NCT06584006 Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors
| NCT ID | NCT06584006 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Xiamen University |
| Condition | Hematological Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2024-09-01 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Zhijuan Lin
PRINCIPAL INVESTIGATOR
The First Aiffiliated hosptical of xiamen University
Frequently Asked Questions
Who can join the NCT06584006 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematological Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06584006 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06584006 currently recruiting?
Yes, NCT06584006 is actively recruiting participants. Contact the research team at zjuan_lin@126.com for enrollment information.
Where is the NCT06584006 trial being conducted?
This trial is being conducted at Xiamen, China.
Who is sponsoring the NCT06584006 clinical trial?
NCT06584006 is sponsored by The First Affiliated Hospital of Xiamen University. The principal investigator is Zhijuan Lin at The First Aiffiliated hosptical of xiamen University. The trial plans to enroll 50 participants.