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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 5 years
- Procedures mentioned: Blood draws, CT scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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 undergo echocardiography or multigated acquisition (MUGA) scan and buccal swab collection during screening, as well as computed tomography (CT) scan and/or positron emission tomography (PET)/CT, and blood sample collection throughout the study."
- "Patients undergo echocardiography or MUGA scan and buccal swab collection during screening, as well as CT scan and/or PET, and blood sample collection throughout the study."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether adding pirtobrutinib to the usual treatment, called R-CHOP, works better than R-CHOP alone. It is for adults with newly diagnosed Richter transformation, when chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) changes into a faster-growing lymphoma.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older with Richter transformation confirmed by a tissue or cell test.
- Have cancer that can be measured, and have a PET/CT scan to check its spread within 42 days before joining.
- Be able to care for yourself and be up and about for at least half of your waking hours.
- Have a recent health exam and meet the study’s blood count, liver, kidney, and heart test limits.
- Be able to swallow and keep down pills, with no gut problems that would keep your body from absorbing them.
- If you have HIV or hepatitis B or C, meet the study’s treatment and virus-level rules.
- Agree to use effective birth control if you could become pregnant or cause a pregnancy.
- Agree to provide blood and lymph tissue samples for research.
Who can't join
- Past treatment with pirtobrutinib.
- Past treatment for Richter transformation, except limited steroid use. Some CLL/SLL treatments are allowed but must stop before study treatment.
- A health reason you cannot receive doxorubicin, a chemotherapy drug, or past doses above the study’s limits.
- Need for certain drugs called strong CYP3A inducers, unless you can switch drugs and stop them in time. These drugs affect how the body handles pirtobrutinib.
- Another cancer that could affect the study’s safety or results.
- Major surgery within 28 days before joining.
- Major bleeding or a severe abnormal heartbeat during past treatment with a BTK inhibitor, a type of cancer drug.
- Being pregnant or feeding breast milk to a baby.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Participants must have been diagnosed with Richter Transformation (RT) (CLL/small lymphocytic lymphoma \[SLL\] to LBCL) * Participants must have histologically or cytologically confirmed LBCL * Participants must have measurable disease determined by PET/CT or hematopathology (by morphology or flow cytometry) assessment within 42 days prior to registration * Participants must have staging PET/CT imaging performed within 42 days prior to registration * Participants are allowed prior treatments for CLL/SLL or its complications (autoimmune hemolytic anemia \[AIHA\], immune thrombocytopenic purpura \[ITP\]), with the exception of pirtobrutinib * 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/SLL with CLL/SLL 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 * Participants must not have contraindication for receiving anthracycline. Participants must not have received more than a cumulative dose of 100mg/m\^2 in those participants who will receive R-CHOP or not more than 250 mg/m\^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) * Patients requiring strong CYP3A inducers are not eligible and can only be enrolled if * an alternative treatment to the strong CYP3A inducer is available for them and * 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 * Participant must be ≥ 18 years old at the time of registration * Participant must have Eastern Cooperative Oncology Group (ECOG)/Zubrod Performance Status of 0-2 * Participant must have a complete medical history and physical exam within 28 days prior to registration * Absolute neutrophil count (ANC) ≥ 0.75 x 10\^3/µL or ≥ 0.50 x 10\^3/µL in participants with suspected marrow involvement considered to impair hematopoiesis (within 28 days prior to registration) * Platelets ≥ 50 x 10\^3/µL or ≥ 30 x 10\^3/µL in participants with suspected marrow involvement considered to impair hematopoiesis (within 28 days prior to registration) * Hemoglobin ≥ 8 g/dL (≥ 80 g/L) or ≥ 6 g/dL in participants with suspected bone marrow involvement considered to impair hematopoiesis (within 28 days prior to registration) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or ≤ 3 x ULN with documented liver involvement and/or Gilbert's disease (within 28 days prior to registration) * Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 3 × institutional ULN or ≤ 5 ULN with documented liver involvement (within 28 days prior to registration) * Participants must have a calculated creatinine clearance ≥ 30 mL/min 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://txwb.crab.org/TXWB/Tools.aspx * Participants must have a left ventricular ejection fraction (LVEF) ≥ 45% as measured by echocardiogram or radionuclide (MUGA) ventriculography within 56 days prior to registration * 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 * 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 * 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 * 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 * Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications * Participants must not have a prior or concurrent malignancy in addition to CLL/SLL 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 * Participants must not have had major surgery within 28 days prior to registration * Participants must not have experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor. * 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 * 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/occlusion, and vasectomy with testing showing no sperm in the semen * Participants must be offered the opportunity to participate in specimen banking * Participants must agree to have blood and lymphatic tissue specimens submitted for the integrated translational medicine study * 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
Study sites (62)
CA
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, CA 92612Site Public Contact · Study contact · 877-827-8839 · ucstudy@uci.eduCatherine C. Coombs · Principal investigatorMore trials in Irvine
- UCI Health Laguna Hills · Laguna Hills, CA 92653Site Public Contact · Study contact · 877-827-8839 · ucstudy@uci.eduCatherine C. Coombs · Principal investigatorMore trials in Laguna Hills
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, CA 92868Site Public Contact · Study contact · 877-827-8839 · ucstudy@uci.eduCatherine C. Coombs · Principal investigatorMore trials in Orange
IL
- Illinois CancerCare-Bloomington · Bloomington, IL 61704Site Public Contact · Study contact · 309-243-3605 · andersonj@illinoiscancercare.comBryan A. Faller · Principal investigatorMore trials in Bloomington
- Illinois CancerCare-Canton · Canton, IL 61520Site Public Contact · Study contact · 309-243-3605 · andersonj@illinoiscancercare.comBryan A. Faller · Principal investigatorMore trials in Canton
- Illinois CancerCare-Carthage · Carthage, IL 62321Site Public Contact · Study contact · 309-243-3605 · andersonj@illinoiscancercare.comBryan A. Faller · Principal investigatorMore trials in Carthage
- Carle at The Riverfront · Danville, IL 61832Site Public Contact · Study contact · 800-446-5532 · Research@Carle.comSuparna Mantha · Principal investigatorMore trials in Danville
- Cancer Care Specialists of Illinois - Decatur · Decatur, IL 62526Site Public Contact · Study contact · 217-876-4762 · morganthaler.jodi@mhsil.comBryan A. Faller · Principal investigatorMore trials in Decatur
- Decatur Memorial Hospital · Decatur, IL 62526Site Public Contact · Study contact · 217-876-4762 · morganthaler.jodi@mhsil.comBryan A. Faller · Principal investigatorMore trials in Decatur
- Carle Physician Group-Effingham · Effingham, IL 62401Site Public Contact · Study contact · 800-446-5532 · Research@carle.comSuparna Mantha · Principal investigatorMore trials in Effingham
- Illinois CancerCare-Eureka · Eureka, IL 61530Site Public Contact · Study contact · 309-243-3605 · andersonj@illinoiscancercare.comBryan A. Faller · Principal investigatorMore trials in Eureka
- Illinois CancerCare-Galesburg · Galesburg, IL 61401Site Public Contact · Study contact · 309-243-3605 · andersonj@illinoiscancercare.comBryan A. Faller · Principal investigatorMore trials in Galesburg
- Illinois CancerCare-Kewanee Clinic · Kewanee, IL 61443Site Public Contact · Study contact · 309-243-3605 · andersonj@illinoiscancercare.comBryan A. Faller · Principal investigatorMore trials in Kewanee
- Illinois CancerCare-Macomb · Macomb, IL 61455Site Public Contact · Study contact · 309-243-3605 · andersonj@illinoiscancercare.comBryan A. Faller · Principal investigatorMore trials in Macomb
- Carle Physician Group-Mattoon/Charleston · Mattoon, IL 61938Site Public Contact · Study contact · 800-446-5532 · Research@carle.comSuparna Mantha · Principal investigatorMore trials in Mattoon
- Carle BroMenn Medical Center · Normal, IL 61761Site Public Contact · Study contact · 800-446-5532 · Research@Carle.comSuparna Mantha · Principal investigatorMore trials in Normal
- Carle Cancer Institute Normal · Normal, IL 61761Site Public Contact · Study contact · 800-446-5532 · Research@Carle.comSuparna Mantha · Principal investigatorMore trials in Normal
- Cancer Care Center of O'Fallon · O'Fallon, IL 62269Site Public Contact · Study contact · 217-876-4762 · morganthaler.jodi@mhsil.comBryan A. Faller · Principal investigatorMore trials in O'Fallon
- HSHS Saint Elizabeth's Hospital · O'Fallon, IL 62269Site Public Contact · Study contact · 217-876-4762 · morganthaler.jodi@mhsil.comBryan A. Faller · Principal investigatorMore trials in O'Fallon
- Illinois CancerCare-Ottawa Clinic · Ottawa, IL 61350Site Public Contact · Study contact · 309-243-3605 · andersonj@illinoiscancercare.comBryan A. Faller · Principal investigatorMore trials in Ottawa
- Illinois CancerCare-Pekin · Pekin, IL 61554Site Public Contact · Study contact · 309-243-3605 · andersonj@illinoiscancercare.comBryan A. Faller · Principal investigatorMore trials in Pekin
- Illinois CancerCare-Peoria · Peoria, IL 61615Site Public Contact · Study contact · 309-243-3605 · andersonj@illinoiscancercare.comBryan A. Faller · Principal investigatorMore trials in Peoria
- Illinois CancerCare-Peru · Peru, IL 61354Site Public Contact · Study contact · 309-243-3605 · andersonj@illinoiscancercare.comBryan A. Faller · Principal investigatorMore trials in Peru
- Illinois CancerCare-Princeton · Princeton, IL 61356Site Public Contact · Study contact · 309-243-3605 · andersonj@illinoiscancercare.comBryan A. Faller · Principal investigatorMore trials in Princeton
- Memorial Hospital East · Shiloh, IL 62269Site Public Contact · Study contact · 314-747-9912 · dschwab@wustl.eduDilan A. Patel · Principal investigatorMore trials in Shiloh
- Southern Illinois University School of Medicine · Springfield, IL 62702Site Public Contact · Study contact · 217-545-7929Bryan A. Faller · Principal investigatorMore trials in Springfield
- Springfield Clinic · Springfield, IL 62702Site Public Contact · Study contact · 800-444-7541Bryan A. Faller · Principal investigatorMore trials in Springfield
- Springfield Memorial Hospital · Springfield, IL 62781Site Public Contact · Study contact · 217-528-7541 · pallante.beth@mhsil.comBryan A. Faller · Principal investigatorMore trials in Springfield
- Carle Cancer Center · Urbana, IL 61801Site Public Contact · Study contact · 800-446-5532 · Research@carle.comSuparna Mantha · Principal investigatorMore trials in Urbana
- Illinois CancerCare - Washington · Washington, IL 61571Site Public Contact · Study contact · 309-243-3605 · andersonj@illinoiscancercare.comBryan A. Faller · Principal investigatorMore trials in Washington
LA
- Our Lady of the Lake Physician Group · Baton Rouge, LA 70808Site Public Contact · Study contact · 225-765-7659 · research@ololrmc.comNakhle S. Saba · Principal investigatorMore trials in Baton Rouge
MI
- Trinity Health IHA Medical Group Hematology Oncology - Brighton · Brighton, MI 48114Site Public Contact · Study contact · 734-712-7251 · MCRCwebsitecontactform@stjoeshealth.orgTareq Al baghdadi · Principal investigatorMore trials in Brighton
- Trinity Health IHA Medical Group Hematology Oncology - Canton · Canton, MI 48188Site Public Contact · Study contact · 734-712-7251 · MCRCwebsitecontactform@stjoeshealth.orgTareq Al baghdadi · Principal investigatorMore trials in Canton
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital · Chelsea, MI 48118Site Public Contact · Study contact · 734-712-7251 · MCRCwebsitecontactform@stjoeshealth.orgTareq Al baghdadi · Principal investigatorMore trials in Chelsea
- Trinity Health Saint Mary Mercy Livonia Hospital · Livonia, MI 48154Site Public Contact · Study contact · 734-712-7251 · MCRCwebsitecontactform@stjoeshealth.orgTareq Al baghdadi · Principal investigatorMore trials in Livonia
- Trinity Health Saint Joseph Mercy Oakland Hospital · Pontiac, MI 48341Site Public Contact · Study contact · 734-712-7251 · MCRCwebsitecontactform@stjoeshealth.orgTareq Al baghdadi · Principal investigatorMore trials in Pontiac
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus · Ypsilanti, MI 48197Site Public Contact · Study contact · 734-712-7251 · MCRCwebsitecontactform@stjoeshealth.orgTareq Al baghdadi · Principal investigatorMore trials in Ypsilanti
MO
- Siteman Cancer Center at Saint Peters Hospital · City of Saint Peters, MO 63376Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduDilan A. Patel · Principal investigatorMore trials in City of Saint Peters
- Siteman Cancer Center at West County Hospital · Creve Coeur, MO 63141Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduDilan A. Patel · Principal investigatorMore trials in Creve Coeur
- Washington University School of Medicine · St Louis, MO 63110Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduDilan A. Patel · Principal investigatorMore trials in St Louis
- Siteman Cancer Center-South County · St Louis, MO 63129Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduDilan A. Patel · Principal investigatorMore trials in St Louis
- Siteman Cancer Center at Christian Hospital · St Louis, MO 63136Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduDilan A. Patel · Principal investigatorMore trials in St Louis
NC
- UNC Lineberger Comprehensive Cancer Center · Chapel Hill, NC 27599Site Public Contact · Study contact · 877-668-0683 · cancerclinicaltrials@med.unc.eduChristopher E. Jensen · Principal investigatorMore trials in Chapel Hill
- Duke University Medical Center · Durham, NC 27710Site Public Contact · Study contact · 888-275-3853Andrea Sitlinger · Principal investigatorMore trials in Durham
PA
- Thomas Jefferson University Hospital · Philadelphia, PA 19107Site Public Contact · Study contact · 215-600-9151 · ONCTrialNow@jefferson.eduMichael Wysota · Principal investigatorMore trials in Philadelphia
UT
- Huntsman Cancer Institute/University of Utah · Salt Lake City, UT 84112Site Public Contact · Study contact · 888-424-2100 · cancerinfo@hci.utah.eduBoyu Hu · Principal investigatorMore trials in Salt Lake City
VA
- VCU Massey Cancer Center at Stony Point · Richmond, VA 23235Site Public Contact · Study contact · ctoclinops@vcu.eduVictor Y. Yazbeck · Principal investigatorMore trials in Richmond
- VCU Massey Comprehensive Cancer Center · Richmond, VA 23298Site Public Contact · Study contact · 804-628-6430 · CTOclinops@vcu.eduVictor Y. Yazbeck · Principal investigatorMore trials in Richmond
WA
- FHCC Overlake · Bellevue, WA 98004Site Public Contact · Study contact · 425-454-2148Jason Comer · Principal investigatorMore trials in Bellevue
- FHCC at EvergreenHealth · Kirkland, WA 98034Site Public Contact · Study contact · 425-899-6000Vikram Raghunathan · Principal investigatorMore trials in Kirkland
- Fred Hutchinson Cancer Center · Seattle, WA 98109Site Public Contact · Study contact · 800-804-8824Mazyar Shadman · Principal investigatorMore trials in Seattle
- FHCC at Northwest Hospital · Seattle, WA 98133Site Public Contact · Study contact · 206-606-5800Paul S. Martin · Principal investigatorMore trials in Seattle
- University of Washington Medical Center - Montlake · Seattle, WA 98195Site Public Contact · Study contact · 800-804-8824Mazyar Shadman · Principal investigatorMore trials in Seattle
WI
- Froedtert Menomonee Falls Hospital · Menomonee Falls, WI 53051Site Public Contact · Study contact · 262-257-5100Gulrayz Ahmed · Principal investigatorMore trials in Menomonee Falls
- Medical College of Wisconsin · Milwaukee, WI 53226Site Public Contact · Study contact · 414-805-3666Gulrayz Ahmed · Principal investigatorMore trials in Milwaukee
- ProHealth D N Greenwald Center · Mukwonago, WI 53149Site Public Contact · Study contact · research.institute@phci.orgTimothy R. Wassenaar · Principal investigatorMore trials in Mukwonago
- Froedtert and MCW Moorland Reserve Health Center · New Berlin, WI 53151Site Public Contact · Study contact · 414-805-0505Gulrayz Ahmed · Principal investigatorMore trials in New Berlin
- Drexel Town Square Health Center · Oak Creek, WI 53154Site Public Contact · Study contact · 414-805-0505Gulrayz Ahmed · Principal investigatorMore trials in Oak Creek
- ProHealth Oconomowoc Memorial Hospital · Oconomowoc, WI 53066Site Public Contact · Study contact · 262-928-7878Timothy R. Wassenaar · Principal investigatorMore trials in Oconomowoc
- ProHealth Waukesha Memorial Hospital · Waukesha, WI 53188Site Public Contact · Study contact · 262-928-7632Timothy R. Wassenaar · Principal investigatorMore trials in Waukesha
- UW Cancer Center at ProHealth Care · Waukesha, WI 53188Site Public Contact · Study contact · 262-928-5539 · Chanda.miller@phci.orgTimothy R. Wassenaar · Principal investigatorMore trials in Waukesha
- Froedtert West Bend Hospital/Kraemer Cancer Center · West Bend, WI 53095Site Public Contact · Study contact · 414-805-0505Gulrayz Ahmed · Principal investigatorMore trials in West Bend