New cocktail therapy takes on tough lymphoma
NCT ID NCT05182957
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether combining an immunotherapy drug (anti-PD-1) with two chemotherapy-like drugs (lenalidomide and azacitidine) can shrink tumors in people with peripheral T-cell lymphoma that has come back or not responded to prior treatment. About 31 participants will receive the three drugs in cycles. The main goal is to see how many patients achieve a complete or partial response after six cycles.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anti-PD-1 monoclonal antibody, lenalidomide, and azacitidine
- What this could lead to
- If successful, this combination could offer a new treatment option for patients with hard-to-treat peripheral T-cell lymphoma that has not responded to standard therapies.
- What could go wrong
- This is a small, early-phase (phase 2) trial with only 31 participants, so results may not apply broadly. The drug combination may cause significant side effects, and it is not a cure—patients may still need ongoing treatment.
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 31 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2020
- Expected to finish
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Jun 2026
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. Pathological immunohistochemistry or flow cytometry confirmed that R/R PTCL with measurable (diameter greater than 1.5cm) lesions meets any of the following conditions: 1\> After 4 courses of standard first-line therapy or 2 courses of more than two-line therapy, the lesions were reduced by \<50%; 2\> PTCL with disease progression after first-line or induction therapy; 3\> After hematopoietic stem cell transplantation, new lesions appear or the size of previously affected lesions increased by more than 50%. 2. Age ≥ 18 years. 3. ECOG≤2分. 4. The main organ functions need to meet the following conditions:Hemogram needs to meet HB ≥70\*1012/L,PLT≥50\*109/L,NE≥1\*109/L;LVEF≥50%;CR≤132umol/l or CCr≥60 ml/min;ALT and AST≤2 times normal range;Lung function≤Level 1;dyspnea(CTCAE v5.0),and blood oxygen saturation without oxygen absorption\> 91%. 5. Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up one year period of the study. 6. Estimated survival time ≥3 months. 7. Voluntary signing of informed consent. Exclusion Criteria: 1. Accepted major surgery within 4 weeks before treatment. 2. Prior malignancy (other than Relapsed/Refractory Peripheral T-cell Lymphoma), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer,malignant tonsilloma or carcinoma in situ; 3. Patients who have previously received failed allogeneic hematopoietic stem cell transplantation. 4. Have stroke or intracranial hemorrhage within 3 months. 5. Evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at serious risk:significant cardiovascular disease(class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification、myocardial infarction within 6 months of screening、uncontrolled or symptomatic arrhythmias) and/or significant lung disease. 6. HIV infection and/or active hepatitis B or active hepatitis C. 7. Uncontrolled systemic infection. 8. Pregnant or breasting-feeding women. 9. According to the researchers' judgment, any life-threatening disease, medical condition or organ system dysfunction which can endanger the patient's safety and Interfer with the absorption or metabolism of anti-PD-1 monoclonal antibody plus Lenalidomide and Azacitidine,may put the results of a study at unnecessary risk.
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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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The First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, 215000, China
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Other studies related to the condition(s) this trial covers.
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