Status:
TERMINATED
Allogeneic Transplantation for Patients With Acute Leukemia or Chronic Myelogenous Leukemia (CML)
Lead Sponsor:
Stanford University
Conditions:
Leukemia, Lymphocytic, Acute
Leukemia
Eligibility:
All Genders
4-55 years
Brief Summary
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.
Detailed Description
Allogeneic Peripheral Blood Stem Cell Transplantation for Patients with Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia in First Remission or Chronic Myelogenous Leukemia in First Chronic ...
Eligibility Criteria
Inclusion
- Any patient with one of the following hematologic malignancies in whom an allogeneic stem cell transplant is warranted: Specific disease categories include:
- acute myelogenous leukemia, 1st or 2nd remission
- acute lymphoblastic leukemia, 1st or 2nd remission
- 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):
- HLA identical family member
- Donor or guardian must be competent to give consent
- Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter
Exclusion
- 2 Exclusion Criteria (Patient):
- Evidence of active infection or active hepatitis
- Positive serologies for HIV-1,HIV-2 or hepatitis B surface ag+
- Previous allogeneic stem cell/bone marrow transplant
- Pregnant or lactating patients
- 4 Exclusion criteria (Donor):
- Donors who for psychologic, physiologic or medical reasons are unable to tolerate PBSC harvest
- Donors who are HIV+ or hepatitis B antigen +
- History of allergic reaction to G-CSF
- Female donors must be post-menopausal or have a negative pregnancy test
Key Trial Info
Start Date :
May 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00185523
Start Date
May 1 2002
End Date
April 1 2009
Last Update
June 16 2016
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305