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RecruitingNCT06584006Updated Sep 19, 2024

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

A Phase 2 interventional study of Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections and Recombinant Human Interleukin-2 Injections in Hematological Malignancy and Lymphocytopenia, sponsored by The First Affiliated Hospital of Xiamen University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by The First Affiliated Hospital of Xiamen University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 1 month later.
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Hematological Malignancy
  • Lymphocytopenia
03

In context

Hematologic Neoplasms

1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.

This study's planned enrollment of 50 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

The First Affiliated Hospital of Xiamen University is the lead sponsor of 115 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Combination Therapy Group

    Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections

    Drug: Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections

  • Experimental
    Monotherapy Group

    Recombinant Human Interleukin-2 Injections as a monotherapy

    Drug: Recombinant Human Interleukin-2 Injections

  • No intervention
    Control Group

    non-intervention

Interventions

  • DrugThymalfasin 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.

    Also known as: Combination Therapy Group

  • DrugRecombinant Human Interleukin-2 Injections

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

    Also known as: Monotherapy Group

06

What researchers measure

Primary outcomes

  1. Lymphocyte count and its subgroup count

    Dynamic changes in lymphocyte count and its subgroup count

    Time frame: Up to 36 months

Secondary outcomes

  1. NK cells

    Changes in NK cells

    Time frame: Up to 36 months

  2. Infection

    Incidence of infections

    Time frame: Up to 36 months

  3. Treatment interruption

    Rate of treatment interruption or delay.

    Time frame: Up to 36 months

07

Study locations

1 of 1 sites recruiting
  • Zhijuan Lin
    Xiamen, Fujian, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06584006
Lead sponsor
The First Affiliated Hospital of Xiamen University
Responsible party
Zhijuan Lin (Principal Investigator, The First Affiliated Hospital of Xiamen University) — Principal investigator
First posted
Sep 4, 2024
Start date
Sep 1, 2024
Primary completion
Nov 30, 2027 (estimated)
Completion
Feb 29, 2028 (estimated)
Last update
Sep 19, 2024

Study contacts

Zhijuan Lin
Contact
zjuan_lin@126.com
15960283462
Zhijuan Lin
principal investigator · The First Aiffiliated hosptical of xiamen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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