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Trial Title:
Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors
NCT ID:
NCT06584006
Condition:
Hematological Malignancy
Lymphocytopenia
Conditions: Official terms:
Hematologic Neoplasms
Lymphopenia
Aldesleukin
Interleukin-2
Thymalfasin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections
Description:
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.
Arm group label:
Combination Therapy Group
Other name:
Combination Therapy Group
Intervention type:
Drug
Intervention name:
Recombinant Human Interleukin-2 Injections
Description:
Recombinant Human Interleukin-2 Injections 1 million units subcutaneous injection qd for
7 days.
Arm group label:
Monotherapy Group
Other name:
Monotherapy Group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhijuan Lin
Address:
City:
Xiamen
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhijuan Lin
Phone:
15960283462
Email:
zjuan_lin@126.com
Start date:
September 1, 2024
Completion date:
February 29, 2028
Lead sponsor:
Agency:
The First Affiliated Hospital of Xiamen University
Agency class:
Other
Source:
The First Affiliated Hospital of Xiamen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06584006
