New drug joins standard chemotherapy in fight against B-Cell lymphoma
NCT ID NCT06251180
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
Researchers are testing whether adding an experimental drug called rocbrutinib to standard R-CHOP chemotherapy is safe and shows early signs of helping adults newly diagnosed with certain B-cell non-Hodgkin lymphomas. The trial enrolls about 112 participants who have not yet received treatment for diffuse large B-cell lymphoma, marginal zone lymphoma, or mantle cell lymphoma. Everyone receives rocbrutinib plus R-CHOP, and researchers track side effects, dose levels, and how well the cancer responds.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rocbrutinib, an experimental Bruton's tyrosine kinase inhibitor, given with standard R-CHOP chemotherapy
- What this could lead to
- If it works, adding rocbrutinib to standard chemotherapy could improve treatment for people newly diagnosed with B-cell non-Hodgkin lymphoma.
- What could go wrong
- This is an early-phase trial with a small number of participants, so safety and effectiveness are not yet established. Adding a new drug to chemotherapy may cause unexpected side effects or may not improve outcomes.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 112 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2024
- Expected to finish
-
Dec 2029
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 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: * Participants was histopathologically diagnosed with any of the following diseases: DLBCL, MZL or MCL (if enrolled in the dose expansion phase, histological confirmation of non-GCB subtype), and have not previously received anti-tumor systemic therapy or local radiation therapy for the above diseases. * Participants must have at least one measurable lesion. * ECOG physical status score 0-2. * Life expectancy ≥6 months. * International Prognostic Index (IPI) score ≥ 2 (only participants with DLBCL in dose expansion portion). * Adequate coagulation, liver, kidney, and hematopoietic functions:PT and APTT \<1.5x ULN; serum bilirubin \<1.5x ULN except in participants with Gilbert's syndrome who must have a serum bilirubin of \<3x ULN, AST and ALT ≤ 3x ULN or \< 5x ULN if hepatic involvement are present; serum creatinine (Scr) ≤1.5 x ULN, or calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula.; ANC≥1500/mm3, hemoglobin≥8.0 g/dL, and platelets \>100,000/mm3 unless deemed related to lymphoma involvement in the bone marrow and felt potentially reversible by the treating physician. * Women of childbearing potential must have a negative serum or urine (beta-human chorionic gonadotropin \[beta-hCG\]) at screening. * Women of childbearing potential and men who are sexually active with a woman of childbearing potential must be practicing a highly effective contraceptive measures of during and after the study (90 days after the last dose of ROCBRUTINIB and 12 months after the last dose of Rituximab). Men must agree to not donate sperm during and for up to 90 days after he last dose of ROCBRUTINIB. * Participants voluntarily enrolled and signed the informed consent form, and followed the trial treatment and visits. Exclusion Criteria: * Participants are allergic to Rocbrutinib or any of its excipients; Participants who are assessed by the investigator as being unable to tolerate the R-CHOP regimen. * Participants with known central nervous system involvement with lymphoma. or diagnosis of primary central nervous system lymphoma (PCNSL) or primary mediastinal large B-cell lymphoma (PMBL). * Participants with DLBCL had a history of indolent lymphoma such as FL or CLL (Richter's transformation), or was histopathologically comfirmed with FL (regardless of grade) coexistentially. * Prior treatment with solid organ transplantation or hematopoietic stem cell transplantation(HSCT) ; expected HSCT during the study. * Major surgery within 4 weeks of study entry or expected major surgery during the study. * Prior another non-antitumor or medical instruments clinical trials within 4 weeks. * Known bleeding diseases (such as von Willebrand's disease or hemophilia A, hemophilia B, etc.), or have bleeding tendency. * Prior treatment with warfarin or equivalent vitamin K antagonists within 14 days; requires anticoagulation with warfarin or equivalent vitamin K antagonists. * Prior treatment with strong/moderate CYP3A4 inhibitors within 5 days or prior foods with inhibitory effects on CYP3A4 within 3 days at screening; requires chronic treatment with moderate/strong CYP3A inhibitors or inducers, or OATP1B1/OATP1B3 sensitive substrates during the study. * Participants with other malignancies other than the target indications of this study within the past three years. * Prior treatment with the cumulative dose of doxorubicin ≥150 mg/m2 (or other anthracyclines at doses converted based on cumulative cardiac toxicity) * Any serious medical condition including but not limited to uncontrolled hypertension, uncontrolled congestive heart failure or ≥Class 2 cardiac disease as defined by the New York Heart Association Functional Classification or LVEF less than 40%, uncontrolled or symptomatic arrhythmias with corrected QT interval (QTc) \> 480 msec, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, COPD, renal failure, severe hepatic disease, uncontrolled active infection, active hemorrhage. * Known HIV infection, or syphilis infection, or hepatitis B DNA or hepatitis C RNA positive. * Known diseases that affect drug swallowing or absorption. * Unfit to participate in this study in the investigator's opinion.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for B-cell non Hodgkin lymphoma are added.
By submitting, you agree to our Terms of use
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.
Contacts and locations
Locations
-
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Two-Drug combo targets tough Non-Hodgkin's lymphoma
- Triple drug combo targets mantle cell lymphoma
- New drug BL-M08D1 joins standard therapy in fight against aggressive lymphoma
- Can AI spot the lymphoma patients who Won't respond?
- Outpatient immunotherapy tested for hard-to-treat lymphomas