Thalidomide treatment for symptomatic large granular lymphocytic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy of thalidomide monotherapy in patients with symptomatic large granular lymphocytic leukemia (LGLL). Patients will receive thalidomide at doses of 50 to 100 mg daily for up to three treatment cycles, with evaluations for response after each cycle. If partial remission is not achieved, methotrexate will be added to the treatment regimen. The primary endpoint is the overall response rate to thalidomide monotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The patient fully understands the study, voluntarily participates, and signs the informed consent form (ICF);
2. The patient must meet the diagnostic criteria for LGLL;
3. The patient can be of any gender, aged 18 years or older;
4. 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;
5. The patient has indications for LGLL treatment, meeting at least one of the following criteria:

   1. ANC \< 0.5 × 10\^9/L, or neutropenia with recurrent infections
   2. HGB \< 100 g/L or requiring red blood cell transfusions for maintenance
   3. PLT \< 50 × 10\^9/L
   4. Concurrent autoimmune disease requiring treatment
   5. Symptomatic splenomegaly
   6. Severe B symptoms (unexplained fever, temperature over 38°C; night sweats; weight loss of 10% or more within six months)
   7. Pulmonary hypertension;
6. ECOG score of 0-2;
7. The patient's expected survival period is 6 months or more.

Exclusion Criteria:

1. Unable to understand or follow the study procedures;
2. Diagnosed or treated for malignancies other than LGLL within the past five years;
3. 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;
4. 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;
5. Caprini thrombosis analysis score indicating high risk (Appendix 2);
6. 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.
7. 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;
8. Pregnant or breastfeeding women, and women of childbearing age who are not using contraception;
9. Hypersensitivity to the drugs or their components used in the study.

Where it's running

• Institute of Hematology & Blood Diseases Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Shuhua Yi, Doctor — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Shuhua Yi, Doctor
• Email: yishuhua@ihcams.ac.cn
• Phone: 86-22-23909106

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• National longitudinal cohort for large granular lymphocytic leukemia (LGLL)

  This project will collect past and ongoing medical data to test what factors affect diagnosis, treatments, and outcomes for people in China with T-LGL or NK-LGL leukemia.

  Recruiting Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07019766

• Golidocitnib treatment for relapsed indolent T/NK-cell lymphomas

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• Using PI3K inhibitors to treat relapsed indolent T/NK-cell lymphomas

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  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT06530550

• Registry for patients with chronic lymphocytic leukemia and related conditions

  This study is tracking patients with chronic lymphocytic leukemia and similar conditions to see how well different treatments work and what long-term effects they might have.

  Recruiting German CLL Study Group · Dresden, Saxony · NCT02863692

• Zeprumetostat in relapsed/refractory T-cell large granular lymphocytic leukemia

  This study tests whether taking Zeprumetostat by mouth can help people with relapsed or hard-to-treat T-cell large granular lymphocytic leukemia.

  Recruiting Phase 1 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07692529

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.