{"preliminary_commentary":{"by_channel":{"x_thread":4},"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":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"NCT03984448","nct_id":"NCT03984448","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03984448. 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":"DEL: Patients with DEL receive R-CHOP chemotherapy regimen consisting of rituximab IV on day 1, cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO QD on days 1-5. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET scan, CT scan and blood sample collection and may undergo bone marrow biopsy and lumbar puncture throughout the study.\n\nDHL: Patients with DHL receive DA-EPOCH-R chemotherapy regimen consisting of rituximab IV on day 1, doxorubicin hydrochloride IV on days 1-4, etoposide IV on days 1-4, vincristine sulfate IV on days 1-4, prednisone PO BID on days 1-5, and cyclophosphamide IV on day 5. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET scan, CT scan and blood sample collection and may undergo bone marrow biopsy and lumbar puncture throughout the study","label":"Arm 1 (R-CHOP, DA-EPOCH-R)","type":"ACTIVE_COMPARATOR"},{"description":"DEL: Patients with DEL receive R-CHOP chemotherapy regimen as in Arm 1. Patients also receive venetoclax PO QD on days 4-8 of cycle 1 and days 1-5 for cycles 2-6. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET scan, CT scan and blood sample collection and may undergo bone marrow biopsy and lumbar puncture throughout the study.\n\nDHL: Patients with DHL receive DA-EPOCH-R chemotherapy regimen as in Arm 1. Patients also receive venetoclax PO QD on days 4-8 of cycle 1 and days 1-5 for cycles 2-6. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET scan, CT scan and blood sample collection and may undergo bone marrow biopsy and lumbar puncture throughout the study.","label":"Arm 2 (R-CHOP, DA-EPOCH-R, venetoclax)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2028-08-13","type":"ESTIMATED"},"conditions":["Diffuse Large B-Cell Lymphoma","Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Double-Expressor Lymphoma","EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","High Grade B-Cell Lymphoma, Not Otherwise Specified","Neoplastic Cells With Double Expression of MYC and BCL2 Proteins Present","Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma"],"enrollment":{"count":363,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Biospecimen Collection","otherNames":["Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen 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Monohydrate","Cyclophosphamidum","Cyclophosphan","Cyclophosphane","Cyclophosphanum","Cyclostin","Cyclostine","Cytophosphan","Cytophosphane","Cytoxan","Fosfaseron","Frindovyx","Genoxal","Genuxal","Ledoxina","Mitoxan","Neosar","Revimmune","Syklofosfamid","WR 138719","WR- 138719","WR-138719","WR138719"],"type":"DRUG"},{"name":"Doxorubicin Hydrochloride","otherNames":["5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)","ADM","Adriacin","Adriamycin","Adriamycin Hydrochloride","Adriamycin PFS","Adriamycin RDF","ADRIAMYCIN, HYDROCHLORIDE","Adriamycine","Adriblastina","Adriblastine","Adrimedac","Chloridrato de Doxorrubicina","DOX","DOXO-CELL","Doxolem","Doxorubicin HCl","Doxorubicin.HCl","Doxorubin","Farmiblastina","FI 106","FI-106","FI106","hydroxydaunorubicin","Rubex"],"type":"DRUG"},{"name":"Etoposide","otherNames":["Demethyl Epipodophyllotoxin Ethylidine Glucoside","EPEG","Lastet","Toposar","Vepesid","VP 16","VP 16-213","VP 16213","VP-16","VP-16-213","VP-16213","VP16","VP16213"],"type":"DRUG"},{"name":"Lumbar Puncture","otherNames":["LP","Spinal Tap"],"type":"PROCEDURE"},{"name":"Positron Emission Tomography","otherNames":["Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT"],"type":"PROCEDURE"},{"name":"Prednisone","otherNames":[".delta.1-Cortisone","1, 2-Dehydrocortisone","Adasone","Cortancyl","Dacortin","DeCortin","Decortisyl","Decorton","Delta 1-Cortisone","Delta-Dome","Deltacortene","Deltacortisone","Deltadehydrocortisone","Deltasone","Deltison","Deltra","Econosone","Lisacort","Meprosona-F","Metacortandracin","Meticorten","Ofisolona","Orasone","Panafcort","Panasol-S","Paracort","Perrigo Prednisone","PRED","Predicor","Predicorten","Prednicen-M","Prednicort","Prednidib","Prednilonga","Predniment","Prednisone Intensol","Prednisonum","Prednitone","Promifen","Rayos","Servisone","SK-Prednisone"],"type":"DRUG"},{"name":"Rituximab","otherNames":["ABP 798","ABP-798","ABP798","BI 695500","BI-695500","BI695500","Blitzima","C2B8 Monoclonal Antibody","Chimeric Anti-CD20 Antibody","CT P10","CT-P10","CTP10","GP 2013","GP-2013","GP2013","IDEC 102","IDEC-102","IDEC-C2B8","IDEC-C2B8 Monoclonal Antibody","IDEC102","Ikgdar","Mabtas","MabThera","Monoclonal Antibody IDEC-C2B8","PF 05280586","PF-05280586","PF05280586","Riabni","Ritemvia","Rituxan","Rituximab ABBS","Rituximab ARRX","Rituximab Biosimilar ABP 798","Rituximab Biosimilar BI 695500","Rituximab Biosimilar CT-P10","Rituximab Biosimilar GB241","Rituximab Biosimilar GP2013","Rituximab Biosimilar IBI301","Rituximab Biosimilar JHL1101","Rituximab Biosimilar PF-05280586","Rituximab Biosimilar RTXM83","Rituximab Biosimilar SAIT101","Rituximab Biosimilar SIBP-02","rituximab biosimilar TQB2303","Rituximab PVVR","Rituximab-abbs","Rituximab-arrx","Rituximab-blit","Rituximab-pvvr","Rituximab-rite","Rituximab-rixa","Rituximab-rixi","Rixathon","Riximyo","RTXM 83","RTXM-83","RTXM83","Ruxience","Truxima"],"type":"BIOLOGICAL"},{"name":"Venetoclax","otherNames":["ABT 199","ABT-0199","ABT-199","ABT199","GDC 0199","GDC-0199","GDC0199","RG7601","Venclexta","Venclyxto"],"type":"DRUG"},{"name":"Vincristine Sulfate","otherNames":["Kyocristine","Leurocristine Sulfate","Leurocristine, sulfate","Oncovin","Vincasar","Vincosid","Vincrex","Vincristine, sulfate"],"type":"DRUG"}],"last_update":"2026-10-26","lead_sponsor":"National Cancer Institute (NCI)","official_title":"Randomized Phase II/III Study of Venetoclax (ABT199) Plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double Expressing Lymphomas","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2028-08-13","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Progression-free survival (PFS) (phase II)","timeFrame":"From randomization date until the earlier of disease progression, or death from any cause, assessed up to 10 years"},{"measure":"PFS (phase III)","timeFrame":"At 24 months"}],"references":[{"citation":"Abramson JS, Geyer S, Giri S, Pederson L, Hudson A, Hsi ED, Mehta-Shah N, Reagan PM, Deming RL, Little RF, Gore S, Dinner SN, Vallurupalli A, Landsburg DJ, Kahl B, Friedberg JW, Bartlett NL, Leonard JP. Venetoclax added to dose-adjusted EPOCH-R for newly diagnosed double-hit lymphomas: phase 2 results from ALLIANCE A051701, an open-label, randomised, controlled, phase 2-3 trial. Lancet Haematol. 2026 Sep;13(9):e626-e638. doi: 10.1016/S2352-3026(26)00191-2.","pmid":"42660130","type":"DERIVED"},{"citation":"Rutherford SC, Abramson JS, Bartlett NL, Barta SK, Khan N, Joyce R, Maddocks K, Ali-Shaw T, Senese S, Yuan Y, Westin J, Leonard JP. Venetoclax with dose-adjusted EPOCH-R as initial therapy for patients with aggressive B-cell lymphoma: a single-arm, multicentre, phase 1 study. Lancet Haematol. 2021 Nov;8(11):e818-e827. doi: 10.1016/S2352-3026(21)00273-8. Epub 2021 Oct 8.","pmid":"34634256","type":"DERIVED"}],"start_date":{"date":"2019-10-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas","url":"https://clinicaltrials.gov/study/NCT03984448"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03984448"}