Hematological Malignancies Clinical Trial
Official title:
Phase I/II Clinical Trial on Thymosin Alfa 1 of Allogeneic Hematopoietic Transplantation
The purpose of this trial is to determine safety and efficacy of 16 weeks treatment with
thymosin alpha 1 given at 1.6 mg dose once daily by subcutaneous injection in adult patients
with hematological undergone allogenic bone marrow transplantation and CMV positive.
The efficacy will be explored assessing the ability of thymosin alpha1 to prevent the
infection complications.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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