RecruitingPhase 2NCT06530576

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


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

48 participants

Start Date

Aug 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing thalidomide as a treatment for large granular lymphocytic leukemia (LGLL) — a rare, slow-growing blood cancer where abnormal white blood cells accumulate. Thalidomide is being explored to see if it can control the disease and reduce symptoms. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with LGLL - You have an indication for treatment (e.g., low blood counts, recurrent infections, or autoimmune complications) - You are either untreated, or your prior treatment did not include methotrexate or thalidomide, or prior treatment was not effective **You may NOT be eligible if...** - You have already been treated with thalidomide or methotrexate-based regimens - You are pregnant (thalidomide can cause birth defects) - You have serious organ dysfunction - You do not have a clinical indication for treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGThalidomide and methotrexate

Thalidomide at a dose of 50-100 mg/QN, Methotrexate 10 mg/m2 orally once a week.


Locations(1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

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NCT06530576


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