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

September 2, 2024 updated by: Zhijuan Lin, The First Affiliated Hospital of Xiamen University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China
        • Recruiting
        • Zhijuan Lin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination Therapy Group
Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections
Drug: Combination Therapy Group
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.
Other Names:
  • Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections
Experimental: Monotherapy Group
Recombinant Human Interleukin-2 Injections as a monotherapy
Drug: Monotherapy Group
Recombinant Human Interleukin-2 Injections 1 million units subcutaneous injection qd for 7 days.
Other Names:
  • Recombinant Human Interleukin-2 Injections
No Intervention: Control Group
non-intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lymphocyte count and its subgroup count
Time Frame: Up to 36 months
Dynamic changes in lymphocyte count and its subgroup count
Up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NK cells
Time Frame: Up to 36 months
Changes in NK cells
Up to 36 months
Infection
Time Frame: Up to 36 months
Incidence of infections
Up to 36 months
Treatment interruption
Time Frame: Up to 36 months
Rate of treatment interruption or delay.
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xiamen University

Investigators

  • Principal Investigator: Zhijuan Lin, The First Aiffiliated hosptical of xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

February 29, 2028

Study Registration Dates

First Submitted

September 2, 2024

First Submitted That Met QC Criteria

September 2, 2024

First Posted (Actual)

September 4, 2024

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

September 2, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XMDYYYXYK-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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