Status:
COMPLETED
Defibrotide TMA Prophylaxis Pilot Trial
Lead Sponsor:
University of California, San Francisco
Conditions:
Thrombotic Microangiopathies
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE2
Brief Summary
Thrombotic microangiopathy (TMA) is a common complication in the stem cell transplant population. Certain populations within the hematopoietic stem cell transplant (HSCT) population are at a higher ri...
Detailed Description
This is an open-label, single arm pilot study of defibrotide given as prophylaxis to patients receiving a conditioned stem cell transplant for the purpose of preventing post-transplant microangiopathy...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age 0-30 years of age
- Life expectancy \> 6 months
- Eastern Cooperative Oncology Group or Karnofsky Performance Status \>40
- Meets minimum organ function requirements per institutional standard of care guiding clearance for autologous or allogeneic stem cell transplantation.
- Patients must meet TMA High-Risk criteria 5A or 5B below:
- 5A. Patients undergoing tandem autologous transplant with thiotepa in one or more of the conditioning regimens
- OR:
- 5B. . Patients with at least 3 of the following characteristics:
- \>10 years of age
- Non-Caucasian race/ Hispanic ethnicity
- Undergoing haploidentical transplant
- Minor ABO blood group mismatch
- Exclusion Criteria:
- Age \>30 years
- Life expectancy \< 6 months
- Known bleeding diathesis or bleeding risk deemed by the treating physician to be a contraindication to administration of anticoagulants.
- Known hypersensitivity reaction to defibrotide
- Any patient not meeting TMA High-Risk criteria
- Pregnant women are excluded from this study because they will be receiving teratogenic therapy as part of the stem cell transplant.
Exclusion
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03384693
Start Date
May 1 2018
End Date
July 31 2020
Last Update
September 16 2021
Active Locations (1)
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1
Benioff Children's Hospital at UCSF Medical Center
San Francisco, California, United States, 94143