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Can a shorter chemo regimen work just as well for some lymphoma patients?

NCT ID NCT05018520

Disease control Sponsor: Ruijin Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether 4 cycles of R-CHOP followed by 4 cycles of rituximab is as safe and effective as the standard 6 cycles of R-CHOP plus 2 cycles of rituximab for people with newly diagnosed, low-risk diffuse large B-cell lymphoma. The study plans to enroll 640 participants who have already responded well to 4 cycles of R-CHOP. The main goal is to see if the shorter chemo schedule can reduce side effects without increasing the risk of the cancer coming back within two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) and rituximab
What this could lead to
If successful, this could show that a shorter initial chemo regimen with extra rituximab is just as effective, reducing side effects for low-risk patients.
What could go wrong
This is a phase 3 trial, but it only includes low-risk patients who already responded to 4 cycles, so results may not apply to others. There is still a risk of relapse or side effects from the drugs.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 640 people

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

Started

Sep 2021

Expected to finish

Jun 2028

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

14 to 75 years

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: * Pathologically confirmed CD20 positive DLBCL based on 2016 WHO classification who achieved CR after 4 cycles of RCHOP therapy (examined by PET-CT, Deauville score 1-2) * Treatment naïve * IPI=0,1 * Age ≥ 14 or ≤75 years * non-mass (The length of the lesion\<7.5cm) * ECOG=0,1 * Life expectancy\>6 months * Informed consented Exclusion Criteria: * Have received systemic or local treatment including chemotherapy in the past * Have received autologous stem cell transplantation in the past * Past medical history of other malignant tumors, except basal cell carcinoma of the skin and cervical cancer in situ * Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases, severe infectious diseases and other diseases * Primary skin, primary central nervous system lymphoma * Left ventricular ejection fraction ≦50% * Other concurrent and uncontrolled situation which will affect the patient's medical status based on researchers decision * Laboratory test value during screening: (unless it is caused by lymphoma) Neutrophils \<1.5\*109/L Platelet\<80\*109/L Hemoglobin \<100g/L ALT or AST is 2 times higher than the upper limit of normal, AKP and bilirubin are 1.5 times higher than the upper limit of normal E. Creatinine level is higher than 1.5 times the upper limit of normal * Psychiatric patients or other patients who are known or suspected to be unable to fully accomplish with the research protocol * Pregnant or lactating women * Patients with positive HbsAg test results need to undergo HBV-DNA test and can be admitted to the group after turning negative. In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV-DNA is also required；if the result is positive, patients also need to be treated to become negative before entering the group * Patients living with HIV * Patients with TP53 mutations or those who have not undergone DLBCL hot spot gene screening

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse large B-cell lymphoma

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

  • Ruijin Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200020, China

More trials for these conditions

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