Actively Recruiting
Phase Ib Study of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-cell Non-Hodgkin Lymphoma
Led by Guangzhou Lupeng Pharmaceutical Company LTD. · Updated on 2025-03-25
112
Participants Needed
1
Research Sites
298 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, multicentre Phase Ib study to evaluate the safety and preliminary efficacy of new generation Bruton Tyrosine Kinase inhibitor Rocbrutinib in combination to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristin, Prednison) in adult patients with newly diagnosed, previously untreated B-cell Non-Hodgkin Lymphoma \[Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL) or Mantle Cell Lymphoma (MCL)\].
CONDITIONS
Official Title
Phase Ib Study of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathological diagnosis of DLBCL, MZL, or MCL (non-GCB subtype required for dose expansion phase) with no prior anti-tumor systemic or local radiation therapy for these diseases
- At least one measurable lesion
- ECOG physical status score of 0 to 2
- Life expectancy of 6 months or more
- International Prognostic Index (IPI) score of 2 or higher (for DLBCL participants in dose expansion phase only)
- Adequate coagulation, liver, kidney, and blood function as defined by specific laboratory criteria
- Negative pregnancy test for women of childbearing potential at screening
- Use of highly effective contraception during the study and for specified periods after the last dose for men and women of childbearing potential
- Voluntary enrollment with signed informed consent and adherence to trial treatment and visits
You will not qualify if you...
- Allergy to Rocbrutinib or any of its ingredients
- Inability to tolerate R-CHOP regimen as assessed by investigator
- Known central nervous system involvement with lymphoma or diagnosis of primary CNS lymphoma or primary mediastinal large B-cell lymphoma
- History of indolent lymphoma such as follicular lymphoma or chronic lymphocytic leukemia (Richter's transformation) or confirmed coexistence of follicular lymphoma
- Prior or expected solid organ or hematopoietic stem cell transplantation
- Major surgery within 4 weeks before study entry or planned during study
- Participation in other non-antitumor or medical device clinical trials within 4 weeks
- Known bleeding disorders or bleeding tendency
- Recent or ongoing treatment with warfarin or equivalent anticoagulants
- Recent treatment or chronic use of strong/moderate CYP3A4 inhibitors or inducers
- Other malignancies within the past 3 years except target indications
- Prior cumulative doxorubicin dose ≥150 mg/m2 or equivalent anthracyclines
- Serious medical conditions including uncontrolled hypertension, heart failure (NYHA class 2 or higher), low heart function, arrhythmias with prolonged QT interval, uncontrolled diabetes, active coronary artery disease, COPD, renal failure, severe liver disease, active infection or bleeding
- Known infections with HIV, syphilis, hepatitis B or C
- Conditions affecting drug swallowing or absorption
- Investigator judgment of unfitness for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yue Shen, Ph D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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