Chronic Lymphocytic Leukemia Clinical Trial
Study of LOXO-305 Versus Investigator’s Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Summary
This is a study for patients with leukemia-cll/" >chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.
Full Description
This is a Phase 3 global, randomized, open-label study comparing LOXO-305 (Arm A) to investigator's choice of either idelalisib plus rituximab or bendamustine plus rituximab (Arm B) in CLL/SLL patients who have been treated with at least a covalent BTK inhibitor (BTKi). Patients may have discontinued the prior covalent BTKi due to disease progression (PD) or intolerance. Patients who have received venetoclax are eligible for the study. Eligible patients will be randomized in 1:1 to Arm A and Arm B.
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of CLL/SLL requiring therapy as defined by iwCLL 2018 criteria.
Previously treated with a covalent BTK inhibitor.
Eastern Cooperative Oncology Group (ECOG) 0-2.
Absolute neutrophil count ≥ 0.75 × 10^9/L without granulocyte-colony-stimulating factor support, or ≥ 0.50 × 10^9/L in patients with documented bone marrow involvement considered to impair hematopoiesis. Granulocyte-colony-stimulating factor support is permitted in patients with documented bone marrow involvement.
Hemoglobin ≥ 8 g/dL or ≥ 6 g/dL in patients with documented bone marrow involvement considered to impair hematopoiesis. Transfusion support is permitted in patients with bone marrow involvement.
Platelets ≥ 50 × 10^9/L. If an investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be ≥ 75 × 10^9/L. Patients may enroll below these thresholds if the Investigator determines the cytopenia is related to bone marrow involvement considered to impair hematopoiesis. Patients with a platelet count < 30 x 10^9/L are excluded.
AST and ALT ≤ 3.0 x upper limit of normal (ULN).
Total bilirubin ≤ 1.5 x ULN.
Estimated creatinine clearance of ≥ 30 mL/min.
Exclusion Criteria:
Known or suspected Richter's transformation at any time preceding enrollment.
Known or suspected history of central nervous system (CNS) involvement by CLL/SLL.
Ongoing drug-induced liver injury.
Active uncontrolled auto-immune cytopenia.
Significant cardiovascular disease.
History of allogeneic or stem cell transplantation (SCT) or chimeric antigen receptor-modified T cells (CAR-T) therapy within the past 60 days.
Active hepatitis B or hepatitis C.
Known active cytomegalovirus (CMV) infection.
Active uncontrolled systemic bacterial, viral, fungal or parasitic infection.
Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count.
Clinically significant active malabsorption syndrome or inflammatory bowel disease
Prior exposure to 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.
Vaccination with a live vaccine within 28 days prior to randomization.
Patients with the following hypersensitivity:
Known hypersensitivity, including anaphylaxis, to any component or excipient of LOXO-305. For patients planned to receive idelalisib, known hypersensitivity, including anaphylaxis, to any component or excipient of idelalisib. For patients planned to receive bendamustine, known hypersensitivity, including anaphylaxis, to any component or excipient of bendamustine.
Prior significant hypersensitivity to rituximab.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 222 Locations for this study
Daphne Alabama, 36526, United States
Mobile Alabama, 36604, United States
Glendale Arizona, 85304, United States
Tucson Arizona, 85711, United States
Fountain Valley California, 92708, United States
Los Angeles California, 90027, United States
Aurora Colorado, 80012, United States
Newark Delaware, 19713, United States
Boca Raton Florida, 33486, United States
Jacksonville Florida, 32256, United States
Tamarac Florida, 33321, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60612, United States
Niles Illinois, 60714, United States
Indianapolis Indiana, 46250, United States
Lafayette Indiana, 47904, United States
Lexington Kentucky, 40563, United States
Louisville Kentucky, 40207, United States
Paducah Kentucky, 42003, United States
New Orleans Louisiana, 70112, United States
Baltimore Maryland, 21201, United States
Ann Arbor Michigan, 48106, United States
Grosse Pointe Woods Michigan, 48236, United States
Saint Paul Minnesota, 55102, United States
Billings Montana, 59102, United States
Lincoln Nebraska, 68506, United States
Brick New Jersey, 08724, United States
New York New York, 10021, United States
Rochester New York, 14642, United States
Westbury New York, 11590, United States
Cincinnati Ohio, 45236, United States
Eugene Oregon, 97401, United States
Rock Hill South Carolina, 29732, United States
Amarillo Texas, 79106, United States
Austin Texas, 78705, United States
Dallas Texas, 75230, United States
Dallas Texas, 75231, United States
Fort Sam Houston Texas, 78234, United States
Fort Worth Texas, 76104, United States
Fort Worth Texas, 76104, United States
McAllen Texas, 78503, United States
San Antonio Texas, 78240, United States
Gainesville Virginia, 20155, United States
Roanoke Virginia, 24014, United States
Tacoma Washington, 98405, United States
Madison Wisconsin, 53705, United States
Garran Australian Capital Territory, 2605, Australia
Darlinghurst New South Wales, 2010, Australia
Kogarah New South Wales, 2217, Australia
Liverpool New South Wales, NSW21, Australia
Wentworthville New South Wales, 2145, Australia
Melbourne Victoria, 3004, Australia
Perth Western Australia, 6000, Australia
Linz Oberösterreich, 4020, Austria
Salzburg Osterreich, 5020, Austria
Wien , 1090, Austria
Verviers Liege, 4800, Belgium
Sint-Niklaas Oost-Vlaanderen, B-910, Belgium
Roeselare West Flanders, 8800, Belgium
Gent , 9000, Belgium
Haine-Saint-Paul , 7100, Belgium
Herentals , 2200, Belgium
Ottignies , 1340, Belgium
Winnipeg Manitoba, R3E 0, Canada
Halifax Nova Scotia, B3H 1, Canada
Newmarket Ontario, L3Y 2, Canada
Toronto Ontario, M5G 1, Canada
Beijing Beijing, 10003, China More Info
Principal Investigator
Beijing Beijing, 10019, China More Info
Principal Investigator
Xicheng District Beijing, 10005, China More Info
Principal Investigator
Guangzhou Guangdong, 51000, China More Info
Principal Investigator
Guangzhou Guangdong, 51051, China More Info
Principal Investigator
Haikou Hainan, 57010, China More Info
Principal Investigator
Xuzhou Jiangsu, 22100, China More Info
Principal Investigator
Nanchang Jiangxi, 33000, China More Info
Principal Investigator
Nanchang Jiangxi, 33000, China More Info
Principal Investigator
Tianjin Tianjin, , China More Info
Principal Investigator
Ürümqi Xinjiang, 83000, China More Info
Principal Investigator
Hangzhou Zhejiang, 31002, China More Info
Principal Investigator
Linhai Zhejiang, 31700, China More Info
Principal Investigator
Shanghai , 20002, China More Info
Principal Investigator
Shanghai , 20003, China More Info
Principal Investigator
Tianjin , 30002, China More Info
Principal Investigator
Split , 21000, Croatia
Zagreb , , Croatia
Brno , 62500, Czechia
Hradec Kralove , 500 0, Czechia
Praha 2 , 12808, Czechia
Grenoble Cedex 09, 38043, France
Bobigny Cedex, 93 00, France
Pierre Benite Cedex, 69495, France
La Roche-sur-Yon La Roche Sur Yon, 85000, France
Nîmes Nimes, 30900, France
Rouen Seine-Maritime, 76038, France
Tours Tours Cedex 9, 37044, France
Bayonne , 64109, France
Bordeaux , 33076, France
Brest cedex , 29609, France
Le Mans , 72000, France
Lille cedex , 59020, France
Perpignan , 66046, France
Politiers , 86021, France
Heidelberg Baden-Württemberg, 69120, Germany
Ulm Baden-Württemberg, 89081, Germany
Kerpener Köln, 50937, Germany
Langenbeckstraße 1 Mainz, D- 55, Germany
Koelner Platz 1 München, 80804, Germany
Kiel Schleswig-Holstein, 24105, Germany
Lübeck Schleswig-Holstein, 23562, Germany
Berlin , 12203, Germany
Budapest , 1097, Hungary
Debrecen , 4032, Hungary
Nyiregyhaza , 4400, Hungary
Pecs , 7624, Hungary
Dublin 7 , , Ireland
Dublin 8 , D08 N, Ireland
Dublin , DUBLI, Ireland
Petah Tikva HaMerkaz, , Israel
Beer Sheva , 84571, Israel
Netanya , 42449, Israel
Tel Aviv , 64239, Israel
Haifa Ḥeifā, 34362, Israel
Viale Orazio Flacco Bari, 70124, Italy
Monza (MB) -Settore E Piano 2, 20900, Italy
Pisa PI, 56126, Italy
Rionero In Vulture Potenza, 85028, Italy
Vicenza Veneto, 36100, Italy
Alessandria , 15100, Italy
Bergamo , 24127, Italy
Brescia , 25123, Italy
Catania , 95123, Italy
Catanzaro , 88100, Italy
Firenze , 50134, Italy
Genova , 16132, Italy
Messina , 98158, Italy
Milano , 20132, Italy
Milano , 20162, Italy
Modena , 41124, Italy
Pavia , 27100, Italy
Perugia , 06132, Italy
Ravenna , 48020, Italy
Roma , 00168, Italy
Terni , 05100, Italy
Torino , 10126, Italy
Tricase , 4 - 7, Italy
Trieste , 34125, Italy
Verona , 37134, Italy
Nagoya Aichi, 460-0, Japan
Nagoya Aichi, 464-8, Japan
Nagoya Aichi, 467-8, Japan
Ogaki-shi Gifu, 503-8, Japan
Sapporo Hokkaido, 060-8, Japan
Kobe Hyogo, 650-0, Japan
Isehara Kanagawa, 259-1, Japan
Nankoku Kochi, 783-8, Japan
Sendai-shi Miyagi-Ken, 983-8, Japan
Sendai-shi Miyagi, 980-8, Japan
Osaka Sayama-shi Osaka, 589 8, Japan
Kawagoe Saitama, 350-8, Japan
Koto Tokyo, 135-8, Japan
Shinagawa-Ku Tokyo, 141-8, Japan
Fukoka-ken , 806 8, Japan
Kumamoto , 860-8, Japan
Okayama , 700-8, Japan
Osaka , 565-0, Japan
Namdong-gu Incheon-gwangyeoksi [Incheon], 21565, Korea, Republic of
Busan Pusan-Kwangyǒkshi, 49241, Korea, Republic of
Seoul Seoul, Korea, 03080, Korea, Republic of
Seoul Seoul-teukbyeolsi [Seoul], 03722, Korea, Republic of
Seocho-Gu Seoul, 06591, Korea, Republic of
Busan , 47392, Korea, Republic of
Iwaszkiewicza 5 Legnica, 59-22, Poland
Lublin Lubelskie, 20-08, Poland
Gdansk Pomorskie, 80-21, Poland
Gdynia Pomorskie, 81-51, Poland
Brzozów , 36-20, Poland
Bydgoszcz , 85-16, Poland
Katowice , 40519, Poland
Krakow , 30-51, Poland
Walbrzych , 58-30, Poland
Warszawa , 02-77, Poland
Warszawa , 02-78, Poland
Wrocław , 50-36, Poland
Łódź , 93510, Poland
Omsk Omskaya Oblast', 64401, Russian Federation
Saint Petersburg , 19102, Russian Federation
Saint Petersburg , 19702, Russian Federation
Sochi , 35405, Russian Federation
Singapore Central Singapore, 25849, Singapore
Hospitalet De Llobregat Barcelona, 08908, Spain
Toledo Castilla La Mancha, 45004, Spain
Santiago de Compostela La Coruna, 15706, Spain
Madrid Madrid, Comunidad De, 28034, Spain
Pozuelo De Alarcón Madrid, 28223, Spain
Madrid Planta Baja, 28007, Spain
Albacete , 02006, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Caceres , 10003, Spain
Madrid , 28031, Spain
Madrid , 28046, Spain
Santander , 39008, Spain
Sevilla , 41013, Spain
Vitoria , 01005, Spain
Bellinzona Svizzera, 6500, Switzerland
Taichung City Taichung, 40447, Taiwan
Taipei City Taipei, 114, Taiwan
Taipei City , 11220, Taiwan
Taoyuan, (r.o.c.) , 33342, Taiwan
Mamak Ankara, , Turkey
Faith Istanbul, , Turkey
Kayseri Melikgazi, 38039, Turkey
Ankara Yenimahalle, 06560, Turkey
Izmir , 35100, Turkey
Izmir , 35330, Turkey
Aberdeen Aberdeen City, AB25 , United Kingdom
Truro Cornwall, TR1 3, United Kingdom
Plymouth Devon, PL6 8, United Kingdom
Cottingham East Yorkshire, HU16 , United Kingdom
London Greater London, WC1E , United Kingdom
Norwich Norfolk, NR4 7, United Kingdom
Swansea Sa2 8qa, , United Kingdom
Edinburgh Scotland, EH4 2, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Livingston West Lothian, EH54 , United Kingdom
Leeds , LS9 7, United Kingdom
Milton Keynes , MK6 5, United Kingdom
Newmarket , CB8 7, United Kingdom
How clear is this clinincal trial information?