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

Launched by THE FIRST AFFILIATED HOSPITAL OF XIAMEN UNIVERSITY · Sep 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of two treatments, Thymalfasin and Recombinant Human Interleukin-2, to help patients with low lymphocyte counts (a type of white blood cell) who have certain blood cancers. Low lymphocyte counts can make it harder for the body to fight infections and diseases. The goal of this study is to see if these treatments can safely increase the number of lymphocytes in patients with specific types of blood cancers, such as myeloid tumors and B lymphocyte tumors.

To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of a blood cancer, along with a low lymphocyte count. They should also be expected to live for more than three months. Participants will receive these injections and will be monitored for their health and response to the treatment. It's important to note that certain health conditions, like active autoimmune diseases or recent chemotherapy, may prevent someone from taking part in the trial. Overall, this study aims to find a new way to help improve the immune system in patients dealing with these challenging conditions.

Gender

ALL

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.