Phase
Condition
Lymphoma
Lymphoma, B-cell
Treatment
Copanlisib (Aliqopa, BAY80-6946)
Placebo
Rituximab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed diagnosis of Indolent non-Hodgkin's lymphoma (iNHL) in CD20positive patients, with histological subtype limited to:
Follicular lymphoma(FL) grade1-2-3a
Small lymphocytic lymphoma(SLL) with absolute lymphocyte count <5x10*9/L atstudy entry
Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
Patients must have relapsed (recurrence after complete response or presentedprogression after partial response) after the last rituximab-, rituximabbiosimilars-, or anti-CD20 monoclonal antibody (e.g. obinutuzumab)-containingtherapy (other previous treatment lines after rituximab are allowed). A previousregimen is defined as one of the following: at least 2 months of single-agenttherapy (less than 2 months of therapy is allowed for patients who responded tosingle-agent rituximab, rituximab biosimilars, or anti-CD20 monoclonal antibody); atleast 2 consecutive cycles of polychemotherapy; autologous transplant;radioimmunotherapy. Previous exposure to PI3K is acceptable (except to copanlisib)provided there is no resistance. Patients with prior intolerance to PI3K inhibitorsother than copanlisib are eligible.
Non-WM must have at least one bi-dimensionally measurable lesion (which has not beenpreviously irradiated) according to the Lugano Classification. For patients withsplenic MZL (Marginal-zone lymphoma) this requirement may be restricted tosplenomegaly alone since that is usually the only manifestation of measurabledisease.
Patients affected by WM who do not have at least one bi-dimensionally measurablelesion in the baseline radiologic assessment must have measurable disease, definedas presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level ≥ 2 xupper limit of normal (ULN) and positive immunofixation test .
Male or female patients ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Life expectancy of at least 3 months
Availability of fresh tumor tissue and/or archival tumor tissue for centralpathology(obtained within 5 years of the consent date) at Screening
Adequate baseline laboratory values collected no more than 7 days before startingstudy treatment
Left ventricular ejection fraction ≥ 45%
Patients must either:
have had a progression-free and treatment-free interval of at least 12 monthsafter completion of the rituximab-, rituximab biosimilars-, or anti-CD20monoclonal antibody-containing treatment OR
be considered unfit to receive chemotherapy on reason of age, concomitantmorbidities, and/or residual toxicity from previous treatments, orunwillingness to receive chemotherapy. These patients must also have had aprogression-free and treatment-free interval of at least 6 months aftercompletion of the last rituximab-, rituximab biosimilars-, or anti-CD20monoclonal antibody-containing treatment. Patients in whom chemotherapy iscontraindicated are defined by one of the following features:
Age ≥ 80 years
Age < 80 years and at least 1 of the following conditions:
at least 3 grade 3 CIRS-G comorbidities OR
at least 1 grade 4 CIRS-G comorbidity (if compatible to participationin the study).
Exclusion
Exclusion Criteria:
Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformeddisease, or chronic lymphocytic leukemia
Progression free interval or treatment free interval of less than 12 months sincethe last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody (e.g.obinutuzumab)-containing treatment(including maintenance with these drugs). Forpatients considered unwilling/unfit to receive chemotherapy : progression freeinterval or treatment free interval of less than 6 months since the last rituximab-,rituximab biosimilars-, or anti-CD20 monoclonal antibody-containing treatment (including maintenance with these drugs), as assessed by the investigator
History or concurrent condition of interstitial lung disease of any severity and/orseverely impaired lung function
Known lymphomatous involvement of the central nervous system
Patients with HbA1c > 8.5% at Screening
Known history of human immunodeficiency virus (HIV) infection
Hepatitis B (HBV) or hepatitis C (HCV). Patients positive for HBsAg or HBcAb will beeligible if they are negative for HBV-DNA, these patients should receiveprophylactic antiviral therapy. Patients positive for anti- HCV antibody will beeligible if they are negative for HCV-RNA
Documented evidence of resistance to prior treatment with idelalisib or other PI3Kinhibitors.
Prior treatment with copanlisib
Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline willnot be eligible.
Study Design
Connect with a study center
Buenos Aires, Ciudad Auton. De Buenos Aires TBC
ArgentinaSite Not Available
empty
Cordoba, Ciudad Auton. de Buenos Aires X5000JHQ
ArgentinaSite Not Available
Rosario, Santa Fe S2000DEJ
ArgentinaSite Not Available
San Miguel de Tucumán, Tucuman T4000
ArgentinaSite Not Available
empty
Ciudad Auton. de Buenos Aires, C1114AAN
ArgentinaSite Not Available
Córdoba, X5000AOQ
ArgentinaSite Not Available
empty
Kogarah, New South Wales 2217
AustraliaSite Not Available
empty
Orange, New South Wales 2800
AustraliaSite Not Available
empty
Waratah, New South Wales 2298
AustraliaSite Not Available
Ballarat, Victoria 3350
AustraliaSite Not Available
empty
Kingswood, 2747
AustraliaSite Not Available
Nedlands, 6009
AustraliaSite Not Available
Graz, Steiermark 8036
AustriaSite Not Available
empty
Leoben, Steiermark 8700
AustriaSite Not Available
Landeskrankenhaus Rankweil
Rankweil, Vorarlberg 6830
AustriaSite Not Available
empty
Innsbruck, 6020
AustriaSite Not Available
empty
Krems, 3500
AustriaSite Not Available
empty
Linz, 4020
AustriaSite Not Available
empty
Salzburg, 5020
AustriaSite Not Available
Wien, 1090
AustriaSite Not Available
empty
Lesnoy, 223040
BelarusSite Not Available
empty
Minsk, 220013
BelarusSite Not Available
empty
Bruxelles - Brussel, 1020
BelgiumSite Not Available
empty
Gent, 9000
BelgiumSite Not Available
empty
Kortrijk, 8500
BelgiumSite Not Available
Ottignies, 1340
BelgiumSite Not Available
empty
Turnhout, 2300
BelgiumSite Not Available
empty
Verviers, 4800
BelgiumSite Not Available
Passo Fundo, Rio Grande Do Sul 99020-240
BrazilSite Not Available
Porto Alegre, Rio Grande Do Sul 90850-170
BrazilSite Not Available
empty
Ijuí, Rio Grande do Sul 98700-000
BrazilSite Not Available
empty
Barretos, Sao Paulo 14784-400
BrazilSite Not Available
Barretos, Sao Paulo 14784-400
BrazilSite Not Available
Barretos/SP, Sao Paulo 14784-400
BrazilSite Not Available
Jaú, Sao Paulo 17210-120
BrazilSite Not Available
São Paulo, Sao Paulo 08270-070
BrazilSite Not Available
empty
Brazil,
BrazilSite Not Available
empty
Rio de Janeiro, 22793-080
BrazilSite Not Available
Sao Paulo, 05651-901
BrazilSite Not Available
Plovdiv, 4000
BulgariaSite Not Available
Sofia, 1756
BulgariaSite Not Available
Varna, 9010
BulgariaSite Not Available
Temuco, Araucanía 4800827
ChileSite Not Available
empty
Santiago, 833-0024
ChileSite Not Available
empty
Hefei, Anhui 230001
ChinaSite Not Available
Fuzhou, Fujian 350000
ChinaSite Not Available
Guangzhou, Guangdong 510000
ChinaSite Not Available
empty
Zhengzhou, Henan 450052
ChinaSite Not Available
Wuhan, Hubei 430079
ChinaSite Not Available
Nanjing, Jiangsu 210000
ChinaSite Not Available
Suzhou, Jiangsu 215000
ChinaSite Not Available
Nanchang, Jiangxi 330029
ChinaSite Not Available
empty
Changchun, Jilin 130000
ChinaSite Not Available
Changchun, Jilin 130000
ChinaSite Not Available
Changchun City, Jilin 130061
ChinaSite Not Available
Shengyang, Liaoning 110042
ChinaSite Not Available
Chengdu, Sichuan 610041
ChinaSite Not Available
empty
Yibin, Sichuan 644000
ChinaSite Not Available
empty
Urumchi, Xinjiang
ChinaSite Not Available
Urumqi, Xinjiang 830011
ChinaSite Not Available
Hangzhou, Zhejiang 310000
ChinaSite Not Available
Beijing, 100083
ChinaSite Not Available
empty
China,
ChinaSite Not Available
Chongqing, 400042
ChinaSite Not Available
empty
Harbin,
ChinaSite Not Available
Shanghai, 200000
ChinaSite Not Available
Tianjin, 300000
ChinaSite Not Available
empty
Bogota, Antioquia
ColombiaSite Not Available
Medellin, Antioquia 050034
ColombiaSite Not Available
empty
Medellín, Antioquia 050034
ColombiaSite Not Available
Medellín, Antioquia 050034
ColombiaSite Not Available
empty
Barranquilla, Atlántico
ColombiaSite Not Available
Bogota, Cundinamarca 111511
ColombiaSite Not Available
empty
Bogotá, Cundinamarca 111511
ColombiaSite Not Available
Bogotá, Cundinamarca 111511
ColombiaSite Not Available
Montería, Córdoba 230002
ColombiaSite Not Available
empty
Bucaramanga, Santander
ColombiaSite Not Available
empty
Floridablanca, Santander 681004
ColombiaSite Not Available
Cali, Valle Del Cauca 760032
ColombiaSite Not Available
empty
Aalborg, 9100
DenmarkSite Not Available
empty
Aarhus C, 8000
DenmarkSite Not Available
empty
Copenhagen, 2100
DenmarkSite Not Available
empty
Odense C, 5000
DenmarkSite Not Available
empty
Roskilde, DK-4000
DenmarkSite Not Available
Bayonne, 64100
FranceSite Not Available
Brest, 29470
FranceSite Not Available
empty
Caen, 14033
FranceSite Not Available
empty
Limoges, 87042
FranceSite Not Available
Metz Cedex 03, 57085
FranceSite Not Available
NICE Cedex 2, 06189
FranceSite Not Available
empty
Nantes, 44805
FranceSite Not Available
Nantes, 44805
FranceSite Not Available
Nice Cedex 2, 6189
FranceSite Not Available
empty
Perigueux, 24019
FranceSite Not Available
Pessac, 33600
FranceSite Not Available
Poitiers, 86021
FranceSite Not Available
Saint-Herblain, 44800
FranceSite Not Available
empty
Vandoeuvre-les-nancy, 54511
FranceSite Not Available
empty
Landshut, Bayern 84028
GermanySite Not Available
München, Bayern 81377
GermanySite Not Available
empty
Potsdam, Berlin 14467
GermanySite Not Available
empty
Aschaffenburg, Nordrhein-Westfalen 63739
GermanySite Not Available
Recklinghausen, Nordrhein-Westfalen 45659
GermanySite Not Available
empty
Chemnitz, Sachsen 09116
GermanySite Not Available
Dresden, Sachsen 1307
GermanySite Not Available
Halle, Sachsen-Anhalt 6120
GermanySite Not Available
empty
Halle (Saale), Sachsen-Anhalt 06097
GermanySite Not Available
Berlin, 10967
GermanySite Not Available
empty
Hamburg, 22081
GermanySite Not Available
empty
Ulm, 89081
GermanySite Not Available
empty
Haidari, Attica 12462
GreeceSite Not Available
Athens, 11527
GreeceSite Not Available
Chaidari, 12462
GreeceSite Not Available
empty
Larissa, 41100
GreeceSite Not Available
empty
Patra, 26500
GreeceSite Not Available
Patras, 26500
GreeceSite Not Available
empty
Piraeus, 18 537
GreeceSite Not Available
empty
Rio / Patra, 26500
GreeceSite Not Available
empty
Thessaloniki, 570 10
GreeceSite Not Available
Chai Wan, 0
Hong KongSite Not Available
Hong Kong, MISSING
Hong KongSite Not Available
empty
Kowloon,
Hong KongSite Not Available
empty
New Territories,
Hong KongSite Not Available
empty
Shatin, MISSING
Hong KongSite Not Available
Shatin,
Hong KongSite Not Available
Budapest, 1083
HungarySite Not Available
Gyor, 9024
HungarySite Not Available
Kaposvar, 7400
HungarySite Not Available
Pecs, 7623
HungarySite Not Available
empty
Tata, 2890
HungarySite Not Available
Tatabanya, 2800
HungarySite Not Available
Dublin, D08NHY1
IrelandSite Not Available
empty
Dublin 4,
IrelandSite Not Available
Galway, H91YR71
IrelandSite Not Available
empty
Pordenone, Friuli-Venezia Giulia 33081
ItalySite Not Available
Udine, Friuli-Venezia Giulia 33038
ItalySite Not Available
Genova, Liguria 16132
ItalySite Not Available
Milano, Lombardia 20133
ItalySite Not Available
empty
Rozzano, Milano 20089
ItalySite Not Available
empty
Aviano, Pordenone 33081
ItalySite Not Available
Firenze, Toscana 50134
ItalySite Not Available
empty
Bergamo, 24127
ItalySite Not Available
empty
Bologna, 40138
ItalySite Not Available
empty
Cagliari, 09121
ItalySite Not Available
Nagoya, Aichi 466-8650
JapanSite Not Available
empty
Matsuyama, Ehime 791-0280
JapanSite Not Available
Maebashi, Gunma 371-8511
JapanSite Not Available
empty
Akashi, Hyogo 673-8558
JapanSite Not Available
Kobe, Hyogo 650-0047
JapanSite Not Available
Nankoku, Kochi 783-8505
JapanSite Not Available
empty
Tsu, Mie 514-8507
JapanSite Not Available
Sendai, Miyagi 980-8574
JapanSite Not Available
empty
Matsumoto, Nagano 390-8621
JapanSite Not Available
Omura, Nagasaki 856-8562
JapanSite Not Available
Kurashiki, Okayama 710-8602
JapanSite Not Available
Hirakata, Osaka 573-1191
JapanSite Not Available
empty
Moriguchi, Osaka 570-8540
JapanSite Not Available
Izumo, Shimane 693-8501
JapanSite Not Available
empty
Shimotsuke, Tochigi 329-0498
JapanSite Not Available
Chuo-ku, Tokyo 104-0045
JapanSite Not Available
empty
Komae, Tokyo 201-8601
JapanSite Not Available
empty
Shinagawa-ku, Tokyo 141-8625
JapanSite Not Available
Aomori, 030-8553
JapanSite Not Available
empty
Chiba, 260-8717
JapanSite Not Available
Fukuoka, 811-1395
JapanSite Not Available
Kumamoto, 860-8556
JapanSite Not Available
Niigata, 951-8566
JapanSite Not Available
empty
Okayama, 700-8558
JapanSite Not Available
Osaka, 545-8586
JapanSite Not Available
Yamagata, 990-9585
JapanSite Not Available
Seoul, Seoul Teugbyeolsi 03722
Korea, Republic ofSite Not Available
Busan, 49201
Korea, Republic ofSite Not Available
Hwasun Gun, 58128
Korea, Republic ofSite Not Available
empty
Jeollanam-do, 58128
Korea, Republic ofSite Not Available
Jeollanam-do, 58128
Korea, Republic ofSite Not Available
Kaunas, LT-50009
LithuaniaSite Not Available
empty
Esch-sur-alzette, 4240
LuxembourgSite Not Available
empty
Luxembourg, 1210
LuxembourgSite Not Available
Cheras, 56000
MalaysiaSite Not Available
empty
Ipoh,
MalaysiaSite Not Available
empty
Kelantan,
MalaysiaSite Not Available
Kota Kinabalu, 88586
MalaysiaSite Not Available
Kuala Lumpur, 59100
MalaysiaSite Not Available
Perak, 30450
MalaysiaSite Not Available
Pulau Pinang, 10450
MalaysiaSite Not Available
Selangor, 68000
MalaysiaSite Not Available
empty
México, D.F., Distrito Federal 06720
MexicoSite Not Available
Morelia, Michoacán 58260
MexicoSite Not Available
Monterrey, Nuevo Leon TBC
MexicoSite Not Available
empty
Oaxaca, 68000
MexicoSite Not Available
Tauranga, 3112
New ZealandSite Not Available
empty
Cebu City, 6000
PhilippinesSite Not Available
empty
Manila,
PhilippinesSite Not Available
Pasig City, 1600
PhilippinesSite Not Available
Pasig city, 1605
PhilippinesSite Not Available
empty
Quezon City, 1102
PhilippinesSite Not Available
Quezon City, 1112
PhilippinesSite Not Available
Taguig City, 1102
PhilippinesSite Not Available
Gdansk, 80-214
PolandSite Not Available
Gdynia, 81-519
PolandSite Not Available
empty
Gliwice, 44-101
PolandSite Not Available
Krakow, 30-727
PolandSite Not Available
Lublin, 20-090
PolandSite Not Available
empty
Olsztyn, 10-228
PolandSite Not Available
empty
Vila Nova de Gaia, Porto 4434-502
PortugalSite Not Available
empty
Almada, 2801-951
PortugalSite Not Available
Porto, 4434-502
PortugalSite Not Available
empty
Baia Mare, 430031
RomaniaSite Not Available
Brasov, 500152
RomaniaSite Not Available
empty
Bucharest, 030171
RomaniaSite Not Available
Bucharest, 030171
RomaniaSite Not Available
Bucuresti, 22328
RomaniaSite Not Available
Cluj-Napoca, 400015
RomaniaSite Not Available
Craiova, 200143
RomaniaSite Not Available
empty
Iasi, 700111
RomaniaSite Not Available
Targu Mures, 540136
RomaniaSite Not Available
empty
Targu-Mures, 540136
RomaniaSite Not Available
Chelyabinsk, 454048
Russian FederationSite Not Available
empty
Engels, 413115
Russian FederationSite Not Available
Irkutsk, 664035
Russian FederationSite Not Available
Kazan, 420029
Russian FederationSite Not Available
Kemerovo, 650066
Russian FederationSite Not Available
Kirov, 610027
Russian FederationSite Not Available
empty
Krasnoyarsk, 660133
Russian FederationSite Not Available
empty
Moscow, 129128
Russian FederationSite Not Available
Novosibirsk, 630087
Russian FederationSite Not Available
Omsk, 644013
Russian FederationSite Not Available
empty
Penza, 440071
Russian FederationSite Not Available
empty
Saratov, 410053
Russian FederationSite Not Available
St. Petersburg, 197022
Russian FederationSite Not Available
empty
Tula, 300053
Russian FederationSite Not Available
Volgograd, 400138
Russian FederationSite Not Available
Singapore, 169608
SingaporeSite Not Available
Poprad, 058 01
SlovakiaSite Not Available
George, Eastern Cape 6530
South AfricaSite Not Available
Johannesburg, Gauteng 2013
South AfricaSite Not Available
empty
Pretoria, Gauteng 0044
South AfricaSite Not Available
empty
Saxonwold, Gauteng 2196
South AfricaSite Not Available
empty
L'Hospitalet de Llobregat, Barcelona 08907
SpainSite Not Available
Majadahonda, Madrid 28222
SpainSite Not Available
Barcelona, 08035
SpainSite Not Available
Madrid, 28041
SpainSite Not Available
Málaga, 29010
SpainSite Not Available
Salamanca, 37007
SpainSite Not Available
empty
Valencia, 46009
SpainSite Not Available
empty
Falun, 791 82
SwedenSite Not Available
empty
Uddevalla, 451 80
SwedenSite Not Available
Changhua, 50006
TaiwanSite Not Available
Kaohsiung, 833
TaiwanSite Not Available
Tainan, 704
TaiwanSite Not Available
Taipei, 100
TaiwanSite Not Available
empty
Bangkok, 10330
ThailandSite Not Available
empty
Chiang Mai, 50200
ThailandSite Not Available
Chiang Mai, 50200
ThailandSite Not Available
Chiangmai, 50200
ThailandSite Not Available
empty
Khon Kaen, 40000
ThailandSite Not Available
Pathumthani, 10120
ThailandSite Not Available
Ankara, 6100
TurkeySite Not Available
Istanbul, 34093
TurkeySite Not Available
Izmir, 35100
TurkeySite Not Available
Kayseri, 38039
TurkeySite Not Available
Trabzon, 61080
TurkeySite Not Available
empty
Turkey,
TurkeySite Not Available
Cherkasy, 18009
UkraineSite Not Available
Dnipro, 49102
UkraineSite Not Available
empty
Dnipropetrovsk, 49102
UkraineSite Not Available
empty
Khmel'nytsky, 29000
UkraineSite Not Available
empty
Kiev, 03022
UkraineSite Not Available
Kiev, 03022
UkraineSite Not Available
Kyiv, 03022
UkraineSite Not Available
Lviv, 79044
UkraineSite Not Available
empty
Uzhgorod, 88000
UkraineSite Not Available
Vinnitsa, 21029
UkraineSite Not Available
empty
Zaporizhzhya, 69600
UkraineSite Not Available
empty
Fayetteville, Arkansas 72703
United StatesSite Not Available
empty
Little Rock, Arkansas 72205
United StatesSite Not Available
empty
Rogers, Arkansas 72758
United StatesSite Not Available
empty
Bakersfield, California 93309
United StatesSite Not Available
empty
Long Beach, California 90813
United StatesSite Not Available
West Covina, California 91790
United StatesSite Not Available
empty
Whittier, California 90602
United StatesSite Not Available
empty
Denver, Colorado 80218
United StatesSite Not Available
empty
Hartford, Connecticut 06102-5037
United StatesSite Not Available
empty
Miami, Florida 33176
United StatesSite Not Available
empty
Orange City, Florida 32763
United StatesSite Not Available
empty
Columbus, Georgia 31904
United StatesSite Not Available
empty
Maywood, Illinois 60153
United StatesSite Not Available
Ashland, Kentucky 41101
United StatesSite Not Available
Louisville, Kentucky 40207
United StatesSite Not Available
Bethesda, Maryland 20817
United StatesSite Not Available
empty
Farmington Hills, Michigan 48334
United StatesSite Not Available
empty
Owosso, Michigan 48867
United StatesSite Not Available
Las Vegas, Nevada 89169
United StatesSite Not Available
empty
Basking Ridge, New Jersey 07920
United StatesSite Not Available
empty
Englewood, New Jersey 07361
United StatesSite Not Available
empty
Middletown, New Jersey 07748
United StatesSite Not Available
empty
Montvale, New Jersey 07645
United StatesSite Not Available
empty
Morristown, New Jersey 07962-1956
United StatesSite Not Available
MSK Basking Ridge
New Jersey, New Jersey
United StatesSite Not Available
MSK Bergen
New Jersey, New Jersey
United StatesSite Not Available
MSK Monmoth
New Jersey, New Jersey
United StatesSite Not Available
empty
Commack, New York 11725
United StatesSite Not Available
MSK Westchester
Harrison, New York
United StatesSite Not Available
MSK Commack
Long Island City, New York
United StatesSite Not Available
MSK Rockville Centre
Long Island City, New York
United StatesSite Not Available
New York, New York 10065
United StatesSite Not Available
empty
Rockville Center, New York 11570
United StatesSite Not Available
empty
Uniondale, New York 11553
United StatesSite Not Available
empty
Goldsboro, North Carolina 27534
United StatesSite Not Available
Canton, Ohio 44718
United StatesSite Not Available
empty
Cleveland, Ohio 44106-2602
United StatesSite Not Available
empty
Bend, Oregon 97701
United StatesSite Not Available
empty
Allentown, Pennsylvania 18103
United StatesSite Not Available
empty
Danville, Pennsylvania 17822-2001
United StatesSite Not Available
empty
Watertown, South Dakota 57201
United StatesSite Not Available
empty
San Antonio, Texas 78235
United StatesSite Not Available
Salt Lake City, Utah 84106
United StatesSite Not Available
empty
Olympia, Washington 98506
United StatesSite Not Available
Spokane, Washington 99208-1129
United StatesSite Not Available
Ha Noi, 10000
VietnamSite Not Available
Ho Chi Minh City, 70000
VietnamSite Not Available
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