New drug cocktail aims to tackle tough lymphoma
NCT ID NCT07272499
First seen Jun 24, 2026 · Last updated Jul 29, 2026 · Updated 3 times
Summary
This study is testing a combination of three drugs—orelabrutinib, lisaftoclax, and rituximab—in people with untreated, high-risk mantle cell lymphoma (MCL). The goal is to see how well this treatment shrinks or eliminates cancer. The trial will enroll 25 participants and track response rates, survival, and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Orelabrutinib, lisaftoclax, and rituximab
- What this could lead to
- If successful, this combination could offer a new, effective first-line treatment option for people with high-risk mantle cell lymphoma, potentially improving response rates and survival.
- What could go wrong
- This is a small, early-phase (phase 2) trial with only 25 participants, so results may not apply to everyone. Side effects from the drug combination are possible, and the treatment may not work as hoped.
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 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Sep 2028
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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14 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: * Diagnosed with MCL (mantle cell lymphoma) through flow cytometry or histopathology, and has not received prior treatment. * Age \> 14 years of age, both genders are eligible. * Ann Arbor stage II-IV; for stage II subjects, those who require systemic therapy based on the investigator's judgment are eligible. * At least one measurable lesion. * Any one of the following high-risk factors is present: MIPI score of 6-11, Ki67 \> 30%, TP53 mutation/loss or p53 protein expression \>50%, blastic or pleomorphic variation. * Laboratory tests (blood routine, liver and kidney function) meet the following requirements: a) Blood routine: White blood cell count ≥3.0×10\^9/L, absolute neutrophil count ≥1.5×10\^9/L, hemoglobin ≥90g/L, platelet count ≥75×10\^9/L. b) Liver function: Transaminases ≤2.5 times the upper limit of normal, bilirubin ≤1.5 times the upper limit of normal. c) Serum creatinine 44-133 mmol/L. * The investigator judges that the subject's life expectancy is greater than 12 weeks from the time of screening. * Willing and able to participate in all required assessments and procedures of the study protocol. Exclusion Criteria: * Patients who have previously received treatment with BTK inhibitors. * Patients with severe complications or serious infections. * Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc. * Patients with active infections requiring systemic treatment, including bacterial, fungal, and viral infections. * HIV-infected individuals. * Patients with mental disorders or those who are known or suspected to be unable to fully comply with the study protocol. * Patients whom the investigator judges to have other conditions that make them unsuitable for participation in this study.
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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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Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITINGShanghai, Shanghai Municipality, 200025, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Real-World data may reveal how acalabrutinib performs in chinese blood cancer patients
- Can a drug combo shrink Hard-to-Treat lymphoma tumors?
- Can 'Memory-Enhanced' immune cells outsmart lymphoma?
- Can a chemo-free cocktail tame mantle cell lymphoma?
- Engineered immune cells take on tough lymphomas
- New drug duo aims to outsmart resistant lymphoma