New drug combo aims to boost lymphoma treatment

NCT ID NCT07712588

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Aug 06, 2026 · Updated 2 times

Summary

This trial tests whether adding an experimental drug called birelentinib to standard chemotherapy (R-CHOP) improves outcomes for people with newly diagnosed diffuse large B-cell lymphoma (DLBCL). Participants receive either birelentinib plus R-CHOP or a placebo plus R-CHOP. The study measures safety and how long the cancer stays under control.

What this could mean

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

Active substance
an experimental drug called birelentinib combined with standard chemotherapy (R-CHOP)
What this could lead to
If successful, this could lead to a more effective first-line treatment for diffuse large B-cell lymphoma, potentially improving survival and remission rates.
What could go wrong
This is an early-to-mid-stage trial, so the drug may not prove more effective than standard therapy and could have unforeseen side effects.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 880 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 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: * Age 18-70 years * ECOG score 0-2 * Pathologically confirmed DLBCL unspecified (DLBCL, NOS) * No prior anti-lymphoma therapy * Ann Arbor Stages II - IV * IPI score ≥ 3, or IPI score 1 - 2 and LDH \> 1.3 × ULN and/or lesion diameter ≥ 7 cm * Adequate bone marrow and organ function * Willing to comply with contraceptive restrictions Exclusion Criteria: * Indolent lymphoma or Richter transformation, primary mediastinal lymphoma, lymphoma invading the central nervous system or high-grade lymphoma with MYC and BCL2 rearrangements. * Vaccination with live attenuated vaccines or viral vector vaccines within 4 weeks prior to treatment. * Taking vitamin K antagonists, taking 2 or more antiplatelet/anticoagulant drugs at the same time, drugs/herbs or supplements known to potently induce or inhibit CYP3A enzyme activity, anti-tumor traditional Chinese medicine. * Major surgery within 4 weeks or anticipated surgery after the start of this study. * Clinically significant cardiac disorders. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months. * Active infectious diseases. * Peripheral neuropathy ≥ Grade 2 (as defined by CTCAE version 6.0) * Intractable nausea and vomiting that cannot be well controlled by supportive treatment, chronic gastrointestinal diseases, dysphagia, or previous surgical resection of the intestinal segment may affect the adequate absorption of the drug. * Diagnosed with other malignant diseases other than B-cell lymphoma within the past 2 years. * Patients with severe or uncontrolled systemic diseases, including poorly controlled hypertension and active bleeding constitution. * Patients with a history of hypersensitivity to any component of the R-CHOP regimen, DZD8586 drug excipients, or other chemical analogues. * Serious medical or psychiatric illness that could affect participation in the study or could compromise the ability to consent. * Women who are pregnant or breastfeeding.

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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

    5 sites. 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

  • Cancer Hospital of Shandong Frist Medical University

    Jinan, Shangdong, China

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, China

  • Hunan Cancer Hospital

    Changsha, Hunan, China

  • Shanghai Jiao Tong University School of Medicine, Ruijin Hospital

    Shanghai, Shanghai Municipality, China

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