NCT06584006

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Hematological Malignancy
• Lymphocytopenia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2027-11-30
• Completion: 2028-02-29
• First posted: 2024-09-04
• Last updated: 2024-09-19

Locations

1 site across 1 country: China