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thymosin-alpha-1 immune modulator rct 2024-09-01 ClinicalTrials

New Clinical Trial Tests Combination Therapy for Low Lymphocytes in Cancer Patients

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

Background

Patients with malignant hematological tumors (blood cancers) frequently experience lymphocytopenia, a condition characterized by abnormally low levels of lymphocytes, a critical type of white blood cell. This immune deficiency often results from the disease itself or its intensive treatments, significantly increasing the risk of infections and potentially worsening prognosis. Despite current supportive care, the optimal strategy to effectively restore lymphocyte counts and improve immune function in these vulnerable patients remains unclear.

Results

As this is a recruiting Phase II clinical trial (NCT ID: NCT06584006), specific efficacy and safety data are not yet available. However, the trial is designed to rigorously assess the impact of the interventions on lymphocyte counts and overall immune recovery. Researchers will monitor changes in various immune cell populations and evaluate the incidence of adverse events to determine the safety profile of both the monotherapy and combination approaches. The primary objective is to identify whether the active treatment arms can significantly improve immune status. The primary goal is to determine if the combination of Thymalfasin and IL-2 can significantly improve lymphocyte counts compared to IL-2 alone or no intervention in patients with malignant hematological tumors.

Why It Matters

This trial addresses a critical unmet need for improving immune function in cancer patients, as lymphocytopenia severely compromises the body's ability to fight infections and potentially control cancer progression. If the combination of Thymalfasin and IL-2 proves effective and safe, it could provide a novel and much-needed treatment strategy to enhance immune recovery and improve clinical outcomes for patients with malignant hematological tumors. Positive results from this Phase II study would be a crucial step, paving the way for larger Phase III human trials to confirm these findings and potentially lead to new clinical guidelines for managing immune deficiencies in oncology.


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Source: clinicaltrials:NCT06584006 · Ingested 2026-04-07 · Digest: gemini-2.5-flash