New Risk-Adapted drug combo aims to outsmart lymphoma
NCT ID NCT06793189
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tests a personalized approach to treating marginal zone lymphoma, a slow-growing blood cancer. Researchers assign patients to different drug combinations based on their risk score, using targeted therapies like obinutuzumab, orelabrutinib, and lenalidomide. The goal is to improve how long the cancer stays away while keeping side effects manageable. About 145 newly diagnosed patients who need systemic treatment will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- obinutuzumab, orelabrutinib, and lenalidomide
- What this could lead to
- If successful, this could provide a more personalized, effective treatment for marginal zone lymphoma, potentially improving long-term disease control and reducing side effects.
- What could go wrong
- This is a Phase 2 trial with only 145 participants, so results may not apply to everyone. The drugs can cause serious side effects like infections, low blood counts, and organ toxicity.
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 145 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 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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18 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: * 1\. Histopathologically confirmed CD20-positive marginal zone lymphoma (according to the 2016 WHO classification). 2\. Age ≥ 18 years old, regardless of gender. 3. MZL patients requiring systemic treatment, including but not limited to: 1. Helicobacter pylori (HP)-positive or HP - negative gastric mucosa extranodal marginal zone lymphoma (MALT) patients with progression/relapse after local treatment (including surgery, radiotherapy, and anti - Helicobacter pylori treatment). 2. Non - gastric MALT patients with Ann Arbor stage I - II who have progression/relapse after local treatment (including surgery, radiotherapy, etc.), or untreated patients with Ann Arbor stage III - IV who meet the GELF criteria recommended by the NCCN guidelines. 3. Splenic marginal zone lymphoma (SMZL) patients with progression/relapse after local treatment (including splenectomy, antiviral treatment for HCV - positive patients, etc.), or untreated patients meeting the criteria of progressive or painful splenomegaly, symptomatic or progressive cytopenia such as HB \< 100g/L, PLT \< 80×10⁹/L, absolute neutrophil count (ANC) \< 1.0×10⁹/L. 4. Nodal marginal zone lymphoma (NMZL) patients with Ann Arbor stage I - II who have progression/relapse after local treatment (including surgery, radiotherapy, etc.), or untreated patients with Ann Arbor stage III - IV who meet the GELF criteria recommended by the NCCN guidelines. 4\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 5. Life expectancy of at least 3 months. 6. The patient has adequate bone marrow (except those caused by MZL), liver and kidney functions. 7\. Able to comply with the research procedures and cooperate in the implementation of the entire research process; 8. Written informed consent; 9. Women with fertility agree to take appropriate measures to avoid pregnancy during the treatment period until at least one year after the end of treatment; Men agree to maintain abstinence or use barrier contraception. Exclusion Criteria: * 1\. Histologically transformed into high-grade lymphoma. 2. Known central nervous system involvement of MZL. 3. Previous systemic treatment including immunotherapy, chemotherapy or targeted drugs. 4\. Previous autologous stem-cell transplantation or allogeneic tissue/solid organ transplantation. 5\. History of other invasive cancers within the past 3 years that have not received curative treatment or are still receiving anti-cancer treatment (including hormonal therapy for breast or prostate cancer). 6\. Complicated with uncontrolled cardiovascular and cerebrovascular diseases (such as New York Heart Association-defined grade 3 or 4 heart failure, arrhythmia, myocardial infarction, stroke, or intracranial hemorrhage), coagulation - disorder diseases, connective tissue diseases, severe infectious diseases (including active pulmonary tuberculosis), etc. 7\. Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection (positive result shown by polymerase chain reaction \[PCR\]). Serological antibody - positive is allowed if HBV DNA \< 10³ IU/ml; HCV RNA test must be negative. 8\. Vaccinated with live attenuated vaccines within 4 weeks before starting investigational treatment. During the study, patients are prohibited from receiving live attenuated vaccine inoculations, including influenza vaccines. 9\. Requiring continuous treatment with potent and moderate-effect CYP3A inhibitors or CYP3A inducers. 10\. Unable to swallow capsules or having diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction. 11\. Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol. 12\. Pregnant or lactating women. 13. Other concurrent and uncontrolled medical conditions that, in the investigator's opinion, will affect the patient's participation in the 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
3 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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Affiliated First Hospital of China Medical University
RECRUITINGShenyang, Liaoning, China
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Peking University Third Hospital
RECRUITINGBeijing, China
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Shanghai Ruijin Hospital
RECRUITINGShanghai, China, 200025, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New drug takes aim at Hard-to-Treat blood cancers
- CAR-T therapy Follow-Up study shows no new safety surprises
- New combo therapy aims to shrink lymphoma tumors in untreated patients
- New combo therapy aims to wipe out lymphoma without prior treatment
- Experimental drug voruciclib tested in desperate blood cancer patients