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Allogeneic Transplantation for Patients With Acute Leukemia or Chronic Myelogenous Leukemia (CML)
Not Recruiting
Trial ID: NCT00185523
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
Stanford Investigator(s)
Judith Shizuru
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)
Laura Johnston
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Negrin
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Lowsky
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
Inclusion 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 remission
2. acute lymphoblastic leukemia, 1st or 2nd remission
3. 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 member
2. Donor or guardian must be competent to give consent
3. Donor must have adequate veins for leukapheresis or agree to placement of central
venous catheter
Exclusion Criteria:3.2 Exclusion Criteria (Patient):
1. Evidence of active infection or active hepatitis
2. Positive serologies for HIV-1,HIV-2 or hepatitis B surface ag+
3. Previous allogeneic stem cell/bone marrow transplant
4. Pregnant or lactating patients
4 Exclusion criteria (Donor):
1. Donors who for psychologic, physiologic or medical reasons are unable to tolerate PBSC
harvest
2. Donors who are HIV+ or hepatitis B antigen +
3. History of allergic reaction to G-CSF
4. Female donors must be post-menopausal or have a negative pregnancy test
Intervention(s):
procedure: Allogeneic hematopoietic cell transplantation
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
BMT Referrals
6507230822