Rocbrutinib plus R-GemOx for relapsed/refractory DLBCL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label phase Ib trial evaluating the safety, tolerability, preliminary activity, and pharmacokinetics of Rocbrutinib (LP-168) with R-GemOx in relapsed/refractory non-GCB DLBCL. It uses a classic 3+3 dose-escalation design to identify safe dose combinations, followed by a potential expansion phase based on safety and early signals of activity. The study will determine appropriate dosing and gather initial evidence on how the combination affects the disease and patients’ biology. Eligible participants have measurable disease, adequate organ function, and no immediate plans for stem cell transplant or CAR-T therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with relapsed or refractory non-GCB DLBCL.
* Have at least one measurable lesion according to the Lugano Response Criteria 2014.
* ECOG performance status 0-2 (0-1 for dose escalation part).
* Life expectancy ≥ 12 weeks.
* Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function.
* No plan for autologous/allogeneic hematopoietic stem cell transplantation or chimeric antigen receptor T-cell (CAR-T) therapy.
* Toxicities from prior anti-tumor therapy have recovered to Grade ≤1 according to NCI CTCAE v5.0.
* All male subjects and female subjects of childbearing potential must strictly use medically approved contraception throughout the entire study period. All male subjects must also avoid sperm donation during the above period. For women of childbearing potential, the result of serum pregnancy test must be obtained. Women must be non-lactating
* Subjects must provide adequate tissue and blood samples for exploratory study. Participation is voluntary, requiring signed informed consent and compliance with the treatment regimen and visit schedule.

Exclusion Criteria:

* Intolerance to Rocbrutinib or any drug in the combination regimen.
* Prior treatment with a BTK-targeted therapy; prior treatment with R-GemOx.
* DLBCL transformed from an indolent lymphoma; diagnosis of high-grade or double-hit DLBCL.
* Chemotherapy, biologic therapy (except CAR-T), immunotherapy or major surgery within 4 weeks of the first dose of study treatment.
* Small molecule targeted therapy within 4 weeks or within 5 half-lives (whichever is shorter) of the first dose of study treatment.
* Herbal or proprietary Chinese medicines with antitumor activity or radiotherapy with a limited field of radiation within 7 days of the first dose of study treatment.
* History of allogeneic hematopoietic stem-cell transplantation (allo-HSCT) or other organ transplantation, or autologous HSCT (auto-HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 90 days of the first dose of study treatment.
* Current corticosteroid therapy at a dose \>20 mg/day prednisone equivalent. The prednisone-equivalent dose must have been stable for at least 4 weeks before Cycle 1 Day 1.
* Unable to discontinue prohibited medications during the study period (strong or moderate CYP3A inhibitors or inducers, P-gp inhibitors, OATP1B3-sensitive substrates, warfarin or other vitamin K antagonists).
* Known or suspected CNS involvement by lymphoma.
* Presence of peripheral neuropathy \> Grade 1.
* Any severe and/or uncontrolled systemic disease, or condition affecting drug swallowing or absorption, that in the investigator's judgment makes the subject unsuitable for the study.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Qingqing Cai
• Email: caiqq@sysucc.org.cn
• Phone: 086-20-87343355

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.