Status:
TERMINATED
Stem Cell Transplantation for Hematological Malignancies
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Leukemia, Lymphocytic, Acute
AML
Eligibility:
All Genders
Up to 35 years
Phase:
PHASE2
PHASE3
Brief Summary
This protocol using busulfan, cyclophosphamide and melphalan has been designed as conditioning therapy for patients receiving stem cell transplantation for acute leukemia or myelodysplastic syndrome (...
Detailed Description
Subjects will be admitted to the bone marrow transplant unit and put in isolation to reduce exposure to infectious agents. Prior to transplantation, they will receive BUSULFAN via the central venous ...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and currently be in complete remission.
- Patients must be either:
- \- \<18 years of age who are at least 6 months after initial hematopoietic cell transplant (HCT),
- \- 19-35 years of age and at least 18 months after initial HCT, or
- \- \<35 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (TBI) containing preparative therapy
- Adequate major organ function including:
- \- Cardiac: ejection fraction \> or = 45%
- \- Renal: creatinine clearance \> or = 40 mL/min
- \- Hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites)
- \- Karnofsky performance status \> or = 70% or Lansky score \> or = 50%
- Women of child bearing age must be using adequate birth control and have a negative pregnancy test.
- Written informed consent.
Exclusion
- Eligible for TBI containing preparative regimen.
- Active uncontrolled infection within one week of HCT.
- Pregnant or lactating females.
Key Trial Info
Start Date :
June 7 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00176839
Start Date
June 7 2000
End Date
February 1 2012
Last Update
December 5 2017
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455