Thymosin Alfa 1 in Recipients of Allogeneic Hematopoietic Transplantation for Hematological Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00580450|
Recruitment Status : Unknown
Verified November 2007 by University Of Perugia.
Recruitment status was: Not yet recruiting
First Posted : December 24, 2007
Last Update Posted : December 24, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Hematological Malignancies||Drug: Thymosin alpha 1||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Clinical Trial on Thymosin Alfa 1 of Allogeneic Hematopoietic Transplantation|
|Study Start Date :||December 2007|
|Primary Completion Date :||December 2007|
|Estimated Study Completion Date :||December 2010|
|No Intervention: 2|
Drug: Thymosin alpha 1
1.6 mg sc once a day for 16 weeks
- Efficacy in terms of improvement of immunological reconstitution, infectious mortality; safety as prevention of GvHD. [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580450
|Contact: Andrae Velardi, MD, Prof.||+39 075 578 email@example.com|
|Hematology Section, University of Perugia||Not yet recruiting|
|Perugia, Italy, 06122|
|Contact: Massimo F Martelli, Prof +39 075 578 4170 firstname.lastname@example.org|
|Contact: Franco Aversa, Prof +39 075 578 4179 email@example.com|
|Sub-Investigator: Katia Perruccio, MD, PhD|
|Sub-Investigator: Luigina Romani, Prof|
|Principal Investigator:||Andrea Velardi, Prof||Hematology Section, University of Perugia|