Allogeneic Transplantation for Patients With Acute Leukemia or Chronic Myelogenous Leukemia (CML)
Trial ID or NCT#
Status
Purpose
The purpose of the study is to evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stem cells from HLA matched sibling donors.
Official Title
Allogeneic Peripheral Blood Stem Cell Transplantation for Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia in First or Second Remission or Chronic Myelogenous Leukemia in First and Second Chronic Phase or Accelerated Phase
Eligibility Criteria
- 1. Any patient with one of the following hematologic malignancies in whom an allogeneic stem cell transplant is warranted: Specific disease categories include:
- 1. acute myelogenous leukemia, 1st or 2nd remission2. acute lymphoblastic leukemia, 1st or 2nd remission3. chronic myelogenous leukemia, 1st or 2nd CP, accelerated phase 2. Patient age \> 1 month and \< 55 yo 3. Patients must have a genotypically HLA identical sibling 4. Patient must have adequate function as follows:
- a. total bilirubin \<2.5 and SGOT/SGPT \<2x normal b. adequate renal function as defined by creatinine \< 1.5 or a 24 hr creatinine clearance \>50 cc/min as determined by the Cockroft-Gault formula (to be done if serum creatinine \> 1.5) c. DLCO \> 60% predicted d. radionuclide cardiac scan with ejection fraction \>45% 5. Patient must be competent to give consent.
- Inclusion criteria (Donor):
- 1. HLA identical family member2. Donor or guardian must be competent to give consent3. Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter
- 3.2 Exclusion Criteria (Patient):
- 1. Evidence of active infection or active hepatitis2. Positive serologies for HIV-1,HIV-2 or hepatitis B surface ag+3. Previous allogeneic stem cell/bone marrow transplant4. Pregnant or lactating patients
- 4 Exclusion criteria (Donor):
- 1. Donors who for psychologic, physiologic or medical reasons are unable to tolerate PBSC harvest2. Donors who are HIV+ or hepatitis B antigen +3. History of allergic reaction to G-CSF4. Female donors must be post-menopausal or have a negative pregnancy test
Investigator(s)
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Contact
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6507230822
View on ClinicalTrials.gov