Actively Recruiting
Thalidomide for the Symptomatic Large Granular Lymphocytic Leukemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-11-18
48
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Thalidomide for the Symptomatic Large Granular Lymphocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient fully understands the study and agrees to participate by signing informed consent
- Diagnosed with Large Granular Lymphocytic Leukemia (LGLL)
- Age 18 years or older
- Untreated, improperly treated, or relapsed after non-methotrexate/thalidomide treatment
- Meets at least one LGLL treatment indication: ANC < 0.5 x 10^9/L or recurrent infections; hemoglobin < 100 g/L or requires blood transfusions; platelets < 50 x 10^9/L; concurrent autoimmune disease needing treatment; symptomatic splenomegaly; severe B symptoms; or pulmonary hypertension
- ECOG performance status of 0 to 2
- Expected survival of 6 months or longer
You will not qualify if you...
- Unable to understand or follow study procedures
- Diagnosed or treated for other malignancies within the past five years
- Liver or kidney impairment unrelated to lymphoma with specific lab thresholds (ALT > 3x ULN, AST > 3x ULN, bilirubin > 2x ULN, creatinine clearance < 30 ml/min)
- Serious uncontrolled medical conditions (e.g., diabetes, gastric ulcer, heart or lung diseases)
- High risk of thrombosis per Caprini score
- Known HIV infection or active HBV infection or uncontrolled systemic infection needing IV antibiotics
- Major surgery within the past 14 days or planned during treatment
- Pregnant or breastfeeding women or women of childbearing potential not using contraception
- Allergy to study drugs or their components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
S
Shuhua Yi, Doctor
CONTACT
L
Lugui Qiu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here