Phase I/II Clinical Trial on Thymosin Alfa 1 of Allogeneic Hematopoietic Transplantation
This is an open label, monocenter, explorative study . A total of 9 patients will be
included in the study in three sequential cohort of 3 patients each. Patients will enter
into the study after meeting the inclusion and exclusion criteria and signing the Informed
Consent Form.
The first three patients will be treated for 16 weeks starting 40 days after
transplantation; if all three patients will complete the treatment period without any
serious treatment related adverse event then the recruitment of second cohort of patients
will be opened and patients treated starting from 20 days after transplantation. The same
procedure will be applied for the third cohort of patients starting treatment from day of
transplantation.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy in terms of improvement of immunological reconstitution, infectious mortality; safety as prevention of GvHD.
3 years
Yes
Andrea Velardi, Prof
Principal Investigator
Hematology Section, University of Perugia
Italy: Hematology Section, University of Perugia, Italy.
(ST 1472)
NCT00580450
December 2007
December 2010
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