Thalidomide for the Symptomatic Large Granular Lymphocytic Leukemia

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Jul 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of thalidomide as a treatment for a specific type of blood cancer called Large Granular Lymphocytic Leukemia (LGLL). Currently, there is no standard first-line treatment for LGLL, and researchers have previously seen promising results when thalidomide is combined with other medications. In this trial, patients will receive thalidomide alone to see how well it works in improving their symptoms. Eligible participants are adults aged 18 and older who have been diagnosed with LGLL and have certain symptoms that require treatment, like low blood cell counts or significant fatigue.

Participants in the trial will take thalidomide for up to three courses. If they don’t see the desired improvement, another medication may be added. The main goal of the study is to determine how effective thalidomide is by measuring the overall response rate in patients. It's important for interested patients to understand the study and provide their consent to participate. The trial is currently recruiting participants, so those who meet the criteria can consider joining to potentially benefit from this treatment option.

Gender

ALL

Eligibility criteria

• 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.