{"id":"orelabrutinib-r-chop","safety":{"commonSideEffects":[{"rate":"30-50%","effect":"Neutropenia"},{"rate":"20-40%","effect":"Anemia"},{"rate":"20-40%","effect":"Thrombocytopenia"},{"rate":"10-30%","effect":"Fatigue"},{"rate":"10-30%","effect":"Nausea"}]},"_chembl":{"chemblId":"CHEMBL4650321","moleculeType":"Small molecule","molecularWeight":"427.50"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Orelabrutinib works by selectively inhibiting the BTK enzyme, which is involved in the activation of B cells. R-CHOP is a combination of chemotherapy drugs that target rapidly dividing cancer cells. The combination of orelabrutinib and R-CHOP is used to treat certain types of non-Hodgkin lymphoma.","oneSentence":"Orelabrutinib is a Bruton's tyrosine kinase (BTK) inhibitor, and R-CHOP is a chemotherapy regimen that includes rituximab, cyclophosphamide, doxorubicin, and prednisone.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:24:45.563Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Treatment of relapsed or refractory mantle cell lymphoma"}]},"trialDetails":[{"nctId":"NCT07372365","phase":"PHASE2","title":"Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve MZL.","status":"RECRUITING","sponsor":"The First Affiliated Hospital of Soochow University","startDate":"2025-10-24","conditions":"Marginal Zone Lymphoma (MZL)","enrollment":23},{"nctId":"NCT06901999","phase":"PHASE2","title":"Methotrexate or Thiotepa Combined With R-CHOP and Orelabrutinib in CNSL Patients","status":"NOT_YET_RECRUITING","sponsor":"Ruijin Hospital","startDate":"2025-04","conditions":"CNS Lymphoma","enrollment":23},{"nctId":"NCT06701357","phase":"PHASE2","title":"CR-CHOP+X in Previously Untreated DEL","status":"RECRUITING","sponsor":"Ruijin Hospital","startDate":"2024-12-10","conditions":"DLBCL","enrollment":49},{"nctId":"NCT06647940","phase":"PHASE2","title":"Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）","status":"RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2024-11-01","conditions":"Diffuse Large B Cell Lymphoma (DLBCL)","enrollment":39},{"nctId":"NCT06290817","phase":"PHASE2","title":"Orelabrutinib Combined With R-CDOP for DLBCL Patients With High-risk of CNS Relapse Defined by CNS-IPI","status":"UNKNOWN","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2023-03-30","conditions":"Diffuse Large B-cell Lymphoma","enrollment":62},{"nctId":"NCT05234684","phase":"PHASE3","title":"A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With MCD Subtype Diffuse Large B-cell Lymphoma","status":"UNKNOWN","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","startDate":"2022-11-02","conditions":"Diffuse Large B Cell Lymphoma (DLBCL)","enrollment":150},{"nctId":"NCT06015464","phase":"","title":"An Ambispective Cohort Study of Orelabrutinib in Combination With Standard Treatment Regimen for Untreated DLBCL","status":"UNKNOWN","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2023-09-01","conditions":"Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type","enrollment":81},{"nctId":"NCT05933967","phase":"PHASE2","title":"A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma","status":"RECRUITING","sponsor":"Shandong Cancer Hospital and Institute","startDate":"2023-06-01","conditions":"The First Affiliated Hospital of Nanchang University","enrollment":31},{"nctId":"NCT05351346","phase":"PHASE3","title":"Genotype-guided Treatment in DLBCL","status":"RECRUITING","sponsor":"Ruijin Hospital","startDate":"2022-06-01","conditions":"Diffuse Large B Cell Lymphoma","enrollment":1100},{"nctId":"NCT05498259","phase":"PHASE2","title":"Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL","status":"UNKNOWN","sponsor":"The First Affiliated Hospital of Soochow University","startDate":"2022-07-27","conditions":"Diffuse Large B-Cell Lymphoma","enrollment":46},{"nctId":"NCT05051891","phase":"PHASE3","title":"A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma","status":"RECRUITING","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","startDate":"2021-12-22","conditions":"Treatment-naїve Mantle Cell Lymphoma","enrollment":356},{"nctId":"NCT05097443","phase":"PHASE3","title":"Orelabrutinib, Rituximab and Combination Chemotherapy in Newly-diagnosed Aggressive B-cell Non-Hodgkin Lymphoma","status":"UNKNOWN","sponsor":"Shandong Provincial Hospital","startDate":"2021-04-15","conditions":"High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements, High Grade B-Cell Lymphoma, Not Otherwise Specified, Diffuse Large B-cell Lymphoma","enrollment":130}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ICP-022+ R-CHOP"],"phase":"phase_3","status":"active","brandName":"Orelabrutinib + R-CHOP","genericName":"Orelabrutinib + R-CHOP","companyName":"Beijing InnoCare Pharma Tech Co., Ltd.","companyId":"beijing-innocare-pharma-tech-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Orelabrutinib is being studied in combination with a R-CHOP-like regimen for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL), among other conditions. This combination is being investigated in a Phase 2 study (NCT05498259) at The First Affiliated Hospital of Soochow University.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}