Allogeneic Transplantation for Patients With Acute Leukemia or Chronic Myelogenous Leukemia (CML)
NCT ID: NCT00185523
Last Updated: 2016-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
88 participants
OBSERVATIONAL
2002-05-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CML in first Chronic Phase or Accelerated Phase
Busulfan/cyclophosphamide Day -7: Busulfan 1.0 mg/kg IV q6 hrs\*\* Day -6: Busulfan 1.0 mg/kg IV q6 hrs Day -5: Busulfan 1.0 mg/kg IV q6 hrs Day -4: Busulfan 1.0 mg/kg IV q6 hrs Day -3: Cyclophosphamide 60 mg/kg Day -2: Cyclophosphamide 60 mg/kg Day -1: rest Day 0: Allogeneic PBSC infusion
Allogeneic hematopoietic cell transplantation
AML and ALL in first or second remission
FTBI/VP-16 Day -7: FTBI 120 cGy x 3 fractions Day -6: FTBI 120 cGy x 2 fractions Day -5: FTBI 120 cGy x 3 fractions Day -4: FTBI 120 cGy x 3 fractions\* Day -3: VP-16 at 60 mg/kg Day -2: rest Day -1: rest Day 0: Allogeneic PBSC infusion
Allogeneic hematopoietic cell transplantation
Interventions
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Allogeneic hematopoietic cell transplantation
Eligibility Criteria
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Inclusion Criteria
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.
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
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
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
4 Weeks
55 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Principal Investigators
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Ginna Laport
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University School of Medicine
Stanford, California, United States
Countries
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Other Identifiers
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78149
Identifier Type: -
Identifier Source: secondary_id
NCT00185523
Identifier Type: -
Identifier Source: secondary_id
12570
Identifier Type: OTHER
Identifier Source: secondary_id
BMT142
Identifier Type: -
Identifier Source: org_study_id
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