Thymosin Alfa 1 in Recipients of Allogeneic Hematopoietic Transplantation for Hematological Malignancies

Plain-language guide to NCT00580450: phase 1, phase 2 randomized trial of Thymosin Alpha-1, 9 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00580450
Phase: phase 1, phase 2
Status: status unknown
Start: 2007-12
Completion (planned or actual): 2007-12
Participants: 9 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Hematological Malignancies
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 1, phase 2 trial tested Thymosin Alpha-1.

It had two arms (groups): 2 (no intervention) and 1 (experimental).

The registry classes the interventions as drug.

More on the Plan

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 same procedure will be applied for the third cohort of patients starting treatment from day of transplantation.

Who Took Part

The registry lists 9 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Signed written informed consent. Age \> 18 or \< 55. Patients in first complete remission (CR) at high risk of relapse because of unfavourable cytogenetics, such as:. Or other adverse prognostic factors, such as:. CR after second line treatment.

The full record lists 26 inclusion and 9 exclusion criteria; among the exclusions: evidence of active hepatitis (b and/or c) or cirrhosis; HIV positive; presence of any other active, uncontrolled bacterial, viral or fungal infection.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Thymosin Alpha-1 and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Thymosin Alpha-1 study did not mask who received what.

It started in 2007-12 with completion listed for 2007-12.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Thymosin Alpha-1 in 9 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Thymosin Alpha-1 compound page, all human trials.

Our Notes on the Compound

Thymosin Alpha-1: An immune-modulating thymic peptide that recalibrates T-cell function.

Thymosin Alpha-1 in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.