Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation
Recruiting in Palo Alto (17 mi)
Overseen byScott Solomon, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northside Hospital, Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial will evaluate the safety and efficacy of RIC HIDT transplant protocol following fludarabine and intermediate-dose TBI 800 cGy utilizing PBSC as the stem cell source.
Eligibility Criteria
Inclusion Criteria
Availability of 3/6 - 5/6 matched related donor with a negative HLA-cross match in the host vs. graft direction willing to donate peripheral blood stem cells
KPS >/= 70%
Hematologic malignancy requiring allogeneic transplantation, with a predicted high risk of relapse following non-myeloablative, low intensity conditioning.
Treatment Details
Interventions
- Fludarabine (Anti-metabolites)
- Haplo-Identical Transplantation (Procedure)
- Total Body Irradiation (TBI) (Radiation Therapy)
Fludarabine is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Fludara for:
- Chronic lymphocytic leukemia
- Mantle-cell lymphoma
- Non-Hodgkin's lymphoma
🇺🇸 Approved in United States as Fludara for:
- Chronic lymphocytic leukemia
- Non-Hodgkin's lymphoma
- Stem Cell Transplant Conditioning
🇨🇦 Approved in Canada as Fludara for:
- Chronic lymphocytic leukemia
- Non-Hodgkin's lymphoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Caitlin GuzowskiAtlanta, GA
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Who Is Running the Clinical Trial?
Northside Hospital, Inc.Lead Sponsor