OncoMatch/Clinical Trials/NCT06251180
Phase Ib Study of Rocbrutinib in Combination with R-CHOP in Patients with Newly Diagnosed B-cell Non-Hodgkin Lymphoma
Is NCT06251180 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments for b-cell non-hodgkin lymphoma.
Treatment: Rocbrutinib · Rituximab · Cyclophosphamide · doxorubicin · Vincristin · Prednisone — 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 \[Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL) or Mantle Cell Lymphoma (MCL)\].
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: anti-tumor systemic therapy
have not previously received anti-tumor systemic therapy or local radiation therapy for the above diseases
Cannot have received: local radiation therapy
have not previously received anti-tumor systemic therapy or local radiation therapy for the above diseases
Cannot have received: hematopoietic stem cell transplantation
Prior treatment with solid organ transplantation or hematopoietic stem cell transplantation(HSCT); expected HSCT during the study.
Cannot have received: solid organ transplantation
Prior treatment with solid organ transplantation or hematopoietic stem cell transplantation(HSCT); expected HSCT during the study.
Cannot have received: anthracycline (doxorubicin)
Exception: cumulative dose ≥150 mg/m2 (or other anthracyclines at doses converted based on cumulative cardiac toxicity)
Prior treatment with the cumulative dose of doxorubicin ≥150 mg/m2 (or other anthracyclines at doses converted based on cumulative cardiac toxicity)
Cannot have received: warfarin or equivalent vitamin K antagonists
Exception: within 14 days; requires anticoagulation with warfarin or equivalent vitamin K antagonists
Prior treatment with warfarin or equivalent vitamin K antagonists within 14 days; requires anticoagulation with warfarin or equivalent vitamin K antagonists.
Cannot have received: strong/moderate CYP3A4 inhibitors
Exception: 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
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.
Cannot have received: other clinical trial therapy
Exception: within 4 weeks
Prior another non-antitumor or medical instruments clinical trials within 4 weeks.
Lab requirements
Blood counts
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
Kidney function
serum creatinine (Scr) ≤1.5 x ULN, or calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula
Liver function
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
Cardiac function
LVEF less than 40%, uncontrolled or symptomatic arrhythmias with corrected QT interval (QTc) > 480 msec, uncontrolled congestive heart failure or ≥Class 2 cardiac disease as defined by the New York Heart Association Functional Classification
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06251180 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages