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 (May 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
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
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.
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