Clinical trial NCT06584006: Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hematological Malignancy
Lymphocytopenia
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Lymphocyte count and its subgroup count
timeFrame: Up to 36 months
Secondary outcomes:
measure: NK cells
timeFrame: Up to 36 months
measure: Infection
timeFrame: Up to 36 months
measure: Treatment interruption
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Zhijuan Lin
state: Fujian
Study officials:
affiliation: The First Aiffiliated hosptical of xiamen University
name: Zhijuan Lin
role: PRINCIPAL_INVESTIGATOR
References: