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

NCT06584006 | Recruiting Phase 2

• 1 other identifier: XMDYYYXYK-12
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hematological Malignancy; Lymphocytopenia

Outcome Measures

Primary Outcomes (1)

• Lymphocyte count and its subgroup count

  Dynamic changes in lymphocyte count and its subgroup count

  Up to 36 months

Secondary Outcomes (3)

• NK cells

  Up to 36 months

• Infection

  Up to 36 months

• Treatment interruption

  Up to 36 months

Study Arms (3)

Combination Therapy Group

EXPERIMENTAL

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

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

Monotherapy Group

EXPERIMENTAL

Recombinant Human Interleukin-2 Injections as a monotherapy

Drug: Recombinant Human Interleukin-2 Injections

Control Group

NO INTERVENTION

non-intervention

Interventions

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

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

Combination Therapy Group

Recombinant Human Interleukin-2 Injections DRUG

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

Also known as: Monotherapy Group

Monotherapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

Zhijuan Lin

Xiamen, Fujian, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Lymphopenia

Interventions

Thymalfasin; Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukopenia; Cytopenia; Leukocyte Disorders; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Zhijuan Lin

  The First Aiffiliated hosptical of xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhijuan Lin

CONTACT

15960283462; zjuan_lin@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 4, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)