Using Thymalfasin and IL-2 to treat low lymphocyte levels in blood cancer patients

A Phase II, Single-Center, Randomized Controlled Clinical Trial Evaluating the Efficacy of Thymalfasin and Recombinant Human Interleukin-2 Injections in Treating Lymphocytopenia in Patients With Malignant Hematological Tumors

This study is testing if a combination of two injections can help blood cancer patients with low lymphocyte levels feel better and improve their health.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Xiamen University (Academic / other)
• Drugs / interventions: ruxolitinib, chemotherapy
• Locations: 1 site (Xiamen, Fujian)
• Trial ID: NCT06584006 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of Thymalfasin injections combined with Recombinant Human Interleukin-2 injections for treating lymphocytopenia in patients with malignant hematological tumors. It is a prospective, randomized controlled study that includes a comparison between the combination therapy, IL-2 monotherapy, and a non-intervention group. Participants will be monitored for their response to treatment and any adverse effects throughout the study period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed malignant hematological tumors and low lymphocyte counts.

Not a fit: Patients with active autoimmune diseases, certain types of T-cell malignancies, or those currently undergoing chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve lymphocyte levels and overall immune function in patients with blood cancers, potentially enhancing their treatment outcomes.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in enhancing immune responses in patients with hematological malignancies.

Eligibility criteria

Inclusion Criteria:

1. Patients with histologically confirmed myeloid, B lymphocyte, and plasma cell-derived malignant hematological tumors.
2. Lymphocyte count ≤ 0.8×109/L or CD4+T cell count ≤ 0.35×109/L.
3. Age ≥ 18 years, both male and female, with an expected survival period of more than 3 months.
4. Estimated creatinine clearance rate ≥ 30 mL/min.
5. AST and ALT ≤ 3.0 x ULN. Bilirubin ≤ 1.5 x ULN.
6. ECOG ≤ 2.
7. Able to understand and voluntarily provide informed consent.

Exclusion Criteria:

1. Active autoimmune disease.
2. Patients considered to have a malignant T-cell clone.
3. Within 8 days after chemotherapy for lymphoma and within 14 days after chemotherapy for AML.
4. Tumor involvement in the bone marrow leading to hematopoietic suppression (neutrophils \<1.0×10\^9/L, HB\<70g/L, PLT\<50×10\^9/L).
5. HIV-positive patients and/or active HBV or HCV infection (as evidenced by positive HBV-DNA and HCV-RNA test records).
6. Patients with chronic respiratory diseases requiring continuous oxygen, or with significant past medical history of kidney, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular diseases.
7. Immunosuppressive treatment (such as cyclosporine, corticosteroids, ruxolitinib, JAK1/2 inhibitors, etc.) within the past 5 days.
8. Psychiatric disorders that would interfere with study participation.
9. Patients who have undergone allogeneic hematopoietic stem cell transplantation.
10. Consideration of allergy to Thymalfasin or Interleukin-2.
11. Any other condition that the researcher believes makes the patient unsuitable for this trial.

Where this trial is running

Xiamen, Fujian

• Zhijuan Lin — Xiamen, Fujian, China (Recruiting)

Study contacts

• Principal investigator: Zhijuan Lin — The First Aiffiliated hosptical of xiamen University
• Study coordinator: Zhijuan Lin

Conditions Hematological Malignancy; Lymphocytopenia