TPM Regimen (Thalidomide, Prednisone and Methotrexate) in LGLL

• Status: Recruiting
• Trial end date: 2025-05-20
• Target enrollment: 0
• Participant gender: All

Summary

Large granular lymphocytic leukemia (LGLL) is a lymphoproliferative disease, with LGL infiltration in peripheral blood and bone marrow, hepatosplenomegaly, and cytopenia. Both T-LGLL and CLPD-NK are indolent disease and share similar biology and clinical course, and treated under the same strategy. So the investigators put them together as LGLL. The investigators used TPM regimen (thalidomide + prednison + methotrexate ) to treat LGLL since 2013, and 18/20 patients (90%) obtained clinical response, including 80% complete response. Adverse events (AE) of grade 3 and above are rare and safe. Therefore, the investigators designed this multicenter clinical trial to validate the efficacy of the TPM regimen in symptomatic T-LGLL and CLPD-NK.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital
• Collaborators: Central South University; First Affiliated Hospital of Guangxi Medical University; First Hospital of Jilin University; Henan Cancer Hospital; The First Affiliated Hospital of Nanchang University; The First Hospital of Jilin University; Tianjin First Central Hospital
• Treatments: Methotrexate; Prednisone; Thalidomide

Criteria

Inclusion Criteria:

1. The gender of the patient is not limited, and the age is ≥18 years old;

2. Must meet diagnostic criteria of T-LGLL or CLPD-NK according to WHO 2016 version;

3. The patient is treatment naive or received single methotrexate less than 4 weeks and without response. If relapsed or refractory patients, the patients must be naive for both thalidomide and methotrexate.

4. With LGLL treatment indications, it mainly includes (meets at least one of the following conditions):

1. ANC <0.5 × 10^9 / L

2. HGB <100g / L or need red blood cell infusion to maintain

3. PLT <50 × 10^9 / L

4. Combining autoimmune diseases that require treatment

5. symptomatic splenomegaly

6. Severe B symptoms

7. Pulmonary hypertension.

5. ECOG performance status score is 0-2;

6. The patient's expected survival time is ≥ 6 months.

Exclusion Criteria:

1. Unable to understand or follow the research procedure;

2. Co-occurrent malignant tumors that has to be treated or course the symptom;

3. Other serious diseases, such as liver, kidney, heart, lung, nerve or metabolic diseases, may impede the ability of patients to tolerate methotrexate, cyclophosphamide or cyclosporin A;

4. ALAT / ASAT or alkaline phosphatase> 3 times the normal value;

5. Creatinine clearance <60ml / min;

6. Serological evidence of active infection of HIV, hepatitis C or hepatitis B;

7. Ineffective contraception;

8. Positive pregnancy test;

9. Pregnant women.