Non Hodgkin Lymphoma Clinical Trial

A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Summary

The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor
Platelets greater than or equal to (≥)50 x 10⁹/liter (L), hemoglobin ≥8 grams/deciliter (g/dL) and absolute neutrophil count ≥1.0 x 10⁹/L
Adequate organ function
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Estimated creatinine clearance ≥30 milliliters per minute (mL/min)

Exclusion Criteria:

Known or suspected Richter's transformation at any time preceding enrollment
Prior therapy with a non-covalent (reversible) BTK inhibitor
Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers
Prior therapy with venetoclax
Central nervous system (CNS) involvement
Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days
Active hepatitis B or hepatitis C
Known active cytomegalovirus (CMV) infection
Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)
Significant cardiovascular disease
Vaccination with a live vaccine within 28 days prior to randomization

Patients with the following hypersensitivity:

Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax
Prior significant hypersensitivity to rituximab
Known allergy to allopurinol and inability to take uric acid lowering agent

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

600

Study ID:

NCT04965493

Recruitment Status:

Recruiting

Sponsor:

Loxo Oncology, Inc.

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There are 137 Locations for this study

See Locations Near You

Mayo Clinic Hospital
Phoenix Arizona, 85054, United States More Info
Contact
480-342-5785
Jose Leis
Principal Investigator
The University of Arizona Cancer Center
Tucson Arizona, 85724, United States More Info
Contact
520-626-2548
A Kumar
Principal Investigator
University of California Irvine Medical Center
Orange California, 92868, United States More Info
Contact
714-509-2923
Susan O'Brien
Principal Investigator
Scripps Mercy Hospital
San Diego California, 92103, United States More Info
Contact
858-554-9253
Marin Xavier
Principal Investigator
Providence Medical Foundation
Santa Rosa California, 95403, United States More Info
Contact
707-521-3803
Jarrod Holmes
Principal Investigator
Stamford Hospital
Stamford Connecticut, 06904, United States More Info
Contact
203-276-7880
Kwok Ming Lo
Principal Investigator
Florida Cancer Specialists
Fort Myers Florida, 33916, United States More Info
Contact
239-274-9930
Liliana Bustamante
Principal Investigator
Cancer Specialists of North Florida -St Augustine
Jacksonville Florida, 32256, United States More Info
Contact
904-538-4488
Ayed Ayed
Principal Investigator
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States More Info
Contact
727-216-1143
Gustavo Fonseca
Principal Investigator
Florida Cancer Specialists
Tallahassee Florida, 32308, United States More Info
Contact
850-877-8166
Viralkumar Bhanderi
Principal Investigator
Florida Cancer Specialists East
West Palm Beach Florida, 33401, United States More Info
Contact
561-472-1696
Shachar Peles
Principal Investigator
Carle Cancer Center
Urbana Illinois, 61801, United States More Info
Contact
217-383-4085
Vamsi Vasireddy
Principal Investigator
Pikeville Medical Center, Inc.
Pikeville Kentucky, 41501, United States More Info
Contact
606-218-4682
Christopher Croot
Principal Investigator
Hematology Oncology Clinic
Baton Rouge Louisiana, 70809, United States More Info
Contact
225-761-3951
Michael Castine
Principal Investigator
American Oncology Partners of Maryland, PA
Bethesda Maryland, 20817, United States More Info
Contact
301-571-2016
Bruce Cheson
Principal Investigator
Mayo Clinic
Rochester Minnesota, 55905, United States More Info
Contact
507-538-3227
Yucai Wang
Principal Investigator
Central Care Cancer Center
Bolivar Missouri, 65613, United States More Info
Contact
417-326-7200
Leonid Shunyakov
Principal Investigator
Research Medical Center
Kansas City Missouri, 63142, United States More Info
Contact
816-276-4227
Suman Kambhampati
Principal Investigator
Memorial Sloan Kettering Cancer Center
Basking Ridge New Jersey, 07920, United States More Info
Contact
908-542-3193
Anthony Mato
Principal Investigator
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States More Info
Contact
551-996-5900
Lori Ann Leslie
Principal Investigator
Memorial Sloan Kettering Cancer Center
Middletown New Jersey, 07748, United States More Info
Contact
848-225-6443
Anthony Mato
Principal Investigator
Memorial Sloan Kettering Cancer Center
Montvale New Jersey, 07645, United States More Info
Contact
203-231-1674
Anthony Mato
Principal Investigator
Morristown Medical Center
Morristown New Jersey, 07962, United States More Info
Contact
973-971-5569
Charles Farber
Principal Investigator
Memorial Sloan Kettering Cancer Center
Commack New York, 11725, United States More Info
Contact
631-623-4100
Anthony Mato
Principal Investigator
Memorial Sloan Kettering Cancer Center
Harrison New York, 10604, United States More Info
Contact
914-367-7015
Anthony Mato
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States More Info
Contact
212-639-8596
Anthony Mato
Principal Investigator
Columbia University Medical Center
New York New York, 10032, United States More Info
Contact
212-305-2696
Nicole Lamanna
Principal Investigator
New York Medical College
New York New York, 10532, United States More Info
Contact
914-493-8375
Delong Liu
Principal Investigator
Memorial Sloan Kettering Cancer Center
Uniondale New York, 11553, United States More Info
Contact
212-639-8596
Anthony Mato
Principal Investigator
Levine Cancer Institute
Charlotte North Carolina, 28204, United States More Info
Contact
980-442-2315
Ryan Jacobs
Principal Investigator
Novant Cancer Institute Charlotte
Charlotte North Carolina, 28204, United States More Info
Contact
980-302-6360
Alan Skarbnik
Principal Investigator
Duke University Medical Center
Durham North Carolina, 27705, United States More Info
Contact
919-681-6580
Andrea Sitlinger
Principal Investigator
The James Cancer Hospital
Columbus Ohio, 43210, United States More Info
Contact
614-366-5643
Jennifer Woyach
Principal Investigator
Sarah Cannon Research Institute SCRI
Chattanooga Tennessee, 37404, United States More Info
Contact
423-622-6212
Bertrand Anz III
Principal Investigator
Tennessee Oncology PLLC
Nashville Tennessee, 37203, United States More Info
Contact
615-341-7810
Ian Flinn
Principal Investigator
Houston Methodist Cancer Center
Houston Texas, 77030, United States More Info
Contact
713-441-9948
Shilpan Shah
Principal Investigator
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Contact
713-563-5721
Philip Thompson
Principal Investigator
The Richland Hospital
Waukesha Wisconsin, 53188, United States More Info
Contact
262-696-5690
Timothy Wassenaar
Principal Investigator
Border Medical Oncology
Albury New South Wales, 2640, Australia More Info
Contact
61260641500
Anish Puliyayil
Principal Investigator
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia More Info
Contact
+61882226148
Uwe Hahn
Principal Investigator
Flinders Medical Centre
Adelaide South Australia, 5042, Australia More Info
Contact
61882045453
Bryone Kuss
Principal Investigator
Royal Hobart Hospital
Hobart Tasmania, 7000, Australia More Info
Contact
613616667886
Anna Johnston
Principal Investigator
St. Vincent's Hospital
Fitzroy Victoria, 3065, Australia More Info
Contact
92311141
Masa Lasica
Principal Investigator
Peninsula Private Hospital
Frankston Victoria, 3199, Australia More Info
Contact
61397880993
Patricia Walker
Principal Investigator
Fiona Stanley Hospital
Murdoch Western Australia, 6150, Australia More Info
Contact
+61861523788
Allison Barraclough
Principal Investigator
Sir Charles Gairdner Hospital
Nedlands Western Australia, 6009, Australia More Info
Contact
61893467600
Gavin Cull
Principal Investigator
Universitair Ziekenhuis Gent
Gent , 900, Belgium More Info
Contact
3293324912
Fritz Offner
Principal Investigator
Groupe Jolimont
Haine-Saint-Paul , 7100, Belgium More Info
Contact
3264234668
Vanessa Delrieu
Principal Investigator
CHU UCL Namur site Godinne
Yvoir , 5530, Belgium More Info
Contact
3281423831
Helen Vellemans
Principal Investigator
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada More Info
Contact
7803917601
Russell Sterrett
Principal Investigator
BC Cancer Vancouver
Vancouver British Columbia, V5Z4E, Canada More Info
Contact
6048776000
Alina Gerrie
Principal Investigator
Sunnybrook Health Sciences Centre
Toronto Ontario, M4N3M, Canada More Info
Contact
4164805000
David Spaner
Principal Investigator
Henan Provincial People's Hospital
Zhengzhou Henan, 45000, China More Info
Contact
18638110988
Xiaoli Yuan
Principal Investigator
Wu Han Tongji Hospital
Wuhan City Hubei, 43003, China More Info
Xiaoxi Zhou
Principal Investigator
Wuhan Union Hospital
Wuhan Hubei, 43002, China More Info
Contact
15172405695
Guohui Cui
Principal Investigator
Yichang Central People's Hospital
Yichang Hubei, 44300, China More Info
Contact
1386695594
Jingming Guo
Principal Investigator
The First Affiliated Hospital Of University Of South China
Hengshan Hunan, 42100, China More Info
Contact
18273430595
Junjun Li
Principal Investigator
Nantong Tumor Hospital
Nantong Jiangsu, 22636, China More Info
Contact
15162785205
Xiaohong Xu
Principal Investigator
Wuxi People's Hospital
Wuxi Jiangsu, 21402, China More Info
Contact
8615961770123
Xin zhou
Principal Investigator
Shengjing Hospital of China Medical University
Shenyang Liaoning, 11002, China More Info
Contact
8613504949706
Wei Yang
Principal Investigator
Jiangsu Province Hospital
Nanjing Nanjing, 21002, China More Info
Contact
8617718261400
Jianyong Li
Principal Investigator
The Affiliated Hospital of Qingdao University
Qingdao City Shandong, 26655, China More Info
Contact
8618171466443
Hongwei Xue
Principal Investigator
Shanghai Tongren Hospital
Changning District Shanghai, 20005, China More Info
Contact
19921055257
Ligen Liu
Principal Investigator
Tianjin Medical University Cancer Institute and Hospital
Tianjin Tianjin, 30006, China More Info
Contact
15022492653
Lihua Qiu
Principal Investigator
The First People's Hospital of Yunnan Province
Kunming Yunnan, 65003, China More Info
Contact
18213483624
Keqian Shi
Principal Investigator
First Affiliated Hosp of College of Med, Zhejiang University
Hangzhou Zhejiang, 31000, China More Info
Contact
8618724530827
Jie Jin
Principal Investigator
Chongqing Cancer Hospital
Chongqing , 40003, China More Info
Contact
15683801796
Ying Xiang
Principal Investigator
Fakultni nemocnice Brno
Brno , 62500, Czechia More Info
Contact
420532232158
Jiri Mayer
Principal Investigator
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia More Info
Contact
420495834016
Martin Simkovic
Principal Investigator
Fakultni nemocnice Kralovske Vinohrady
Praha 10 , 100 3, Czechia More Info
Contact
420267163672
Heidi Mocikova
Principal Investigator
Vseobecna fakultni nemocnice v Praze
Praha 2 , 12808, Czechia More Info
Contact
420224963117
Marek Trneny
Principal Investigator
Rigshospitalet
Copenhagen , 2100, Denmark More Info
Contact
+45 3545 9558
Caspar da Cunha-Bang
Principal Investigator
Hopital de la Pitie Salpetriere
Paris Cedex 13, 75651, France More Info
Contact
33142161596
Damien Roos-Weil
Principal Investigator
CHU de Nantes - Hôtel-Dieu
Nantes Cedex 1, 44093, France More Info
Contact
+33240165205
Anne Lok
Principal Investigator
Hôpital de Pontchaillou
Rennes Cedex 9, 35033, France More Info
Contact
33299286264
Sophie De Guibert
Principal Investigator
L'Institut Universitaire du Cancer de Toulouse Oncopole
Toulouse Cedex 9, 31100, France More Info
Contact
33531156337
Loic Ysebaert
Principal Investigator
Centre Hospitalier Lyon Sud
Pierre-Bénite Cedex, 69495, France More Info
Contact
33478864307
Emmanuelle Ferrant
Principal Investigator
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
Rouen Seine-Maritime, 76038, France More Info
Contact
33232082496
Stephane Lepretre
Principal Investigator
CHRU De Tours
Tours Tours Cedex 9, 37044, France More Info
Contact
33218370609
Caroline Dartigeas
Principal Investigator
Centre Hospitalier du Mans
Le Mans , 72000, France More Info
Contact
330253040492
Kamel Laribi
Principal Investigator
Hopital Saint Eloi
Montpellier Cedex , 34295, France More Info
Contact
33467332412
Guillaume Cartron
Principal Investigator
Pole Regionalde Cancérologie(CHU de Poitiers)
Politiers , 86021, France More Info
Contact
0516604209
Cecile Tomowiak
Principal Investigator
Chu De Nancy Hop D'Adultes De Brabois
Vandœuvre-lès-Nancy , 54500, France More Info
Contact
330383155234
Pierre Feugier
Principal Investigator
Rabin Medical Center
Petah-Tikva HaMerkaz, , Israel More Info
Contact
97239377927
Gilad Itchaki
Principal Investigator
Bnai Zion Medical Center
Haifa , 33394, Israel More Info
Contact
97248359588
Tamar Tadmor
Principal Investigator
Galilee Medical Center
Naharia , 22100, Israel More Info
Contact
97249107275
Galia Stemmer
Principal Investigator
Kaplan Medical Center
Reẖovot , 76100, Israel More Info
Contact
97289441393
Lev Shvidel
Principal Investigator
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel More Info
Contact
97236947802
Yair Herishanu
Principal Investigator
IRCCS - AOU di Bologna
Bologna , 40138, Italy More Info
Contact
390512143227
Pier Luigi Zinzani
Principal Investigator
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro , 88100, Italy More Info
Contact
0961883247
Luciano Levato
Principal Investigator
AOU Arcispedale Sant'Anna
Cona , 44124, Italy More Info
Contact
390532236979
Antonio Cuneo
Principal Investigator
Azienda Ospedaliera Universitaria Careggi
Firenze , 50134, Italy More Info
Contact
390557949183
Alessandro Sanna
Principal Investigator
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola , 47014, Italy More Info
Contact
390543739442
Gerardo Musuraca
Principal Investigator
IRCCS Ospedale San Raffaele
Milano , 20132, Italy More Info
Paolo Ghia
Principal Investigator
A.O.U. di Modena
Modena , 41224, Italy More Info
Contact
390594223160
Roberto Marasca
Principal Investigator
Azienda Ospedale Maggiore Della Carita
Novara , 28100, Italy More Info
Contact
390321660655
Gianluca Gaidano
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli
Roma , 00168, Italy More Info
Contact
393406754395
Luca Laurenti
Principal Investigator
A.O.U. Citta' della Salute e della Scienza di Torino
Torino , 10126, Italy More Info
Contact
390116334290
Marta Coscia
Principal Investigator
Nagoya Medical Center
Nagoya Aichi, 460-0, Japan More Info
Contact
81529511111
Hirokazu Nagai
Principal Investigator
Nagoya City University Hospital
Nagoya Aichi, 467-8, Japan More Info
Contact
81528587215
Shigeru Kusumoto
Principal Investigator
Hokkaido University Hospital
Sapporo Hokkaido, 060-8, Japan More Info
Contact
81117067600
Daigo Hashimoto
Principal Investigator
Kanagawa cancer center
Yokohama Kanagawa, 241-8, Japan More Info
Contact
81455202222
Rika Sakai
Principal Investigator
Kochi Medical School Hospital
Nankoku Kochi, 783-8, Japan More Info
Contact
81888802627
Kensuke Kojima
Principal Investigator
Kyoto Furitsu Medical University Hospital
Kyoto-shi Kyoto, 602-8, Japan More Info
Contact
81752515740
Junya Kuroda
Principal Investigator
Tohoku University Hospital
Sendai-shi Miyagi, 980-8, Japan More Info
Contact
81227177000
Noriko Fukuhara
Principal Investigator
Kindai University Hospital
Osaka Sayama-shi Osaka, 589 8, Japan More Info
Contact
81723660221
Itaru Matsumura
Principal Investigator
Saitama Medical Center
Kawagoe Saitama, 350-8, Japan More Info
Contact
81492283837
Masahiro Kizaki
Principal Investigator
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan More Info
Contact
81335475201
Suguru Fukuhara
Principal Investigator
Japanese Foundation for Cancer Research
Koto Tokyo, 135-8, Japan More Info
Contact
81335200111
Dai Maruyama
Principal Investigator
NTT Medical Center Tokyo
Shinagawa-Ku Tokyo, 141-8, Japan More Info
Contact
81334486111
Kensuke Usuki
Principal Investigator
University of Fukui Hospital
Fukui , 91011, Japan More Info
Contact
81776618529
Eiju Negoro
Principal Investigator
Kumamoto University Hospital
Kumamoto , 860-8, Japan More Info
Contact
81963735842
Hiro Tatetsu
Principal Investigator
Okayama University Hospital
Okayama , 700-8, Japan More Info
Contact
81862357991
Daisuke Ennishi
Principal Investigator
Severance Hospital, Yonsei University Health System
Seoul Seoul-teukbyeolsi [Seoul], 03722, Korea, Republic of More Info
Contact
82222284245
Jin Seok Kim
Principal Investigator
The Catholic University of Korea-Seoul St. Mary's Hospital
Seocho-Gu Seoul, 06591, Korea, Republic of More Info
Contact
821080604381
Ki-Seong Eom
Principal Investigator
Seoul National University Hospital
Seoul , 03080, Korea, Republic of More Info
Contact
821088838221
Junshik Hong
Principal Investigator
Samsung Medical Center
Seoul , 06351, Korea, Republic of More Info
Contact
821053620760
Won Seog Kim
Principal Investigator
Szpitale Pomorskie Sp. z o. o.
Gdynia Pomorskie, 81-51, Poland More Info
Contact
48587260380
Wanda Knopińska-Posłuszny
Principal Investigator
Pratia Onkologia Katowice
Katowice , 40519, Poland More Info
Contact
48501714089
Sabastian Grosicki
Principal Investigator
Pratia MCM Krakow
Krakow , 30-51, Poland More Info
Contact
48515687195
Wojciech Jurczak
Principal Investigator
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii
Łódź , 93510, Poland More Info
Contact
48426895583
Tadeusz Robak
Principal Investigator
Singapore General Hospital
Singapore , 16960, Singapore More Info
Contact
6563214627
Ong Shin Yeu
Principal Investigator
National Cancer Centre Singapore
Singapore , 16961, Singapore More Info
Contact
6596256407
Yi Ling Eileen Poon
Principal Investigator
Hospital Universitario de Toledo
Toledo Castilla La Mancha, 45004, Spain More Info
Contact
34925269243
Felipe Casado Montero
Principal Investigator
Hospital Puerta De Hierro
Majadahonda Madrid, 28222, Spain More Info
Contact
34911916880
Jose Antonio Garcia Marco
Principal Investigator
Hospital Costa Del Sol
Marbella Malaga, 29603, Spain More Info
Contact
34951976542
Angeles Medina Perez
Principal Investigator
Hospital Universitario Quironsalud Madrid
Madrid Pozuelo De Alarcón, 28223, Spain More Info
Contact
34914521900
Martinez Chamorro
Principal Investigator
Hospital Universitari Vall d'Hebron
Barcelona , 8035, Spain More Info
Contact
34932746000
Francesc Bosch Albareda
Principal Investigator
Hospital Universitario Fundación Jiménez Díaz
Madrid , 28040, Spain More Info
Raul Córdoba Mascuñano
Principal Investigator
Hospital Universitario Virgen del Rocío
Sevilla , 41013, Spain More Info
Contact
34955013277
Fatima De la Cruz
Principal Investigator
Hospital Universitari i Politecnic La Fe
Valencia , 46026, Spain More Info
Contact
34961246201
Rafael Andreu Lapiedra
Principal Investigator
Skanes Universitetssjukhus, Hematoloaimottagningen
Lund , 22185, Sweden More Info
Contact
4646176152
Daniel Roth
Principal Investigator
Kliniska forsknings- och utvecklingsenheten
Uppsala , 75185, Sweden More Info
Contact
46186115047
Mattias Mattsson
Principal Investigator
Ospedale Regionale Bellinzona e Valli
Bellinzona Ticino, 6500, Switzerland More Info
Contact
41918118540
Davide Rossi
Principal Investigator
Luzerner Kantonsspital
Luzern , 6000, Switzerland More Info
Contact
41412051803
Michael Gregor
Principal Investigator
Chang Gung Memorial Hospital - Linkou
Guei Shan Township Taoyuan City, 333, Taiwan More Info
Contact
88633281200
Hsuan-Jen Shih
Principal Investigator
National Taiwan University Hospital
Taipei , 10002, Taiwan More Info
Shang-Ju Wu
Principal Investigator
Derriford Hospital
Plymouth Devon, PL6 8, United Kingdom More Info
Contact
01752432007
Claire Hutchinson
Principal Investigator
Leicester Royal Infirmary
Leicester England, LE15W, United Kingdom More Info
Contact
01162585951
Rebecca Allchin
Principal Investigator
Churchill Hospital
Oxford , OX3 7, United Kingdom More Info
Contact
441865572048
Toby Eyre
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

600

Study ID:

NCT04965493

Recruitment Status:

Recruiting

Sponsor:


Loxo Oncology, Inc.

How clear is this clinincal trial information?

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