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

Xiamen University

Status and phase: Enrolling; Phase 2

Conditions: Hematological Malignancy; Lymphocytopenia

Treatments: Drug: Recombinant Human Interleukin-2 Injections; Drug: Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections

Study type: Interventional

Funder types: Other

Identifiers

NCT06584006

XMDYYYXYK-12

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Combination Therapy Group

Experimental group

Description:

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

Treatment:

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

Monotherapy Group

Experimental group

Description:

Recombinant Human Interleukin-2 Injections as a monotherapy

Treatment:

Drug: Recombinant Human Interleukin-2 Injections

Control Group

No Intervention group

Description:

non-intervention