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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Lymphocyte count and its subgroup count
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Able to understand and voluntarily provide informed consent.
排除标准
- •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-
- •Any other condition that the researcher believes makes the patient unsuitable for this trial.
研究组 & 干预措施
Combination Therapy Group
Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections
干预措施: Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections (Drug)
Monotherapy Group
Recombinant Human Interleukin-2 Injections as a monotherapy
干预措施: Recombinant Human Interleukin-2 Injections (Drug)
结局指标
主要结局
Lymphocyte count and its subgroup count
时间窗: Up to 36 months
Dynamic changes in lymphocyte count and its subgroup count
次要结局
- NK cells(Up to 36 months)
- Infection(Up to 36 months)
- Treatment interruption(Up to 36 months)
研究者
Zhijuan Lin
The First Affiliated Hospital of Xiamen University
The First Affiliated Hospital of Xiamen University