Status:
RECRUITING
Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Conditions:
Hematological Malignancy
Lymphocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 hematolog...
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 Huma...
Eligibility Criteria
Inclusion
- Patients with histologically confirmed myeloid, B lymphocyte, and plasma cell-derived malignant hematological tumors.
- Lymphocyte count ≤ 0.8×109/L or CD4+T cell count ≤ 0.35×109/L.
- Age ≥ 18 years, both male and female, with an expected survival period of more than 3 months.
- Estimated creatinine clearance rate ≥ 30 mL/min.
- AST and ALT ≤ 3.0 x ULN. Bilirubin ≤ 1.5 x ULN.
- ECOG ≤ 2.
- Able to understand and voluntarily provide informed consent.
Exclusion
- Active autoimmune disease.
- Patients considered to have a malignant T-cell clone.
- Within 8 days after chemotherapy for lymphoma and within 14 days after chemotherapy for AML.
- Tumor involvement in the bone marrow leading to hematopoietic suppression (neutrophils \<1.0×10\^9/L, HB\<70g/L, PLT\<50×10\^9/L).
- HIV-positive patients and/or active HBV or HCV infection (as evidenced by positive HBV-DNA and HCV-RNA test records).
- Patients with chronic respiratory diseases requiring continuous oxygen, or with significant past medical history of kidney, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular diseases.
- Immunosuppressive treatment (such as cyclosporine, corticosteroids, ruxolitinib, JAK1/2 inhibitors, etc.) within the past 5 days.
- Psychiatric disorders that would interfere with study participation.
- Patients who have undergone allogeneic hematopoietic stem cell transplantation.
- Consideration of allergy to Thymalfasin or Interleukin-2.
- Any other condition that the researcher believes makes the patient unsuitable for this trial.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 29 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06584006
Start Date
September 1 2024
End Date
February 29 2028
Last Update
September 19 2024
Active Locations (1)
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1
Zhijuan Lin
Xiamen, Fujian, China