Old drug, new hope? thalidomide trial targets rare leukemia
NCT ID NCT06530576
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests thalidomide, a drug once used for other conditions, in 48 people with symptomatic large granular lymphocytic (LGL) leukemia. Participants start on thalidomide alone; if it doesn't work well enough, methotrexate is added. The goal is to see if thalidomide can control the disease and improve blood counts, offering a potential new treatment for this rare leukemia.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- thalidomide (with methotrexate added if needed)
- What this could lead to
- If this works, it could point toward a new first-line treatment for LGL leukemia that is simpler and possibly safer than current options.
- What could go wrong
- This is a small, early-phase trial with only 48 people. Thalidomide has known side effects, and the results may not apply to all patients or lead to a standard therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institute of Hematology & Blood Diseases Hospital
RECRUITINGTianjin, Tianjin Municipality, 300020, China
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