Status:
TERMINATED
Stem Cell Transplant for Hematological Malignancy
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Leukemia, Myeloid, Chronic
AML
Eligibility:
All Genders
Up to 55 years
Phase:
NA
Brief Summary
The purpose of this study is to develop a standard of care treatment using allogeneic stem cells for patients with cancers of the blood. The protocol was revised to reflect that this study is conside...
Detailed Description
Preparative regimen using total body irradiation (TBI) and cyclophosphamide: 1. on day -6 and -5: cyclophosphamide is given, 2. on day -4, -3, -2, and -1: TBI is given, 3. on day 0: stem cell or bone...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Donor will be \<75 years of age and in good health.
- Recipients will be \< or = 55 years, will have normal organ function (excluding bone marrow) and will have a Karnofsky activity assessment \> or = 90%.
- Recipients with related or unrelated donor matched at the HLA A, B, DRB1 loci, or mismatched related or unrelated (if \< 35 years old) at a single HLA A, B, DRB1 locus.
- Recipients will be eligible in one of the following disease categories
- Chronic myelogenous leukemia in accelerated phase or in post blast crisis second or greater chronic phase; or in chronic phase but intolerant of or resistant to tyrosine kinase inhibitors.
- Acute myelocytic leukemia in first or greater remission, or first, second or third relapse.
- Acute lymphocytic leukemia in the 2nd or greater bone marrow remission.
- High risk children will be transplanted in first remission if they meet criteria
- Myelodysplastic syndrome.
- Myeloproliferative Diseases - (i.e. myelofibrosis, chronic myelomonocytic leukemia (CMML))
- Juvenile myelomonocytic leukemia
- Chronic lymphocytic leukemia
- Advanced non-Hodgkin's (NHL).
- Advanced Hodgkin's disease beyond PR2 (\> CR3, \> PR3).
- Multiple Myeloma after initial therapy.
- Donors and recipients signed informed consent
- Exclusion Criteria
- donors and recipients should meet the following test criteria.
- required for donors:
- anti-HIV, Hepatitis B, surface antigen, anti-HCV, CMV, HSV, EBV serologies, pre-priming.
- CBC, platelet count each day of apheresis, day 0 (or 1 or 2 as needed)
- required for recipients:
- anti-HIV, Hepatitis B, surface antigen, anti-HCV, CMV, HSV, EBV serologies, pre-transplant.
Exclusion
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00176930
Start Date
October 1 2001
End Date
December 1 2019
Last Update
January 22 2021
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455