Current partner codePEPTIDESDE
NCT06584006·Phase 2·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 2

Enrollment

50

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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

Treatment arms and agents.

DRUG

Thymalfasin 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.

DRUG

Recombinant Human Interleukin-2 Injections

Recombinant Human Interleukin-2 Injections 1 million units subcutaneous injection qd for 7 days.

Timeline

From registration to results.

  1. First posted

    Sep 4, 2024

  2. Study start

    Sep 1, 2024

  3. Primary completion

    Nov 30, 2027

  4. Study completion

    Feb 29, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Sep 19, 2024

Outcomes

What the study measures.

Primary outcomes

Lymphocyte count and its subgroup count

Time frame · Up to 36 months

Dynamic changes in lymphocyte count and its subgroup count

Secondary outcomes

NK cells

Time frame · Up to 36 months

Changes in NK cells

Infection

Time frame · Up to 36 months

Incidence of infections

Treatment interruption

Time frame · Up to 36 months

Rate of treatment interruption or delay.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Zhijuan Lin

Xiamen, Fujian, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

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