Clinical trial · Interventional
TPM Regimen (Thalidomide, Prednisone and Methotrexate) in LGLL
The Efficacy of Thalidomide Plus Prednisone and Methotrexate for the Symptomatic Large Granular Lymphocytic Leukemia - a Prospective Multicenter Clinical Trial From China
NCT04453345CI-TRIAL-00045762unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clpd-Nk | Chronic Lymphoproliferative Disorder of NK-Cells | ALIAS | 0.90 |
| T-LGL Leukemia | T-Cell Large Granular Lymphocyte Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| thalidomide + prednisone + methotrexate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TPM regimen
- description
- thalidomide 50-100mg daily at bedtime + prednisone 0.5mg/kg qod to 1mg/kg qd + methotrexate 10mg/m2 per week. 4 months one cycle, up to 3 cycles. After get partial remission, thalidomide maintenance will continue up to 2 years.
- interventionNames
- Drug: thalidomide + prednisone + methotrexate
Primary outcomes (1)
- measure
- Complete response (CR) rate of TPM regimen
- timeFrame
- From date of TPM treatment until the date of complete response, assessed up to 100 months
- description
- Hb\> 120g / L，platelet\> 100×109 / L，ANC \> 1.5×109 / L），ALC\< 4×109 / L，peripheral LGL in normal（\< 0.5×109 / L）
Secondary outcomes (4)
- measure
- Overall response (PR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDDinmohamed AG, Brink M, Visser O, Jongen-Lavrencic M. Population-based analyses among 184 patients diagnosed with large granular lymphocyte leukemia in the Netherlands between 2001 and 2013. Leukemia. 2016 Jun;30(6):1449-51. doi: 10.1038/leu.2016.68. Epub 2016 Apr 8. No abstract available. PMID 27055870
- BACKGROUNDMatutes E. Large granular lymphocytic leukemia. Current diagnostic and therapeutic approaches and novel treatment options. Expert Rev Hematol. 2017 Mar;10(3):251-258. doi: 10.1080/17474086.2017.1284585. Epub 2017 Jan 29. PMID 28128670
- BACKGROUNDMoignet A, Lamy T. Latest Advances in the Diagnosis and Treatment of Large Granular Lymphocytic Leukemia. Am Soc Clin Oncol Educ Book. 2018 May 23;38:616-625. doi: 10.1200/EDBK_200689. PMID 30231346
- BACKGROUNDZambello R, Teramo A, Gattazzo C, Semenzato G. Are T-LGL Leukemia and NK-Chronic Lymphoproliferative Disorder really two distinct diseases? Transl Med UniSa. 2014 Feb 4;8:4-11. eCollection 2014 Jan. PMID 24778993
- BACKGROUNDCheon H, Dziewulska KH, Moosic KB, Olson KC, Gru AA, Feith DJ, Loughran TP Jr. Advances in the Diagnosis and Treatment of Large Granular Lymphocytic Leukemia. Curr Hematol Malig Rep. 2020 Apr;15(2):103-112. doi: 10.1007/s11899-020-00565-6. PMID 32062772
- BACKGROUNDLamy T, Moignet A, Loughran TP Jr. LGL leukemia: from pathogenesis to treatment. Blood. 2017 Mar 2;129(9):1082-1094. doi: 10.1182/blood-2016-08-692590. Epub 2017 Jan 23. PMID 28115367
- DERIVEDYu Y, Li Y, Cui R, Yan Y, Li F, Chen Y, Wang T, Hu X, Feng Y, Yu T, Huang Y, Sun J, Lyu R, Xiong W, Wang Q, Liu W, An G, Sui W, Xu Y, Huang W, Zou D, Wang H, Xiao Z, Wang J, Qiu L, Yi S. Thalidomide-based regimen shows promising efficacy in large granular lymphocytic leukemia: a multicenter phase II study. Signal Transduct Target Ther. 2025 Mar 12;10(1):85. doi: 10.1038/s41392-025-02164-4.