[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609869":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":316,"centralContacts":307,"locations":307,"responsibleParty":320,"collaborators":322,"id":326,"slug":327,"hasResults":328,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":307,"eligibilityCriteria":332,"healthyVolunteers":328,"sex":333,"minAge":334,"maxAge":307,"enrollmentInfo":335,"targetDuration":307,"studyType":338,"phases":339,"briefSummary":341,"conditions":342,"keywords":307,"overallStatus":346,"whyStopped":307,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":307},{"fullName":5,"class":6},"SWOG Cancer Research Network","NETWORK",[8,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm I (pirtobrutinib and R-CHOP)","EXPERIMENTAL","Patients receive pirtobrutinib PO QD on days 1-21 of each cycle, rituximab IV or rituximab hyaluronidase SC (starting with cycle 2), cyclophosphamide IV on day 1 of each cycle, doxorubicin IV on day 1 of each cycle, vincristine IV on day 1 of each cycle, and prednisone PO QD on days 1-5 of each cycle. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients continue to receive pirtobrutinib PO QD on days 1-21 of each cycle for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients with progressive disease or symptomatic deterioration may receive 1 additional cycle as long as the participant is continuing to clinically benefit from treatment in the opinion of the treating investigator. Patients undergo echocardiography or MUGA scan and buccal swab collection during screening, as well as CT scan and\u002For PET\u002FCT, and blood sample collection throughout the study.",[13,14,15,16,17,18,19,20,21,22,23,24,25],"Procedure: Biospecimen Collection","Procedure: Computed Tomography","Drug: Cyclophosphamide","Drug: Doxorubicin Hydrochloride","Procedure: Echocardiography Test","Procedure: Multigated Acquisition Scan","Drug: Pirtobrutinib","Procedure: Positron Emission Tomography","Drug: Prednisone","Biological: Rituximab","Biological: Rituximab and Hyaluronidase Human","Other: Survey Administration","Drug: Vincristine",{"label":27,"type":28,"description":29,"interventionNames":30},"Arm II (R-CHOP)","ACTIVE_COMPARATOR","Patients receive rituximab IV or rituximab hyaluronidase SC (starting with cycle 2), cyclophosphamide IV on day 1 of each cycle, doxorubicin IV on day 1 of each cycle, vincristine IV on day 1 of each cycle, and prednisone PO QD on days 1-5 of each cycle. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or MUGA scan and buccal swab collection during screening, as well as CT scan and\u002For PET, and blood sample collection throughout the study.",[13,14,15,16,17,18,20,21,22,23,24,25],[32,41,58,105,134,141,159,171,183,229,293,302,308],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"PROCEDURE","Biospecimen Collection","Undergo blood and buccal swab sample collection",[9,27],[38,39,40],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":33,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Computed Tomography","Undergo CT scan and\u002For PET\u002FCT scan",[9,27],[46,47,48,49,50,51,52,53,54,55,56,57],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography",{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"DRUG","Cyclophosphamide","Given IV",[9,27],[64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104],"(-)-Cyclophosphamide","2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate","Asta B 518","B 518","B-518","B518","Carloxan","Ciclofosfamida","Ciclofosfamide","Cicloxal","Clafen","Claphene","CP monohydrate","CTX","CYCLO-cell","Cycloblastin","Cycloblastine","Cyclophospham","Cyclophosphamid monohydrate","Cyclophosphamide Monohydrate","Cyclophosphamidum","Cyclophosphan","Cyclophosphane","Cyclophosphanum","Cyclostin","Cyclostine","Cytophosphan","Cytophosphane","Cytoxan","Fosfaseron","Genoxal","Genuxal","Ledoxina","Mitoxan","Neosar","Revimmune","Syklofosfamid","WR 138719","WR- 138719","WR-138719","WR138719",{"type":59,"name":106,"description":61,"armGroupLabels":107,"otherNames":108},"Doxorubicin Hydrochloride",[9,27],[109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133],"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":33,"name":135,"description":136,"armGroupLabels":137,"otherNames":138},"Echocardiography Test","Undergo echocardiography",[9,27],[139,140],"EC","Echocardiography",{"type":33,"name":142,"description":143,"armGroupLabels":144,"otherNames":145},"Multigated Acquisition Scan","Undergo MUGA scan",[9,27],[146,147,148,149,150,151,152,153,154,155,156,157,158],"Blood Pool Scan","Equilibrium Radionuclide Angiography","Gated Blood Pool Imaging","Gated Heart Pool Scan","MUGA","MUGA Scan","Multi-Gated Acquisition Scan","Radionuclide Ventriculogram Scan","Radionuclide Ventriculography","RNV Scan","RNVG","SYMA Scanning","Synchronized Multigated Acquisition Scanning",{"type":59,"name":160,"description":161,"armGroupLabels":162,"otherNames":163},"Pirtobrutinib","Given PO",[9],[164,165,166,167,168,169,170],"5-Amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-((2S)-1,1,1-trifluoropropan-2-yl)-1h-pyrazole-4-carboxamide","BTK Inhibitor LOXO-305","Jaypirca","LOXO 305","LOXO-305","LOXO305","LY3527727",{"type":33,"name":172,"description":173,"armGroupLabels":174,"otherNames":175},"Positron Emission Tomography","Undergo PET\u002FCT scan",[9,27],[176,177,178,179,180,181,182],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":59,"name":184,"description":161,"armGroupLabels":185,"otherNames":186},"Prednisone",[9,27],[187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228],".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":230,"name":231,"description":61,"armGroupLabels":232,"otherNames":233},"BIOLOGICAL","Rituximab",[9,27],[234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292],"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":230,"name":294,"description":295,"armGroupLabels":296,"otherNames":297},"Rituximab and Hyaluronidase Human","Given SC",[9,27],[298,299,300,301],"Rituxan Hycela","Rituximab Plus Hyaluronidase","Rituximab\u002FHyaluronidase","Rituximab\u002FHyaluronidase Human",{"type":303,"name":304,"description":305,"armGroupLabels":306,"otherNames":307},"OTHER","Survey Administration","Ancillary studies",[9,27],null,{"type":59,"name":309,"description":61,"armGroupLabels":310,"otherNames":311},"Vincristine",[9,27],[312,313,314,315],"LCR","Leurocristine","VCR","Vincrystine",[317],{"name":318,"affiliation":5,"role":319},"Mazyar Shadman","PRINCIPAL_INVESTIGATOR",{"type":321,"investigatorFullName":307,"investigatorTitle":307,"investigatorAffiliation":307,"oldNameTitle":307,"oldOrganization":307},"SPONSOR",[323],{"name":324,"class":325},"National Cancer Institute (NCI)","NIH","100609869","phase-3-adding-pirtobrutinib-to-the-usual-treatment-for-people-with-newly-diagnosed-richter-transformation-the-piramid-trial-100609869",false,"NCT07220187","Adding Pirtobrutinib to the Usual Treatment for People With Newly Diagnosed Richter Transformation, The PIRAMID Trial","A Randomized Phase III Study of Pirtobrutinib Plus R-CHOP vs. R-CHOP for Participants With Previously Untreated Richter Transformation (PIRAMID)","Inclusion Criteria:\n\n* Participants must have been diagnosed with Richter Transformation (RT) (CLL\u002Fsmall lymphocytic lymphoma \\[SLL\\] to LBCL)\n\n  * Participants must have histologically or cytologically confirmed LBCL\n* Participants must have measurable disease determined by PET\u002FCT or hematopathology (by morphology or flow cytometry) assessment within 42 days prior to registration\n* Participants must have staging PET\u002FCT imaging performed within 42 days prior to registration\n* Participants are allowed prior treatments for CLL\u002FSLL or its complications (autoimmune hemolytic anemia \\[AIHA\\], immune thrombocytopenic purpura \\[ITP\\]), with the exception of pirtobrutinib\n* Participants must not have prior treatment for Richter transformation except for corticosteroids up to equivalent dose of prednisone 700 mg total for less than 7 days for disease control. Treatment for CLL\u002FSLL with CLL\u002FSLL directed drugs (including BTK inhibitors with the exception of pirtobrutinib) after the Richter transformation diagnosis is allowed for the purpose of disease control. CLL targeted therapies must be stopped within 3 days before initiation of therapy on protocol. Chemotherapy or anti-CD20 monoclonal antibody therapy must be stopped within 2 weeks before initiation of therapy on protocol\n* Participants must not have contraindication for receiving anthracycline. Participants must not have received more than a cumulative dose of 100mg\u002Fm\\^2 in those participants who will receive R-CHOP or not more than 250 mg\u002Fm\\^2 in those participants who will receive R-mini-CHOP of prior doxorubicin (or equivalent dose of another anthracycline, such as epirubicin) therapy (at any time prior to registration)\n* Patients requiring strong CYP3A inducers are not eligible and can only be enrolled if\n\n  * an alternative treatment to the strong CYP3A inducer is available for them and\n  * the last dose of the strong CYP3A inducer is administered at least 7 days before initiation of pirtobrutinib for patients in safety run-in and arm 1\n* Participant must be ≥ 18 years old at the time of registration\n* Participant must have Eastern Cooperative Oncology Group (ECOG)\u002FZubrod Performance Status of 0-2\n* Participant must have a complete medical history and physical exam within 28 days prior to registration\n* Absolute neutrophil count (ANC) ≥ 0.75 x 10\\^3\u002FµL or ≥ 0.50 x 10\\^3\u002FµL in participants with suspected marrow involvement considered to impair hematopoiesis (within 28 days prior to registration)\n* Platelets ≥ 50 x 10\\^3\u002FµL or ≥ 30 x 10\\^3\u002FµL in participants with suspected marrow involvement considered to impair hematopoiesis (within 28 days prior to registration)\n* Hemoglobin ≥ 8 g\u002FdL (≥ 80 g\u002FL) or ≥ 6 g\u002FdL in participants with suspected bone marrow involvement considered to impair hematopoiesis (within 28 days prior to registration)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or ≤ 3 x ULN with documented liver involvement and\u002For Gilbert's disease (within 28 days prior to registration)\n* Aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) ≤ 3 × institutional ULN or ≤ 5 ULN with documented liver involvement (within 28 days prior to registration)\n* Participants must have a calculated creatinine clearance ≥ 30 mL\u002Fmin using the Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration. For the Cockcroft-Gault formula for calculated creatinine clearance, see the tools on the CRA Workbench https:\u002F\u002Ftxwb.crab.org\u002FTXWB\u002FTools.aspx\n* Participants must have a left ventricular ejection fraction (LVEF) ≥ 45% as measured by echocardiogram or radionuclide (MUGA) ventriculography within 56 days prior to registration\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Participants' HIV-directed therapy cannot have known interactions with pirtobrutinib\n* Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration\n* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration\n* Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications\n* Participants must not have a prior or concurrent malignancy in addition to CLL\u002FSLL and Richter transformation whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not have had major surgery within 28 days prior to registration\n* Participants must not have experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor.\n\n  * NOTE: Major bleeding is defined as bleeding having one or more of the following features: potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in the hemoglobin level of at least 2g per deciliter; or bleeding in a critical area or organ (e.g., retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants must agree to have blood and lymphatic tissue specimens submitted for the integrated translational medicine study\n* For randomized participants only: Participants who can complete PRO-CTCAE and FACIT GP5 questionnaires forms in English or Spanish must be offered the opportunity to participate in the patient-reported outcome","ALL","18 Years",{"count":336,"type":337},102,"ESTIMATED","INTERVENTIONAL",[340],"PHASE3","This phase III trial compares the effect of adding pirtobrutinib to the usual treatment with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) to R-CHOP alone for the treatment of Richter transformation, which is when chronic lymphocytic leukemia or small lymphocytic lymphoma turns into large B-cell lymphoma, a more aggressive (faster-growing) form of lymphoma. Pirtobrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Adding pirtobrutinib to R-CHOP may kill more cancer cells than R-CHOP alone in patients with Richter transformation.",[343,344,345],"Richter Syndrome","Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma","Transformed Small Lymphocytic Lymphoma to Diffuse Large B-Cell Lymphoma","NOT_YET_RECRUITING","2026-06-09",{"date":349,"type":350},"2026-06-11","ACTUAL",{"date":352,"type":337},"2026-08-31",{"date":354,"type":337},"2036-10",{"name":5,"class":6}]