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1006.00

NCT ID:

NCT00006367

Start Date:

May 2000

Completion Date:

January 2004

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • polycythemia vera
  • chronic idiopathic myelofibrosis
  • essential thrombocythemia
  • Primary Myelofibrosis
  • Myeloproliferative Disorders

Name

Location
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Mayo Clinic Cancer Center Rochester, Minnesota  55905
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
Washington University Siteman Cancer Center Saint Louis, Missouri  63110
University of Illinois College of Medicine Chicago, Illinois  60612
Katmai Oncology Group Anchorage, Alaska  99508-4627