Can a gentler drug cocktail tackle an aggressive lymphoma?

NCT ID NCT07884708

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 38 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

60 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The First Affiliated Hospital with Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210000, China

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