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Trial · Interventional

RecruitingPhase 2Registry data

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

Overview

Status
Recruiting
Phase
Phase 2
Enrollment
50 participants (estimated)
Sponsor
The First Affiliated Hospital of Xiamen University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
1 Sept 2024
Primary completion
30 Nov 2027 (estimated)
Completion
29 Feb 2028 (estimated)
First posted
4 Sept 2024
Last update posted
19 Sept 2024
Conditions
Hematological Malignancy · Lymphocytopenia

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026202720282029
  1. Ph 2

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

    NCT06584006

    1 Sept 2024 to est. 29 Feb 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Thymalfasin for injection in combination with Recombinant Human Interleukin-2 InjectionsDrug
  • Recombinant Human Interleukin-2 InjectionsDrug

Arms3

  • Experimental

    Combination Therapy Group

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

  • Experimental

    Monotherapy Group

    Recombinant Human Interleukin-2 Injections as a monotherapy

  • No intervention

    Control Group

    non-intervention

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Lymphocyte count and its subgroup count

    Time frame · Up to 36 months

    Registry description

    Dynamic changes in lymphocyte count and its subgroup count

Secondary outcomes(3)
  1. NK cells

    Time frame · Up to 36 months

    Registry description

    Changes in NK cells

  2. Infection

    Time frame · Up to 36 months

    Registry description

    Incidence of infections

  3. Treatment interruption

    Time frame · Up to 36 months

    Registry description

    Rate of treatment interruption or delay.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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