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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections
  Thymalfasin for injection 1.6mg subcutaneous injection once daily (qd) for 7 days, and Recombinant Human Interleukin-2 Injections 1 million units subcutaneous injection qd for 7 days.
• Препарат Recombinant Human Interleukin-2 Injections
  Recombinant Human Interleukin-2 Injections 1 million units subcutaneous injection qd for 7 days.

Первичные конечные точки

• Lymphocyte count and its subgroup count [Срок оценки: Up to 36 months]

Вторичные конечные точки (3)

• NK cells [Срок оценки: Up to 36 months]
• Infection [Срок оценки: Up to 36 months]
• Treatment interruption [Срок оценки: Up to 36 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhijuan Lin — Xiamen

Идентификаторы

NCT: NCT06584006 · XMDYYYXYK-12

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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