New drug combo aims to boost lymphoma treatment
NCT ID NCT07712588
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 880 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2032
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- 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: * 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.
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The places running it
5 sites. 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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Cancer Hospital of Shandong Frist Medical University
Jinan, Shangdong, China
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Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
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Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
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Hunan Cancer Hospital
Changsha, Hunan, China
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Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
Shanghai, Shanghai Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Proton beams vs. X-Rays: can a pricier radiation spare hearts and prevent second cancers?
- Can 'Memory-Enhanced' immune cells outsmart lymphoma?
- Can a Two-Drug combo keep aggressive lymphoma at bay?
- Can a 'Universal' cancer target outsmart resistant blood cancers?
- Can a single shot build a cancer army inside the body?
- Can a smart immune cell with a kill switch beat tough lymphomas?