Status:
RECRUITING
Thalidomide for the Symptomatic Large Granular Lymphocytic Leukemia
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
T-LGL Leukemia
NK-LGL Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 patient...
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, t...
Eligibility Criteria
Inclusion
- The patient fully understands the study, voluntarily participates, and signs the informed consent form (ICF);
- The patient must meet the diagnostic criteria for LGLL;
- The patient can be of any gender, aged 18 years or older;
- The patient is either untreated or not properly treated previously, or has poor efficacy (not reaching PR) or relapsed after being treated with regimens not based on methotrexate/thalidomide;
- The patient has indications for LGLL treatment, meeting at least one of the following criteria:
- ANC \< 0.5 × 10\^9/L, or neutropenia with recurrent infections
- HGB \< 100 g/L or requiring red blood cell transfusions for maintenance
- PLT \< 50 × 10\^9/L
- Concurrent autoimmune disease requiring treatment
- Symptomatic splenomegaly
- Severe B symptoms (unexplained fever, temperature over 38°C; night sweats; weight loss of 10% or more within six months)
- Pulmonary hypertension;
- ECOG score of 0-2;
- The patient's expected survival period is 6 months or more.
Exclusion
- Unable to understand or follow the study procedures;
- Diagnosed or treated for malignancies other than LGLL within the past five years;
- Non-lymphoma-related liver or kidney function impairment: ALT \> 3 times the upper limit of normal (ULN), AST \> 3 times the ULN, total bilirubin (TBIL) \> 2 times the ULN, serum creatinine clearance \< 30 ml/min;
- Other serious medical conditions that could affect the study (e.g., uncontrolled diabetes, gastric ulcer, other serious heart or lung diseases), with the judgment resting with the investigator;
- Caprini thrombosis analysis score indicating high risk (Appendix 2);
- Known history of HIV infection or active HBV infection, or any uncontrolled active systemic infection requiring intravenous antibiotics; Note: Active HBV infection is defined as: a. HBV DNA ≥ 2000 IU/ml; b. ALT ≥ 2 times the ULN; c. Exclusion of hepatitis due to the disease itself, drugs, or other causes. All three conditions must be met. If a patient initially has active HBV infection and turns into inactive HBV infection after anti-HBV treatment, they can be included in the study provided they receive adequate anti-HBV treatment.
- Patients who have undergone major surgery (excluding lymph node biopsy) within the past 14 days or are expected to undergo major surgery during the treatment;
- Pregnant or breastfeeding women, and women of childbearing age who are not using contraception;
- Hypersensitivity to the drugs or their components used in the study.
Key Trial Info
Start Date :
August 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06530576
Start Date
August 10 2024
End Date
July 1 2027
Last Update
November 18 2025
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020