Large B-cell Lymphoma Clinical Trial
— GOLSEEK-1Official title:
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP Chemotherapy in Participants With Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1)
The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).
| Status | Recruiting |
| Enrollment | 850 |
| Est. completion date | November 20, 2029 |
| Est. primary completion date | August 14, 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - Histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated large B-cell lymphoma (LBCL) according to 2022 world health organization (WHO) classification including: i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified [including germinal center B-cell (GCB) and activated B-cell (ABC) types] ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements iii) High-grade B-cell lymphoma, not otherwise specified iv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL) v) Epstein-Barr virus + DLBCL - International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) = 1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of = 7 cm OR IPI = 3. - Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification. - Must have Ann Arbor Stage II-IV disease. Exclusion Criteria: - Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study. - Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, FL transformed to a-BCL, Anaplastic lymphoma kinase (ALK) positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphoma. - Documented or suspected central nervous system (CNS) involvement by lymphoma. - Other protocol-defined Inclusion/Exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0112 | Buenos Aires | |
| Argentina | Local Institution - 0113 | Buenos Aires | Ciudad Autónoma De Buenos Aires |
| Argentina | Local Institution - 0136 | Buenos Aires | |
| Argentina | Local Institution - 0421 | Buenos Aires | Ciudad Autónoma De Buenos Aires |
| Argentina | Local Institution - 0119 | Ciudad Autónoma de Buenos Aires | |
| Argentina | Local Institution - 0111 | Córdoba | |
| Australia | Local Institution - 0356 | Birtinya | Queensland |
| Australia | Peninsula Private Hospital | Frankston | Victoria |
| Australia | Local Institution - 0357 | Gosford | New South Wales |
| Australia | Local Institution - 0362 | Heidelberg | Victoria |
| Australia | Local Institution - 0360 | Southport | Queensland |
| Australia | Local Institution - 0359 | St Albans | Victoria |
| Australia | Local Institution - 0361 | Sydney | New South Wales |
| Australia | Local Institution - 0363 | Tiwi | Northern Territory |
| Australia | Local Institution - 0364 | Warrnambool | Victoria |
| Australia | Local Institution - 0358 | Westmead | New South Wales |
| Austria | Local Institution - 0387 | Linz | |
| Austria | Local Institution - 0386 | Vienna | |
| Austria | Local Institution - 0385 | Wels | Oberösterreich |
| Brazil | Local Institution - 0250 | Barretos | São Paulo |
| Brazil | Local Institution - 0246 | Chapecó | Santa Catarina |
| Brazil | Local Institution - 0302 | Curitiba | Paraná |
| Brazil | Local Institution - 0255 | Fortaleza | Ceará |
| Brazil | Local Institution - 0256 | Goiania | Goiás |
| Brazil | Local Institution - 0249 | Jaú | São Paulo |
| Brazil | Local Institution - 0247 | Joinville | Santa Catarina |
| Brazil | Local Institution - 0297 | Lago sul | Distrito Federal |
| Brazil | Local Institution - 0304 | Natal | Rio Grande Do Norte |
| Brazil | Local Institution - 0296 | Niteroi | Rio De Janeiro |
| Brazil | Local Institution - 0253 | Porto Alegre | Rio Grande Do Sul |
| Brazil | Local Institution - 0298 | Rio de Janeiro | |
| Brazil | Local Institution - 0301 | São José do Rio Preto | São Paulo |
| Brazil | Local Institution - 0248 | Sao Paulo | São Paulo |
| Brazil | Local Institution - 0252 | Sao Paulo | São Paulo |
| Brazil | Local Institution - 0316 | Sao Paulo | São Paulo |
| Brazil | Local Institution - 0251 | São Paulo | |
| Brazil | Local Institution - 0294 | São Paulo | |
| Bulgaria | Local Institution - 0393 | Plovdiv | |
| Bulgaria | Local Institution - 0392 | Sofia | |
| Bulgaria | Local Institution - 0394 | Sofia | Sofia (stolitsa) |
| Canada | Local Institution - 0073 | Montreal | Quebec |
| Canada | Local Institution - 0153 | Montreal | Quebec |
| Canada | Local Institution - 0004 | Sherbrooke | Quebec |
| Canada | Local Institution - 0091 | Victoria | British Columbia |
| Chile | Local Institution - 0109 | Chile | Región Metropolitana De Santiago |
| Chile | Clínica Inmunocel | Santiago | Región Metropolitana De Santiago |
| Chile | Local Institution - 0106 | Santiago | Región Metropolitana De Santiago |
| Chile | Local Institution - 0108 | Santiago | Región Metropolitana De Santiago |
| Chile | Local Institution - 0110 | Santiago | Región Metropolitana De Santiago |
| Chile | Local Institution - 0459 | Santiago | Región Metropolitana De Santiago |
| Chile | Local Institution - 0164 | Viña del Mar | Valparaíso |
| China | Local Institution - 0334 | ??? | Liaoning |
| China | Local Institution - 0195 | Beijing | Beijing |
| China | Local Institution - 0291 | Changchun | Jilin |
| China | Local Institution - 0275 | Changsha | Hunan |
| China | Local Institution - 0141 | Cheng Du | Sichuan |
| China | Local Institution - 0196 | Chongqing | Chongqing |
| China | Local Institution - 0236 | Chongqing | Chongqing |
| China | Local Institution - 0274 | Fuzhou | Fujian |
| China | Local Institution - 0133 | Guangzhou | Guangdong |
| China | Local Institution - 0240 | Guangzhou | Guangdong |
| China | Local Institution - 0197 | Hangzhou | Zhejiang |
| China | Local Institution - 0239 | Harbin | Heilongjiang |
| China | Local Institution - 0242 | Jinan | Shandong |
| China | Local Institution - 0344 | Jinan | Shandong |
| China | Local Institution - 0237 | Nanchang | Jiangxi |
| China | Local Institution - 0241 | Nanchang | Jiangxi |
| China | Local Institution - 0338 | Nanning | Guangxi |
| China | Local Institution - 0132 | Shanghai | Shanghai |
| China | Local Institution - 0339 | Shanghai | Shanghai |
| China | Local Institution - 0169 | Shenyang | Liaoning |
| China | Local Institution - 0156 | Suzhou | Jiangsu |
| China | Local Institution - 0234 | Taiyuan | Shanxi |
| China | Local Institution - 0289 | Tianjin | Tianjin |
| China | Local Institution - 0470 | Tianjin | Tianjin |
| China | Local Institution - 0155 | Urumchi | Xinjiang |
| China | Local Institution - 0467 | Urumqi | Xinjiang |
| China | Local Institution - 0457 | Wenzhou | Zhejiang |
| China | Local Institution - 0214 | Wuhan | Hubei |
| China | Local Institution - 0346 | Wuhan | Hubei |
| China | Local Institution - 0157 | Xiamen | Fujian |
| China | Local Institution - 0238 | Zhengzhou | Henan |
| Colombia | Local Institution - 0130 | Bogota | Cundinamarca |
| Colombia | Local Institution - 0129 | Bogotá | Distrito Capital De Bogotá |
| Croatia | Local Institution - 0440 | Osijek | |
| Croatia | Local Institution - 0390 | Zagreb | Grad Zagreb |
| Czechia | Local Institution - 0105 | Brno | Brno-mesto |
| Czechia | Local Institution - 0104 | Hradec Kralove | Hradec Králové |
| Czechia | Local Institution - 0102 | Olomouc | Olomoucký Kraj |
| Czechia | Local Institution - 0120 | Pilsen | Plzenský Kraj |
| Czechia | Local Institution - 0103 | PRague | Praha 10 |
| Czechia | Local Institution - 0243 | Praha 2 | |
| Denmark | Local Institution - 0285 | Aarhus | Midtjylland |
| Denmark | Local Institution - 0284 | Odense | Syddanmark |
| Finland | Local Institution - 0280 | Helsinki | |
| Finland | Local Institution - 0283 | Kuopio | Pohjois-Savo |
| Finland | Local Institution - 0281 | Oulu | Pohjois-Pohjanmaa |
| Finland | Local Institution - 0282 | Turku | Varsinais-Suomi |
| France | Local Institution - 0244 | Bayonne | |
| France | Local Institution - 0090 | Bordeaux | Aquitaine |
| France | Local Institution - 0332 | Brest | Finistère |
| France | Local Institution - 0315 | Caen | |
| France | Local Institution - 0200 | Creteil | Val-de-Marne |
| France | Local Institution - 0292 | Dijon | Côte-d'Or |
| France | Local Institution - 0081 | Lille | Nord |
| France | Local Institution - 0202 | Lille | |
| France | Local Institution - 0087 | Marseille | Bouches-du-Rhône |
| France | Local Institution - 0325 | Nantes | Pays-de-la-Loire |
| France | Local Institution - 0083 | Nice | Alpes-Maritimes |
| France | Local Institution - 0077 | Paris | |
| France | Local Institution - 0324 | Pessac | Aquitaine |
| France | Local Institution - 0089 | Pierre-Bénite | Rhône |
| France | Local Institution - 0306 | Poitiers | Vienne |
| France | Local Institution - 0321 | Saint Priest en Jarez | Loire |
| France | Local Institution - 0335 | Saint-Cloud | Hauts-de-Seine |
| France | Local Institution - 0323 | Saint-Pierre | La Réunion |
| France | Local Institution - 0084 | Strasbourg | Alsace |
| France | Local Institution - 0079 | Tours | Indre-et-Loire |
| France | Local Institution - 0076 | Villejuif | Val-de-Marne |
| Germany | Local Institution - 0383 | Augsburg | Bayern |
| Germany | Local Institution - 0370 | Essen | |
| Germany | Local Institution - 0384 | Koblenz | Rheinland-Pfalz |
| Greece | Local Institution - 0398 | Alexandroupolis | |
| Greece | Local Institution - 0396 | Athens | Attikí |
| Greece | Local Institution - 0399 | Athens | Attikí |
| Greece | Local Institution - 0397 | Chaidari | Attikí |
| Greece | Local Institution - 0395 | Ioannina | Ípeiros |
| Hungary | Local Institution - 0160 | Budapest | Pest |
| Hungary | Local Institution - 0163 | Budapest | |
| Hungary | Local Institution - 0266 | Debrecen | |
| Hungary | Local Institution - 0162 | Kaposvár | Somogy |
| Hungary | Local Institution - 0353 | Nyiregyhaza | Szabolcs-Szatmár-Bereg |
| Hungary | Local Institution - 0161 | Szombathely | Vas |
| India | Local Institution - 0469 | New Delhi | Delhi |
| Japan | Local Institution - 0273 | Amagasaki | Hyogo |
| Japan | Local Institution - 0276 | Anjo | Aichi |
| Japan | Local Institution - 0350 | Bunkyo-ku | Tokyo |
| Japan | Local Institution - 0331 | Chuo | Yamanashi |
| Japan | Local Institution - 0475 | Eiheiji-cho,Yoshida-gun | Fukui |
| Japan | Local Institution - 0313 | Fukuoka | |
| Japan | Local Institution - 0319 | Fukuoka | |
| Japan | Local Institution - 0348 | Fukuoka | |
| Japan | Local Institution - 0269 | Hidaka | Saitama |
| Japan | Local Institution - 0328 | Himeji | Hyogo |
| Japan | Local Institution - 0272 | Hiroshima | |
| Japan | Local Institution - 0170 | Isehara | Kanagawa |
| Japan | Local Institution - 0268 | Itabashiku | Tokyo |
| Japan | Local Institution - 0270 | Kanazawa | Ishikawa |
| Japan | Local Institution - 0168 | Kashiwa | Chiba |
| Japan | Local Institution - 0171 | Kumamoto | |
| Japan | Local Institution - 0215 | Kyoto | |
| Japan | Local Institution - 0343 | Morioka | Iwate |
| Japan | Local Institution - 0288 | Nagaizumi-cho,Sunto-gun | Shizuoka |
| Japan | Local Institution - 0371 | Nagoya | Aichi |
| Japan | Local Institution - 0271 | Ogaki | Gifu |
| Japan | Local Institution - 0329 | Okayama | |
| Japan | Local Institution - 0322 | Osaka | |
| Japan | Local Institution - 0347 | Osaka | |
| Japan | Local Institution - 0166 | Osaka-sayama | Osaka |
| Japan | Local Institution - 0327 | Sapporo | Hokkaido |
| Japan | Local Institution - 0368 | Sapporo | Hokkaido |
| Japan | Local Institution - 0320 | Sendai-shi | Miyagi |
| Japan | Local Institution - 0167 | Yamagata | |
| Japan | Local Institution - 0333 | Yokohama | Kanagawa |
| Korea, Republic of | Kosin University Gospel Hospital | Busan | Pusan-Kwangyokshi |
| Korea, Republic of | Local Institution - 0114 | Busan | Pusan-Kwangyokshi |
| Korea, Republic of | Local Institution - 0115 | Busan | Pusan-Kwangyokshi |
| Korea, Republic of | Local Institution - 0442 | Daegu | Taegu-Kwangyokshi |
| Korea, Republic of | Kyungpook National University Chilgok Hospital | Deagu | Taegu-Kwangyokshi |
| Korea, Republic of | Local Institution - 0116 | Deagu | Taegu-Kwangyokshi |
| Korea, Republic of | Local Institution - 0149 | Goyang-si | Kyonggi-do |
| Korea, Republic of | Local Institution - 0117 | Seongnam | Kyonggi-do |
| Korea, Republic of | Local Institution - 0455 | Seongnam | |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Kyonggi-do |
| Korea, Republic of | Local Institution - 0068 | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Local Institution - 0069 | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Local Institution - 0070 | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Local Institution - 0100 | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Local Institution - 0118 | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Local Institution - 0143 | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Local Institution - 0233 | Suwon-si | Kyonggi-do |
| Malaysia | Local Institution - 0432 | George Town | Pulau Pinang |
| Malaysia | Local Institution - 0431 | Kuching | Sarawak |
| Mexico | Local Institution - 0126 | Cdmx | Distrito Federal |
| Mexico | Local Institution - 0122 | Ciudad de México | Distrito Federal |
| Mexico | Local Institution - 0444 | Hermosillo | Sonora |
| Mexico | Local Institution - 0463 | Hermosillo | Sonora |
| Mexico | Local Institution - 0123 | Huixquilucan | |
| Mexico | Local Institution - 0128 | México | Distrito Federal |
| Mexico | Local Institution - 0121 | Mexico City | Distrito Federal |
| Mexico | Local Institution - 0139 | Monterrey | Nuevo León |
| Mexico | Local Institution - 0127 | Morelia | Michoacán |
| Mexico | Local Institution - 0125 | Oaxaca de Juarez | Oaxaca |
| Mexico | Local Institution - 0124 | Puebla | |
| New Zealand | Local Institution - 0462 | Auckland | |
| New Zealand | Local Institution - 0367 | Dunedin | Otago |
| New Zealand | Local Institution - 0366 | Hamilton | Waikato |
| Norway | Local Institution - 0391 | Oslo | |
| Poland | Local Institution - 0336 | Bydgoszcz | Kujawsko-pomorskie |
| Poland | Local Institution - 0330 | Katowice | Slaskie |
| Poland | Local Institution - 0201 | Kraków | Malopolskie |
| Poland | Local Institution - 0337 | Lublin | Lubelskie |
| Poland | Local Institution - 0388 | Poznan | Wielkopolskie |
| Poland | Local Institution - 0443 | Warszawa | Mazowieckie |
| Portugal | Local Institution - 0286 | Lisboa | |
| Portugal | Local Institution - 0098 | Porto | |
| Puerto Rico | Local Institution - 0372 | San Juan | |
| Romania | Local Institution - 0380 | Brasov | |
| Romania | Local Institution - 0374 | Bucure?ti | |
| Romania | Local Institution - 0377 | Bucure?ti | |
| Romania | Local Institution - 0378 | Bucure?ti | |
| Romania | Local Institution - 0382 | Bucure?ti | |
| Romania | Local Institution - 0375 | Bucuresti | Bucure?ti |
| Romania | Local Institution - 0381 | Bucuresti | Bucure?ti |
| Romania | Local Institution - 0423 | Cluj | |
| Romania | Local Institution - 0379 | Ia?i | |
| Romania | Local Institution - 0376 | Sibiu | |
| Romania | Local Institution - 0417 | Tg.Mures | Mure? |
| Saudi Arabia | Local Institution - 0439 | Dammam | Ash Sharqiyah |
| Saudi Arabia | Local Institution - 0416 | Riyadh | |
| Singapore | Local Institution - 0427 | Singapore | Central Singapore |
| Slovakia | Local Institution - 0355 | Banska Bystrica | Banskobystrický Kraj |
| Slovakia | Local Institution - 0204 | Bratislava | |
| Spain | Local Institution - 0412 | A Coruña | A Coruña [La Coruña] |
| Spain | Local Institution - 0389 | Barakaldo | Bizkaia |
| Spain | Local Institution - 0095 | Cáceres | |
| Spain | Local Institution - 0409 | El Palmar, Murcia | Murcia, Región De |
| Spain | Local Institution - 0071 | L'Hospitalet Del Llobregat | Barcelona [Barcelona] |
| Spain | Local Institution - 0072 | Madrid | |
| Spain | Local Institution - 0096 | Majadahonda | Madrid, Comunidad De |
| Spain | Local Institution - 0092 | Malaga | Málaga |
| Spain | Local Institution - 0093 | Salamanca | |
| Spain | Local Institution - 0314 | San Sebastian | Gipuzkoa |
| Spain | Local Institution - 0172 | Santa Cruz de Tenerife | Canarias |
| Sweden | Local Institution - 0278 | Linköping | Östergötlands Län [se-05] |
| Sweden | Local Institution - 0277 | Uppsala | Uppsala Län [se-03] |
| Taiwan | Local Institution - 0142 | Chiayi City | Chiayi |
| Taiwan | Local Institution - 0159 | Kaohsiung | |
| Taiwan | Local Institution - 0135 | Taichung | |
| Taiwan | Local Institution - 0145 | Taichung | |
| Taiwan | Local Institution - 0146 | Tainan City | Tainan |
| Taiwan | Local Institution - 0134 | Taipei | |
| Taiwan | Local Institution - 0147 | Taipei | |
| Taiwan | Local Institution - 0158 | Taoyuan | |
| Thailand | Local Institution - 0426 | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Local Institution - 0434 | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Local Institution - 0473 | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Local Institution - 0428 | Chiang Mai | |
| Turkey | Local Institution - 0400 | Ankara | |
| Turkey | Local Institution - 0401 | Ankara | |
| Turkey | Local Institution - 0405 | Ankara | |
| Turkey | Local Institution - 0422 | Ankara | |
| Turkey | Local Institution - 0406 | Izmir | |
| Turkey | Local Institution - 0403 | Mersin | |
| Turkey | Local Institution - 0407 | Samsun | |
| Turkey | Local Institution - 0402 | Trabzon | |
| United States | Local Institution - 0303 | Atlanta | Georgia |
| United States | Local Institution - 0408 | Baton Rouge | Louisiana |
| United States | Local Institution - 0190 | Buffalo | New York |
| United States | Local Institution - 0174 | Chapel Hill | North Carolina |
| United States | Local Institution - 0182 | Chicago | Illinois |
| United States | Local Institution - 0461 | Des Moines | Iowa |
| United States | Local Institution - 0436 | Edgewood | Kentucky |
| United States | Local Institution - 0031 | Fairway | Kansas |
| United States | Local Institution - 0435 | Fort Sam Houston | Texas |
| United States | Local Institution - 0046 | Houston | Texas |
| United States | Local Institution - 0424 | Houston | Texas |
| United States | Mayo Clinic in Florida | Jacksonville | Florida |
| United States | Local Institution - 0437 | Kansas City | Missouri |
| United States | D&H Cancer Research Center LLC | Margate | Florida |
| United States | Local Institution - 0066 | Massillon | Ohio |
| United States | Local Institution - 0067 | Minneapolis | Minnesota |
| United States | Local Institution - 0014 | Mobile | Alabama |
| United States | Local Institution - 0049 | Morristown | New Jersey |
| United States | Local Institution - 0175 | New Brunswick | New Jersey |
| United States | Local Institution - 0176 | New York | New York |
| United States | Local Institution - 0369 | New York | New York |
| United States | Local Institution - 0012 | Pensacola | Florida |
| United States | Mayo Clinic in Arizona - Phoenix | Phoenix | Arizona |
| United States | Local Institution - 0009 | Pittsburgh | Pennsylvania |
| United States | Local Institution - 0179 | Portland | Oregon |
| United States | Local Institution - 0466 | Reno | Nevada |
| United States | Local Institution - 0293 | Richmond | Virginia |
| United States | Mayo Clinic in Rochester, Minnesota | Rochester | Minnesota |
| United States | Local Institution - 0342 | San Francisco | California |
| United States | Local Institution - 0048 | Skokie | Illinois |
| United States | Local Institution - 0414 | Tampa | Florida |
| United States | Local Institution - 0450 | Tulsa | Oklahoma |
| United States | Local Institution - 0419 | York | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, India, Japan, Korea, Republic of, Malaysia, Mexico, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free survival (PFS) assessed by the Investigator | Up to approximately 67 months | ||
| Secondary | Overall survival (OS) | Up to approximately 67 months | ||
| Secondary | Event-free survival (EFS) | Up to approximately 67 months | ||
| Secondary | Complete Metabolic Response assessed by the Independent Response Adjudication Committee (IRAC) | Up to approximately 18 weeks | ||
| Secondary | Minimal residual disease (MRD) negativity rate | Up to approximately 18 weeks | ||
| Secondary | Progression-free survival (PFS) assessed by the IRAC | Up to approximately 47 months | ||
| Secondary | Objective response (OR) assessed by the Investigator | Up to approximately 18 weeks | ||
| Secondary | Complete metabolic response (CMR) assessed by the Investigator | Up to approximately 18 weeks | ||
| Secondary | PFS24 assessed by the Investigator 24 months after randomization | Up to 24 months | ||
| Secondary | Duration of response (DoR) | Up to approximately 67 months | ||
| Secondary | Second progression-free survival (PFS2) assessed by the Investigator | Up to approximately 67 months | ||
| Secondary | Relative dose intensity (%) | Up to 18 weeks | ||
| Secondary | Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) Questionnaire | Up to approximately 67 months | ||
| Secondary | Time from randomization to meaningful improvement in primary domains of interest in the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS) Questionnaire | Up to approximately 67 months | ||
| Secondary | Mean change from baseline in the EORTC QLQ-C30 | Up to approximately 67 months | ||
| Secondary | Mean change from baseline in the FACT-LymS | Up to approximately 67 months | ||
| Secondary | Number of participants with Adverse Events (AEs) | Up to approximately 20 weeks | ||
| Secondary | Number of participants with treatment-emergent adverse events (TEAEs) | Up to approximately 20 weeks | ||
| Secondary | Number of participants with laboratory abnormalities | Up to approximately 20 weeks | ||
| Secondary | Number of participants with vital sign abnormalities | Up to approximately 20 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
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