Hematological Malignancy, Lymphocytopenia
Conditions
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 hematological tumors
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 Human Interleukin-2 Injections as a monotherapy, and a non-intervention group. Follow-up observations will also be conducted.
Interventions
DRUGThymalfasin 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.
DRUGRecombinant Human Interleukin-2 Injections
Recombinant Human Interleukin-2 Injections 1 million units subcutaneous injection qd for 7 days.
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lymphocyte count and its subgroup count | Up to 36 months | Dynamic changes in lymphocyte count and its subgroup count |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection | Up to 36 months | Incidence of infections |
| Treatment interruption | Up to 36 months | Rate of treatment interruption or delay. |
| NK cells | Up to 36 months | Changes in NK cells |
Countries
China
Contacts
Primary ContactZhijuan Lin
Outcome results
None listed