Actively Recruiting
The Efficacy of Thalidomide for the Symptomatic Large Granular Lymphocytic Leukemia - a Prospective Phase II Multicenter Clinical Trial From China
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-11-18
48
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of thalidomide as a treatment for symptomatic Large Granular Lymphocytic Leukemia (LGLL), a condition with no current standard first-line therapy. This study follows earlier findings where a combination of thalidomide, prednison, and methotrexate showed promising response rates in LGLL patients. The goal is to observe how effective thalidomide alone is in treating patients with symptomatic LGLL. Participants initially receive oral thalidomide at doses between 50 and 100 mg daily in 4-month cycles. After each cycle, researchers assess the treatment response. If thalidomide alone is effective, it continues for up to three courses. If partial remission is not achieved after the first cycle or complete remission is not reached after the second, methotrexate is added once weekly, continuing for up to three cycles. Treatment stops after a maximum of three cycles or if patients do not respond to the combination therapy. During the study, participants undergo regular evaluations to monitor response, safety, and remission status for up to five years. Researchers will measure overall response rate as the primary outcome and assess safety, complete remission rate, progression-free survival, overall survival, and remission duration as secondary outcomes. The study involves close monitoring of symptoms and laboratory tests to track the treatment's impact over time.
CONDITIONS
Brief Title
Thalidomide for the Symptomatic Large Granular Lymphocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient fully understands the study, voluntarily participates, and signs the informed consent form
- Diagnosis of Large Granular Lymphocytic Leukemia (LGLL)
- Any gender, aged 18 years or older
- Untreated or not properly treated previously, or poor efficacy (not reaching partial remission) or relapsed after treatment without methotrexate/thalidomide-based regimens
- Has indications for LGLL treatment, meeting at least one of: ANC < 0.5 × 10^9/L or neutropenia with recurrent infections; hemoglobin < 100 g/L or requires red blood cell transfusions; platelet count < 50 × 10^9/L; concurrent autoimmune disease needing treatment; symptomatic splenomegaly; severe B symptoms (fever > 38°C, night sweats, or weight loss ≥10% in 6 months); pulmonary hypertension
- ECOG performance status 0-2
- Expected survival of 6 months or more
You will not qualify if you...
- Unable to understand or follow study procedures
- Diagnosed or treated for other malignancies within the past 5 years
- Liver or kidney impairment unrelated to lymphoma (ALT > 3× upper limit, AST > 3× upper limit, bilirubin > 2× upper limit, creatinine clearance < 30 ml/min)
- Other serious medical conditions affecting the study (e.g., uncontrolled diabetes, gastric ulcer, serious heart or lung diseases)
- High risk of thrombosis by Caprini score
- Known HIV infection, active HBV infection, or uncontrolled systemic infections requiring IV antibiotics
- Major surgery within past 14 days or planned during treatment (excluding lymph node biopsy)
- Pregnant or breastfeeding women, or women of childbearing age not using contraception
- Hypersensitivity to study drugs or components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants receive oral thalidomide monotherapy for 4 months. After evaluation, treatment may continue with thalidomide alone or combined with methotrexate weekly depending on response, for up to 3 cycles of 4 months each.
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
L
Lugui Qiu, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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