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New treatment option for T-LGL Leukemia
Official title Thalidomide for the Symptomatic Large Granular Lymphocytic Leukemia
ClinicalTrials.gov ID: NCT06530576
What this study is testing
What is Thalidomide and methotrexate?
Thalidomide and methotrexate is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for t-lgl leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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%.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 how well it works (not reaching PR) or relapsed after being treated...
- The patient has indications for LGLL treatment, meeting at least one of the following criteria:
You likely can't join if
- 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...
- Other serious medical conditions that could affect the study (e.g., uncontrolled diabetes, gastric ulcer, other serious heart or lung diseases), with...
- 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...
See the full eligibility criteria
- 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 how well it works (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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.