Clinical trial · Interventional
Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors
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
NCT06584006CI-TRIAL-00080875recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Lymphocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant Human Interleukin-2 Injections | Drug | — | UNRESOLVED |
| Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Combination Therapy Group
- description
- Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections
- interventionNames
- Drug: Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections
- type
- EXPERIMENTAL
- label
- Monotherapy Group
- description
- Recombinant Human Interleukin-2 Injections as a monotherapy
- interventionNames
- Drug: Recombinant Human Interleukin-2 Injections
- type
- NO_INTERVENTION
- label
- Control Group
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.