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Recruiting NCT06584006

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

Phase II Interventional Hematological Malignancy Lymphocytopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections, Recombinant Human Interleukin-2 Injections.
Who it may be relevant to
Registry conditions: Hematological Malignancy, Lymphocytopenia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Lymphocyte count and its subgroup count [Time frame: Up to 36 months]
Secondary outcome measures (3)
  • NK cells [Time frame: Up to 36 months]
  • Infection [Time frame: Up to 36 months]
  • Treatment interruption [Time frame: Up to 36 months]

Eligibility criteria

Inclusion criteria

  • Patients with histologically confirmed myeloid, B lymphocyte, and plasma cell-derived malignant hematological tumors.
  • Lymphocyte count ≤ 0.8×109/L or CD4+T cell count ≤ 0.35×109/L.
  • Age ≥ 18 years, both male and female, with an expected survival period of more than 3 months.
  • Estimated creatinine clearance rate ≥ 30 mL/min.
  • AST and ALT ≤ 3.0 x ULN. Bilirubin ≤ 1.5 x ULN.
  • ECOG ≤ 2.
  • Able to understand and voluntarily provide informed consent.

Exclusion criteria

  • Active autoimmune disease.
  • Patients considered to have a malignant T-cell clone.
  • Within 8 days after chemotherapy for lymphoma and within 14 days after chemotherapy for AML.
  • Tumor involvement in the bone marrow leading to hematopoietic suppression (neutrophils <1.0×10\^9/L, HB<70g/L, PLT<50×10\^9/L).
  • HIV-positive patients and/or active HBV or HCV infection (as evidenced by positive HBV-DNA and HCV-RNA test records).
  • Patients with chronic respiratory diseases requiring continuous oxygen, or with significant past medical history of kidney, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular diseases.
  • Immunosuppressive treatment (such as cyclosporine, corticosteroids, ruxolitinib, JAK1/2 inhibitors, etc.) within the past 5 days.
  • Psychiatric disorders that would interfere with study participation.
  • Patients who have undergone allogeneic hematopoietic stem cell transplantation.
  • Consideration of allergy to Thymalfasin or Interleukin-2.
  • Any other condition that the researcher believes makes the patient unsuitable for this trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhijuan Lin — Xiamen

Identifiers

NCT: NCT06584006 · XMDYYYXYK-12

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗