{"preliminary_commentary":{"by_channel":{"youtube":4,"podcast":3,"x_thread":2},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04115631\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"name":"EA4181","nct_id":"NCT04115631","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ea4181-nct04115631. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive bendamustine IV on days 1 and 2 and rituximab IV on day 1 or 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 4, patients receive rituximab IV on day 1 and cytarabine IV every Q12 hours on days 1 and 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.","label":"Arm A (bendamustine, rituximab, cytarabine)","type":"EXPERIMENTAL"},{"description":"Patients receive PO BID on days 1-28, bendamustine IV on days 1 and 2, and rituximab IV on day 1 or 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 4, patients receive acalabrutinib PO BID on days 1-7 and 22-28, rituximab IV on day 1, and cytarabine IV Q12 hours on days 1 and 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.","label":"Arm B (acalabrutinib, bendamustine, rituximab, cytarabine)","type":"EXPERIMENTAL"},{"description":"Patients receive acalabrutinib PO BID on days 1-28, bendamustine IV on days 1 and 2, and rituximab IV on day 1 or 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.","label":"Arm C (acalabrutinib, bendamustine, rituximab)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2026-12-31","type":"ESTIMATED"},"conditions":["Liver Lymphoma","Mantle Cell Lymphoma"],"enrollment":{"count":360,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Acalabrutinib","otherNames":["ACP-196","Bruton Tyrosine Kinase Inhibitor ACP-196","Calquence"],"type":"DRUG"},{"name":"Bendamustine","otherNames":["SDX-105"],"type":"DRUG"},{"name":"Bendamustine Hydrochloride","otherNames":["Bendamustin Hydrochloride","Bendeka","Cytostasan Hydrochloride","Levact","Ribomustin","SyB L-0501","Treanda"],"type":"DRUG"},{"name":"Cytarabine","otherNames":[".beta.-Cytosine arabinoside","1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone","1-.beta.-D-Arabinofuranosylcytosine","1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone","1-Beta-D-arabinofuranosylcytosine","1.beta.-D-Arabinofuranosylcytosine","2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-","2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-","Alexan","Ara-C","ARA-cell","Arabine","Arabinofuranosylcytosine","Arabinosylcytosine","Aracytidine","Aracytin","Aracytine","Beta-cytosine Arabinoside","CHX-3311","Cytarabinum","Cytarbel","Cytosar","Cytosine Arabinoside","Cytosine-.beta.-arabinoside","Cytosine-beta-arabinoside","Erpalfa","Starasid","Tarabine PFS","U 19920","U-19920","Udicil","WR-28453"],"type":"DRUG"},{"name":"Rituximab","otherNames":["ABP 798","BI 695500","C2B8 Monoclonal Antibody","Chimeric Anti-CD20 Antibody","CT-P10","IDEC-102","IDEC-C2B8","IDEC-C2B8 Monoclonal Antibody","MabThera","Monoclonal Antibody IDEC-C2B8","PF-05280586","Rituxan","Rituximab ABBS","Rituximab Biosimilar ABP 798","Rituximab Biosimilar BI 695500","Rituximab Biosimilar CT-P10","Rituximab Biosimilar GB241","Rituximab Biosimilar IBI301","Rituximab Biosimilar JHL1101","Rituximab Biosimilar PF-05280586","Rituximab Biosimilar RTXM83","Rituximab Biosimilar SAIT101","rituximab biosimilar TQB2303","rituximab-abbs","RTXM83","Truxima"],"type":"BIOLOGICAL"}],"last_update":"2026-09-14","lead_sponsor":"ECOG-ACRIN Cancer Research Group","official_title":"A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR-A), and 3.) Bendamustine, Rituximab and Acalabrutinib (BR-A) in Patients &lt;/= 70 Years Old With Untreated Mantle Cell Lymphoma","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2026-12-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Composite of positron emission tomography (PET)/computed tomography (CT) complete response (CR) and peripheral blood (PB) minimal residual disease (MRD) negative rate","timeFrame":"Up to 8 weeks post treatment"}],"references":[{"citation":"Patel DA, Wan F, Trinkaus K, Guy DG, Edwin N, Watkins M, Bartlett NL, Cashen A, Fehniger TA, Ghobadi A, Shah NM, Kahl BS. Bendamustine/Rituximab Plus Cytarabine/Rituximab, With or Without Acalabrutinib, for the Initial Treatment of Transplant-Eligible Mantle Cell Lymphoma Patients: Pooled Data From Two Pilot Studies. Clin Lymphoma Myeloma Leuk. 2023 Jul;23(7):552-560. doi: 10.1016/j.clml.2023.04.003. Epub 2023 Apr 24.","pmid":"37183115","type":"DERIVED"}],"start_date":{"date":"2019-12-13","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma","url":"https://clinicaltrials.gov/study/NCT04115631"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/ea4181-nct04115631"}