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

Phase 2

Recruiting

• Conditions: Hematological Malignancy; Lymphocytopenia
• Interventions: Drug: Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections; Drug: Recombinant Human Interleukin-2 Injections

• Registration Number: NCT06584006
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

Brief Summary

To evaluate the efficacy and safety of Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections in the treatment of lymphocytopenia in patients with malignant hematological tumors

Detailed Description

A prospective, randomized controlled study is proposed to evaluate the efficacy and safety of Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections, Recombinant Human Interleukin-2 Injections as a monotherapy, and a non-intervention group. Follow-up observations will also be conducted.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-01
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-02
• Last Update Submitted: 2024-09-02
• Study First Posted: 2024-09-04
• Last Update Posted: 2024-09-04
• Primary Completion: 2027-11-30
• Study Completion: 2028-02-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination Therapy Group	Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections	Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections
Monotherapy Group	Recombinant Human Interleukin-2 Injections	Recombinant Human Interleukin-2 Injections as a monotherapy

Primary Outcome Measures

Name	Time	Method
Lymphocyte count and its subgroup count	Up to 36 months	Dynamic changes in lymphocyte count and its subgroup count

Secondary Outcome Measures

Name	Time	Method
NK cells	Up to 36 months	Changes in NK cells
Infection	Up to 36 months	Incidence of infections
Treatment interruption	Up to 36 months	Rate of treatment interruption or delay.

Trial Locations

Locations (1)

Zhijuan Lin; 🇨🇳 Xiamen, Fujian, China