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.
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
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There are 188 Locations for this study
Phoenix Arizona, 85054, United States More Info
Principal Investigator
Tucson Arizona, 85724, United States More Info
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Orange California, 92868, United States More Info
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San Diego California, 92103, United States More Info
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San Diego California, 92123, United States More Info
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Santa Rosa California, 95403, United States More Info
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Stamford Connecticut, 06904, United States More Info
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Fort Myers Florida, 33916, United States More Info
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Jacksonville Florida, 32256, United States More Info
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Saint Petersburg Florida, 33705, United States More Info
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Tallahassee Florida, 32308, United States More Info
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West Palm Beach Florida, 33401, United States More Info
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Urbana Illinois, 61801, United States More Info
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Garden City Kansas, 67846, United States More Info
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Pikeville Kentucky, 41501, United States More Info
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Baton Rouge Louisiana, 70809, United States More Info
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Bethesda Maryland, 20817, United States More Info
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Boston Massachusetts, 02215, United States More Info
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Ann Arbor Michigan, 48109, United States More Info
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Detroit Michigan, 48201, United States More Info
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Rochester Minnesota, 55905, United States More Info
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Bolivar Missouri, 65613, United States More Info
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Kansas City Missouri, 63142, United States More Info
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Basking Ridge New Jersey, 07920, United States More Info
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Hackensack New Jersey, 07601, United States More Info
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Middletown New Jersey, 07748, United States More Info
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Montvale New Jersey, 07645, United States More Info
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Morristown New Jersey, 07962, United States More Info
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Commack New York, 11725, United States More Info
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Harrison New York, 10604, United States More Info
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New York New York, 10032, United States More Info
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New York New York, 10065, United States More Info
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New York New York, 10128, United States More Info
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New York New York, 10532, United States More Info
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Syracuse New York, 13210, United States More Info
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Uniondale New York, 11553, United States More Info
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Charlotte North Carolina, 28204, United States More Info
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Charlotte North Carolina, 28204, United States More Info
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Durham North Carolina, 27705, United States More Info
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Columbus Ohio, 43210, United States More Info
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Chattanooga Tennessee, 37404, United States More Info
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Nashville Tennessee, 37203, United States More Info
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Houston Texas, 77030, United States More Info
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Houston Texas, 77030, United States More Info
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Round Rock Texas, 78665, United States More Info
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Charlottesville Virginia, 22903, United States More Info
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Seattle Washington, 98104, United States More Info
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Spokane Washington, 99218, United States More Info
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Waukesha Wisconsin, 53188, United States More Info
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Albury New South Wales, 2640, Australia More Info
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Concord New South Wales, 2139, Australia More Info
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Adelaide South Australia, 5000, Australia More Info
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Adelaide South Australia, 5042, Australia More Info
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Hobart Tasmania, 7000, Australia More Info
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Frankston Victoria, 3199, Australia More Info
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Murdoch Western Australia, 6150, Australia More Info
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Nedlands Western Australia, 6009, Australia More Info
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Haine-Saint-Paul , 7100, Belgium More Info
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Calgary Alberta, T2N4N, Canada More Info
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Edmonton Alberta, T6G 1, Canada More Info
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Vancouver British Columbia, V5Z4E, Canada More Info
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Winnipeg Manitoba, R3E 0, Canada More Info
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Toronto Ontario, M4N3M, Canada More Info
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Montreal Quebec, H3T 1, Canada More Info
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Hefei Anhui, 23002, China More Info
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Beijing Beijing, 10003, China More Info
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Guangzhou Guangdong, 51000, China More Info
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Zhongshan Guangdong, 52840, China More Info
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Nanning Guangxi, 53002, China More Info
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Zhengzhou Henan, 45000, China More Info
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Wuhan City Hubei, 43003, China More Info
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Wuhan Hubei, 43002, China More Info
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Yichang Hubei, 44300, China More Info
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Changsha Hunan, 41001, China More Info
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Hengshan Hunan, 42100, China More Info
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Hohhot Inner Mongolia, 10050, China More Info
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Nanchang Jiangxi, 33002, China More Info
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Shenyang Liaoning, 11002, China More Info
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Nanjing Nanjing, 21002, China More Info
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Qingdao City Shandong, 26655, China More Info
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Changning District Shanghai, 20005, China More Info
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Shanghai Shanghai, 20002, China More Info
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Tianjin Tianjin, 30006, China More Info
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Tel Aviv , 64239, Israel More Info
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Catanzaro , 88100, Italy More Info
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Firenze , 50134, Italy More Info
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Meldola , 47014, Italy More Info
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Novara , 28100, Italy More Info
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Roma , 00168, Italy More Info
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Torino , 10126, Italy More Info
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Nagoya Aichi, 467-8, Japan More Info
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Sapporo Hokkaido, 060-8, Japan More Info
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Nankoku Kochi, 783-8, Japan More Info
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Kyoto-shi Kyoto, 602-8, Japan More Info
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Sendai-shi Miyagi, 980-8, Japan More Info
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Osaka Sayama-shi Osaka, 589 8, Japan More Info
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Kawagoe Saitama, 350-8, Japan More Info
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Chuo-ku Tokyo, 104-0, Japan More Info
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Koto Tokyo, 135-8, Japan More Info
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Shinagawa-Ku Tokyo, 141-8, Japan More Info
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Seoul Seoul-teukbyeolsi [Seoul], 03722, Korea, Republic of More Info
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Seocho-Gu Seoul, 06591, Korea, Republic of More Info
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Seoul , 03080, Korea, Republic of More Info
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Seoul , 06351, Korea, Republic of More Info
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Gdynia Pomorskie, 81-51, Poland More Info
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Katowice , 40519, Poland More Info
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Åódź , 93510, Poland More Info
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Singapore , 16960, Singapore More Info
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Singapore , 16961, Singapore More Info
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Toledo Castilla La Mancha, 45004, Spain More Info
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Majadahonda Madrid, 28222, Spain More Info
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Marbella Malaga, 29603, Spain More Info
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Madrid Pozuelo De Alarcón, 28223, Spain More Info
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Barcelona , 8035, Spain More Info
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Madrid , 28040, Spain More Info
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Sevilla , 41013, Spain More Info
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Valencia , 46026, Spain More Info
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Lund , 22185, Sweden More Info
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Uppsala , 75185, Sweden More Info
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Bellinzona Ticino, 6500, Switzerland More Info
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Guei Shan Township Taoyuan City, 333, Taiwan More Info
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Taipei , 10002, Taiwan More Info
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Plymouth Devon, PL6 8, United Kingdom More Info
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Leicester England, LE15W, United Kingdom More Info
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