Can a gentler drug cocktail tackle an aggressive lymphoma?
NCT ID NCT07884708
First seen Oct 20, 2026 · Last updated Oct 21, 2026 · Updated 1 time
Summary
Researchers are testing a combination of chidamide, lenalidomide and rituximab in older or frail adults newly diagnosed with double-expressor DLBCL, an aggressive form of lymphoma. The study enrolls people aged 70 and older, or 60 and older with other health conditions that make standard chemotherapy hard to tolerate. Participants receive the three drugs as induction therapy, and those who respond continue with chidamide and lenalidomide for up to a year. The main goal is to see how long participants live without their disease worsening, and to track safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a three-drug combination of chidamide, lenalidomide and rituximab
- What this could lead to
- If the combination works, it could offer older or frail adults with double-expressor DLBCL a treatment option that avoids standard intensive chemotherapy.
- What could go wrong
- This is a small, single-arm Phase 2 study with no comparison group, so early results may not hold up in larger trials. The drugs can cause side effects, and some participants may not respond.
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 38 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Mar 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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60 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: * Histopathologically confirmed, previously untreated DLBCL; * Age ≥70 years, or ≥60 years with comorbidities (including reduced left ventricular ejection fraction, history of myocardial infarction \[\>6 months prior to enrollment\], exertional angina, arrhythmia \[Grade ≤2\], hypertension or diabetes requiring treatment), or ECOG PS ≥2 deemed ineligible for standard chemotherapy; * At least one measurable lesion, defined as: Nodal lesion: Longest diameter \>1.5 cm, or Extranodal lesion: Longest diameter \>1.0 cm, with two perpendicular dimensions accurately measurable; * ECOG PS ≤3; * Estimated life expectancy ≥3 months * MYC and BCL2 protein co-expression confirmed by immunohistochemistry (double-expressor lymphoma) * Voluntary participation; full understanding of the study with signed informed consent; willingness and ability to comply with all study procedures Exclusion Criteria: * Pregnant or lactating women, and patients of childbearing potential unwilling to use contraception; * Recipients of organ transplantation; * Uncontrolled coagulopathy or active bleeding; * Uncontrolled cardiocerebrovascular diseases (including LVEF \<50%), connective tissue diseases, or severe active infections; * Major organ surgery within 6 weeks prior to screening; * Laboratory abnormalities at screening (unless lymphoma-related): Neutrophils \<1.5×10⁹/L; Platelets \<80×10⁹/L (\<50×10⁹/L if bone marrow involvement); Liver dysfunction: Total bilirubin \>1.5×ULN, ALT/AST \>2.5×ULN (or \>5×ULN with liver involvement); Renal dysfunction: Serum creatinine \>1.5×ULN; * HBV infection: HBsAg-positive patients: Eligible if HBV DNA \<10³ IU/mL; HBsAg-negative but HBcAb-positive (regardless of HBsAb status): Eligible if HBV DNA \<10³ IU/mL; * HIV infection; * Central nervous system lymphoma involvement; * Concurrent antitumor therapy (for lymphoma or other malignancies); * Substance abuse or chronic alcoholism affecting outcome evaluation; * Psychiatric disorders or other conditions compromising protocol compliance; * Concurrent use of strong/moderate CYP3A4 inhibitors/inducers: Excluded if taken within 7 days prior to treatment (or \<5 half-lives); * Inability to swallow capsules or significant gastrointestinal dysfunction (e.g., malabsorption, bariatric surgery, IBD, bowel obstruction); * Other uncontrolled conditions deemed by investigators to: Jeopardize patient safety; Interfere with drug absorption/metabolism; Pose excessive risk to study outcomes
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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 with Nanjing Medical University
RECRUITINGNanjing, Jiangsu, 210000, China
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