NCT06530576

Thalidomide for the Symptomatic Large Granular Lymphocytic Leukemia

The Efficacy of Thalidomide for the Symptomatic Large Granular Lymphocytic Leukemia - a Prospective Phase Ⅱ Multicenter Clinical Trial From China

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There is currently no standard first-line treatment for LGLL. The investigators used the TPM regimen (thalidomide + prednison + methotrexate ) to treat LGLL since 2020, enrolling a total of 54 patients and achieving an overall response rate (ORR) of 88.9% and a complete response (CR) rate of 75.9%. To further explore this hypothesis, the investigators designed this study to observe the efficacy of thalidomide monotherapy in patients with symptomatic LGLL. The investigators speculate that thalidomide plays a major role in the significant improvement of the TPM regimen compared to the MTX regimen. Patients with LGLL are treated with thalidomide at 50 to 100 mg. If the desired response is not achieved at specific time points, methotrexate is added. Thalidomide monotherapy is administered for up to 3 courses, and the TM regimen can also be used for up to 3 courses. The overall response rate with thalidomide monotherapy serves as the primary study endpoint.

Detailed description

The regimen is an oral treatment with a cycle of 4 months. All patients first receive monotherapy with thalidomide at a dose of 50-100 mg/QN. After 4 months, the efficacy is evaluated. If effective, the monotherapy continues for another 4 months. If complete remission (CR) is achieved, the treatment is consolidated for another 4 months before stopping, for a total of 3 courses. If CR is achieved at any point within the first year, the treatment is consolidated for one more course and then stopped. If partial remission (PR) is not achieved within the first cycle, or CR is not achieved within the second cycle, methotrexate 10 mg/m2 orally once a weekis a is dded for consolidation, with each cycle lasting 4 months. After a maximum of 3 cycles, treatment is stopped. Patients who do not achieve PR after 2 cycles of the TM regimen will be withdrawn from the study, with a maximum of 3 cycles allowed.

Conditions

• T-LGL Leukemia
• NK-LGL Leukemia

Interventions

Type	Name	Description
DRUG	Thalidomide and methotrexate	Thalidomide at a dose of 50-100 mg/QN, Methotrexate 10 mg/m2 orally once a week.

Timeline

• Start date: 2024-08-10
• Primary completion: 2026-06-10
• Completion: 2027-07-01
• First posted: 2024-07-31
• Last updated: 2025-11-18

Locations

1 site across 1 country: China