Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy.
Sometimes the transplanted cells reject the body’s normal tissues. Alemtuzumab may prevent this from happening.
Official Title
Phase II Study of Submyeloablative Conditioning Regimen Comprising Low-Dose Total Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplantation in Patients With Myeloproliferative Disorders or Myelodysplastic Syndromes
Conditions
– Polycythemia Vera- Essential Thrombocythemia- de novo myelodysplastic syndromes- previously treated myelodysplastic syndromes- secondary myelodysplastic syndromes- chronic idiopathic myelofibrosisPhase II
Study Type
Interventional
Study Design
Treatment
Further Details
Study Start
Eligibility & Criteria
Eligibility Ages Eligible for Study: up to 69 Years, Genders Eligible for Study: Both Criteria DISEASE CHARACTERISTICS:Diagnosis of 1 of the following: Myelodysplastic syndromes with International Prognostic Scoring System score greater than 0 One of the following myeloproliferative disorders: Primary myelofibrosis with Lile score of 1 or 2 Polycythemia vera (PV) or essential thrombocythemia transformed to acute myeloid leukemia or myelofibrosis and PV “spent phase” No chronic myelogenous leukemia Available 5/6 or 6/6 related or unrelated (molecular typing for DRB1) healthy donor No active CNS disease from hematologic disorder PATIENT CHARACTERISTICS: AgeUnder 70 Performance statusZubrod 0-2 Life expectancyNot specified HematopoieticNot specified HepaticNo active hepatitis No cirrhosis Bilirubin no greater than 3 times normal SGOT and SGPT no greater than 3 times normal RenalNo dependence on hemodialysis CardiovascularNo unstable angina No uncompensated congestive heart failure No unstable cerebral vascular disease No hemorrhagic stroke within the past 6 months PulmonaryNo severe chronic pulmonary disease requiring oxygen OtherNot pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation HIV negative No concurrent uncontrolled infection No concurrent solid organ malignancy not in remission, except stage 0 or A prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapyNot specified ChemotherapyNot specified Endocrine therapyNot specified RadiotherapyNot specified SurgeryNot specified
Total Enrolment
Contact Details
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