Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors

What Was Tested

In this phase 2 trial, researchers set out to test Thymosin Alpha-1.

It had three arms (groups): Combination Therapy Group (experimental), Monotherapy Group (experimental) and Control Group (no intervention).

Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections.

Recombinant Human Interleukin-2 Injections as a monotherapy.

Non-intervention.

The registry classes the interventions as drug.

More on the Plan

Follow-up observations will also be conducted.

Who Took Part

Enrollment: 50 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Patients with histologically confirmed myeloid, B lymphocyte, and plasma cell-derived malignant hematological tumors. Lymphocyte count ≤ 0.8×109/L or CD4+T cell count ≤ 0.35×109/L. Age ≥ 18 years, both male and female, with an expected survival period of more than 3 months. AST and ALT ≤ 3.0 x ULN. Bilirubin ≤ 1.5 x ULN. ECOG ≤ 2.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: active autoimmune disease; patients considered to have a malignant t-cell clone; within 8 days after chemotherapy for lymphoma and within 14 days after chemotherapy for aml.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Thymosin Alpha-1 group and the comparison group should start out alike.

The Thymosin Alpha-1 group and the comparison group ran side by side rather than switching.

Everyone knew when Thymosin Alpha-1 was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-09-01 with completion listed for 2027-11-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Lymphocyte count and its subgroup count (time frame: Up to 36 months).

It also tracked 3 secondary outcomes, for example NK cells, Infection and Treatment interruption.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Thymosin Alpha-1 in 50 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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