Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors
Recruiting now · Phase 2
Conditions studied: Hematological Malignancy, Lymphocytopenia
In brief
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
Key facts
- Study ID
- NCT06584006
- Run by
- The First Affiliated Hospital of Xiamen University
- People needed
- 50
- Starts
- 2024-09-01
- Expected to finish
- 2028-02-29
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Zhijuan Lin — Xiamen, Fujian, China (enrolling)
Full record on ClinicalTrials.gov
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