Thalidomide for the Symptomatic Large Granular Lymphocytic Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Thalidomide and methotrexate
DrugThalidomide at a dose of 50-100 mg/QN, Methotrexate 10 mg/m2 orally once a week.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: ThalidomideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall response rate
complete remission rate+ partial remission rate
Time frame
up to 5 yearsSecondary outcomes
1
The safety of thalidomide
Incidence of adverse events, serious adverse events and significant adverse event
Time frame
up to 5 years2
Complete remession rate
Hematological PR was defined as an improvement in blood counts ANC \> 0.5 × 109/L; HGB increased by \>1 g/dL; PLT \> 50 × 109/L
Time frame
up to 5 years3
The rate of improvement in efficacy after TM combination
The effectiveness of the TM regimen is measured by subtracting the response rate of single-agent thalidomide
Time frame
up to 5 years4
Progression-free survival
Progression-free survival
Time frame
up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov