| Official Title: |
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Study of Fludarabine Based Conditioning for Allogeneic Stem Cell Transplantation for Myelofibrosis |
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| Investigator: |
Saul Yanovich, M.D. |
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| Summary: |
Allogeneic transplant provides the only curative approach for MMM patients; however, in studies where standard myeloablative preparative radio/chemotherapy regimes were used a high transplant related mortality (TRM) was observed. TRM and recurrence of disease account for the majority of treatment failures in allogeneic transplantation for advanced chematologic malignancies. For patients with advanced myelofibrosis disease a reduced intensity conditioning regimen offers these patients a potential for cure with limited toxicities. The primary objective is to estimate progression free survival and overall survival of patients with myelofibrosis undergoing an allogeneic HSC transplant prepared with a reduced intensity conditioning regimen. |
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| Disease site: |
Hematologic Malignancies,Stem Cell Transplant |
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| Disease stage: |
Advanced myelofibrosis |
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| Condition: |
MYELOFIBROSIS |
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| Intervention: |
Reduced Intensity Conditioning Chemotherapy |
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| Phase: |
II |
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| Study number: |
GCC 0911 |
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Eligibility*
(inclusion criteria) |
Patients with the following disease: Idiopathic myelofibrosis, or spent PV-, or ET-related myelofibrosis in chronic phase as defined by the protocol; Age 18-65 years;Adequate cardiac function as defined by the protocol;No evidence of chronic active hepatitis or cirrhosis; HIV-negative;Patient is not pregnant; Patients should be off treatment with investigational for at least 4 weeks and have
recovered from all toxicities.
(exclusion criteria)
HIV positive;Pregnancy; Chronic active hepatitis or cirrhosis;Chronic renal insufficiency; > 20% myeloblasts in the peripheral blood or bone marrow.
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Contact Person
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Sunita Philip, MS 410-328-8199 |
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| * Note: This study may include eligibility criteria that are not listed here. For more information about the study or to find out if you are eligible, call 1-800-888-8823. |