Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
Sponsor
Pharmacyclics LLC. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02947347
Collaborator
(none)
431
169
4
113
2.6
0
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve subjects with follicular lymphoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
431 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab Versus Placebo in Combination With Rituximab in Treatment Naïve Subjects With Follicular Lymphoma (PERSPECTIVE)
Actual Study Start Date
:
Jan 1, 2017
Anticipated Primary Completion Date
:
Jun 1, 2026
Anticipated Study Completion Date
:
Jun 1, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: (Part 1 : Arm A) ibrutinib + rituximab Subjects will receive 560mg of ibrutinib and rituximab 375mg/m^2 weekly x4 with maintenance. In Part 1, Arm A to Arm B ratio is 3:1 |
Drug: ibrutinib
ibrutinib 560mg administered orally
Other Names:
Drug: rituximab
rituximab 375mg/m^2 IV
|
| Placebo Comparator: (Part 1 : Arm B) placebo + rituximab Subjects will receive placebo and rituximab 375mg/m^2 weekly x4 with maintenance. In Part 1, Arm A to Arm B ratio is 3:1 |
Drug: placebo to match ibrutinib
placebo capsules to match ibrutinib administered orally
Drug: rituximab
rituximab 375mg/m^2 IV
|
| Experimental: (Part 2 : Arm A1) ibrutinib Subjects will receive 560mg of ibrutinib Part 1 Arm A subjects will be re-randomized 1:1 into Part 1 Arm A1 or Arm A2 |
Drug: ibrutinib
ibrutinib 560mg administered orally
Other Names:
|
| Placebo Comparator: (Part 2 : Arm A2) placebo Subjects will receive placebo Part 1 Arm A subjects will be re-randomized 1:1 into Part 2 Arm A1 or Arm A2 |
Drug: placebo to match ibrutinib
placebo capsules to match ibrutinib administered orally
|
Outcome Measures
Primary Outcome Measures
- Progression-free survival [2-5 years]
Secondary Outcome Measures
- Overall Response Rate (ORR) [2-5 years]
Part 1
- Overall Survival [2-5 years]
Part 1
- Infusion-Related Reaction Rate [2-5 years]
Arm A vs. Arm B (Part 1)
- Adverse Events [2-5 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
60 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann Arbor Stage II, III or IV disease.
-
Measurable disease
-
Subjects 70 years of age or older; OR subjects 60-69 years of age who have one or more comorbidities.
-
Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
-
Adequate hematologic function within protocol-defined parameters.
-
Adequate hepatic and renal function within protocol-defined parameters.
-
ECOG performance status score of 0-2.
Exclusion Criteria:
-
Transformed lymphoma
-
Prior treatment for follicular lymphoma
-
Central nervous system lymphoma or leptomeningeal disease
-
Currently active, clinically significant cardiovascular disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Southern Cancer Center | Mobile | Alabama | United States | |
| 2 | Roy and Patricia Disney Family Cancer Center | Burbank | California | United States | |
| 3 | City of Hope | Duarte | California | United States | |
| 4 | Sansum Clinic | Santa Barbara | California | United States | |
| 5 | UCLA Hematology/Oncology | Santa Monica | California | United States | |
| 6 | Helen F. Graham Cancer Center and Research Institute | Newark | Delaware | United States | |
| 7 | SCRI Florida Cancer Specialists South | Fort Myers | Florida | United States | |
| 8 | Florida Cancer Affiliates | Ocala | Florida | United States | |
| 9 | SCRI Florida Cancer Specialists North | Saint Petersburg | Florida | United States | |
| 10 | Rush University Medical Center | Chicago | Illinois | United States | |
| 11 | Ingalls Memorial Hospital | Harvey | Illinois | United States | |
| 12 | Norton Cancer Institute | Louisville | Kentucky | United States | |
| 13 | Tulane Medical Center | New Orleans | Louisiana | United States | |
| 14 | St Joseph Mercy Hospital | Ypsilanti | Michigan | United States | |
| 15 | Goldschmidt Cancer Center | Jefferson City | Missouri | United States | |
| 16 | Southeast Nebraska Cancer Center | Lincoln | Nebraska | United States | |
| 17 | Summit Medical Group | Morristown | New Jersey | United States | |
| 18 | Oncology Hematology Care Inc | Cincinnati | Ohio | United States | |
| 19 | OHSU Knight Cancer Institute Beaverton Clinic | Beaverton | Oregon | United States | |
| 20 | Greenville Health System | Greenville | South Carolina | United States | |
| 21 | SCRI Tennessee Oncology Chattanooga | Chattanooga | Tennessee | United States | |
| 22 | SCRI Tennessee Oncology Nashville | Nashville | Tennessee | United States | |
| 23 | Texas Oncology (Medical City) | Dallas | Texas | United States | |
| 24 | Texas Oncology-Dallas Presbyterian Hospital | Dallas | Texas | United States | |
| 25 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | |
| 26 | SCRI The Center For Cancer and Blood Disorders | Fort Worth | Texas | United States | |
| 27 | MD Anderson Cancer Center | Houston | Texas | United States | |
| 28 | Texas Oncology (Sherman) | Sherman | Texas | United States | |
| 29 | Texas Oncology (Tyler) | Tyler | Texas | United States | |
| 30 | Oncology and Hematology Associates of Southwest Virginia (Blacksburg) | Blacksburg | Virginia | United States | |
| 31 | Swedish Cancer Institute | Seattle | Washington | United States | |
| 32 | Medical Oncology Associates | Spokane | Washington | United States | |
| 33 | W VA University Mary Babb Randolph Cancer Center | Morgantown | West Virginia | United States | |
| 34 | ProHealth Care Cancer Services | Waukesha | Wisconsin | United States | |
| 35 | The Canberra Hospital | Garran | Australian Capital Territory | Australia | |
| 36 | The Townsville Hospital | Douglas | Queensland | Australia | |
| 37 | Mater Misericordiae Health Services | South Brisbane | Queensland | Australia | |
| 38 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | |
| 39 | Royal Hobart Hospital | Hobart | Tasmania | Australia | |
| 40 | Ballarat Health Services | Ballarat | Victoria | Australia | |
| 41 | Monash Medical Centre Clayton Campus | Clayton | Victoria | Australia | |
| 42 | Andrew Love Cancer Center | Geelong | Victoria | Australia | |
| 43 | Fiona Stanley Hospital | Murdoch | Western Australia | Australia | |
| 44 | Kepler Universitätsklinikum | Linz | Oberösterreich | Austria | |
| 45 | Universitätsklinikum Innsbruck | Innsbruck | Tirol | Austria | |
| 46 | Elisabethinen Hospital Linz | Linz | Austria | ||
| 47 | Uniklinikum Salzburg | Salzburg | Austria | ||
| 48 | Cliniques Universitaires Saint-Luc | Bruxelles | Brussels | Belgium | |
| 49 | ZNA Stuivenberg | Antwerpen | Belgium | ||
| 50 | AZ Sint-Jan Brugge Oostende AV | Bruges | Belgium | ||
| 51 | UZ Gent | Gent | Belgium | ||
| 52 | CHU de Liège | Liège | Belgium | ||
| 53 | AZ Nikolaas | Sint-Niklaas | Belgium | ||
| 54 | Gasthuis Zusters Antwerpen | Wilrijk | Belgium | ||
| 55 | Moncton Hospital | Moncton | New Brunswick | Canada | |
| 56 | CIUSSS-de-l'Est-de-l'Île-de-Montréal | Montreal | Quebec | Canada | |
| 57 | CHUM Notre Dame Hospital | Montréal | Quebec | Canada | |
| 58 | Fakultni nemocnice Hradec Kralove | Hradec Kralove | Czechia | ||
| 59 | Fakultni nemocnice Ostrava | Ostrava | Czechia | ||
| 60 | Fakultni nemocnice v Motole | Praha 5 | Czechia | ||
| 61 | Fakultni nemocnice Kralovske Vinohrady | Praha | Czechia | ||
| 62 | Centre Hospitalier de Valence | Valence | Drôme | France | |
| 63 | CHRU de Poitiers La Miletrie | Poitiers | Vienne | France | |
| 64 | Polyclinique Bordeaux Nord Aquitaine | Bordeaux | France | ||
| 65 | CHU de Limoges Hôpital Dupuytren | Limoges | France | ||
| 66 | Centre Hospitalier de Perigueux | Perigueux | France | 24019 | |
| 67 | CHU Bordeaux | Pessac | France | ||
| 68 | Hôpital Civil | Strasbourg | France | ||
| 69 | University General Hospital of Patras | Patras | Achaïa | Greece | |
| 70 | Laiko General Hospital of Athens | Athens | Attiki | Greece | |
| 71 | Theageneio Anticancer Oncology Hospital of Thessaloniki | Thessaloníki | Thessaloniki | Greece | |
| 72 | Attikon University General Hospital | Athens | Greece | ||
| 73 | University General Hospital of Larissa | Larissa | Greece | ||
| 74 | Georgios Papanikolaou General Hospital of Thessaloniki | Thessaloníki | Greece | ||
| 75 | Somogy Megyei Kaposi Mór Oktató Kórház | Kaposvár | Somogy | Hungary | 7400 |
| 76 | Országos Onkológiai Intézet | Budapest | Hungary | ||
| 77 | Debreceni Egyetem Klinikai Kozpont | Debrecen | Hungary | ||
| 78 | Petz Aladár Megyei Oktató Kórház | Gyor | Hungary | ||
| 79 | Bekes Megyei Kozponti Korhaz | Gyula | Hungary | ||
| 80 | Pécsi Tudományegyetem | Pecs | Hungary | ||
| 81 | Barzilai Medical Center | Ashkelon | Israel | ||
| 82 | Hillel Yaffe Medical Center | Hadera | Israel | 38100 | |
| 83 | Bnei Zion Medical Center | Haifa | Israel | ||
| 84 | Lady Davis Carmel Medical Center | Haifa | Israel | ||
| 85 | Rabin Medical Center Beilinson Campus | Petah Tikva | Israel | ||
| 86 | Assuta Medical Center | Tel Aviv | Israel | ||
| 87 | Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | ||
| 88 | Assaf Harofe Medical Center | Zerifin | Israel | ||
| 89 | Ospedale Infermi di Rimini | Rimini | Emilia-Romagna | Italy | |
| 90 | Ospedale Policlinico San Martino | Genova | Liguria | Italy | |
| 91 | Istituto Europeo Di Oncologia | Milan | Lombardia | Italy | |
| 92 | Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino | Piemonte | Italy | |
| 93 | Azienda ospedaliera Universiataria Senese | Siena | Toscana | Italy | |
| 94 | Centro Di Riferimento Oncologico | Aviano | Italy | ||
| 95 | Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi | Bologna | Italy | ||
| 96 | Azienda Sanitaria Ospedaliera S. Croce e Carle | Cuneo | Italy | 12100 | |
| 97 | Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST | Meldola | Italy | 47014 | |
| 98 | ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda | Milano | Italy | ||
| 99 | San Raffaele Scientific Institute | Milan | Italy | ||
| 100 | Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello | Palermo | Italy | 90146 | |
| 101 | Azienda Ospedaliero Universitaria di Parma | Parma | Italy | ||
| 102 | Farmacia Polo Ematologico Policlinico Umberto I | Roma | Italy | ||
| 103 | Policlinico Universitario Campus Biomedico di Roma | Roma | Italy | ||
| 104 | Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino | Italy | ||
| 105 | Gelre Ziekenhuizen | Apeldoorn | Gelderland | Netherlands | |
| 106 | Maasstad Ziekenhuis | Rotterdam | Zuid-Holland | Netherlands | |
| 107 | Leids Universitair Medisch Centrum | Leiden | Netherlands | ||
| 108 | Franciscus Vlietland | Schiedam | Netherlands | ||
| 109 | ETZ-Elisabeth | Tilburg | Netherlands | ||
| 110 | Gelre Ziekenhuizen | Zutphen | Netherlands | ||
| 111 | Palmerston North Hospital | Palmerston North | New Zealand | ||
| 112 | Centrum Onkologii Ziemi Lubelskiej | Lublin | Lubelskie | Poland | |
| 113 | Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii | Gdansk | Pomorskie | Poland | |
| 114 | Szpitale Pomorskie Sp. z o. o. | Gdynia | Pomorskie | Poland | |
| 115 | Malopolskie Centrum Medyczne | Krakow | Poland | ||
| 116 | Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu | Wroclaw | Poland | ||
| 117 | Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im.M.Kopernika | Łódź | Poland | ||
| 118 | Centro Hospitalar Lisboa Norte, E.P.E. Hospital de Santa Maria | Lisboa | Portugal | ||
| 119 | Hospital CUF Descobertas | Lisboa | Portugal | ||
| 120 | Unidade Local de Saúde de Matosinhos SA | Matosinhos | Portugal | ||
| 121 | Centro Hospitalar de São João, E.P.E. | Porto | Portugal | 4200-319 | |
| 122 | Centro Hospitalar do Porto - Hospital de Santo António | Porto | Portugal | ||
| 123 | Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe | Porto | Portugal | ||
| 124 | Regional Clinical Hospital | Krasnoyarsk | Russian Federation | ||
| 125 | City Clinical Hospital n a S P Botkin | Moscow | Russian Federation | ||
| 126 | Russian Oncology Research Center n a N N Blokhin | Moscow | Russian Federation | ||
| 127 | Nizhegorodskaya Regional Clinical Hospital n.a. Semashko | Nizhniy Novgorod | Russian Federation | ||
| 128 | City Hospital #31 | Saint Petersburg | Russian Federation | ||
| 129 | North-West Federal Medical Research Center n.a. V.A. Almazov | Saint Petersburg | Russian Federation | ||
| 130 | Tula Regional Hospital | Tula | Russian Federation | ||
| 131 | Volgograd Regional Clinical Oncology Dispensary | Volgograd | Russian Federation | ||
| 132 | Hospital de Cabueñes | Gijón | Asturias | Spain | |
| 133 | Hospital Universitario Donostia | San Sebastián | Guipúzcoa | Spain | |
| 134 | Hospital Universitario Virgen de Valme | Seville | Sevilla | Spain | |
| 135 | Hospital del Mar | Barcelona | Spain | ||
| 136 | Hospital Universitario Germans Trias i Pujol | Barcelona | Spain | ||
| 137 | Hospital Vall dHebron | Barcelona | Spain | ||
| 138 | ICO L'Hospitalet | Barcelona | Spain | ||
| 139 | Hospital General Universitario Gregorio Maranon | Madrid | Spain | 28007 | |
| 140 | Hospital Universitario HM Sanchinarro - CIOCC | Madrid | Spain | ||
| 141 | Hospital Universitario Infanta Leonor | Madrid | Spain | ||
| 142 | Hospital Universitario La Paz | Madrid | Spain | ||
| 143 | Hospital Arnau de Vilanova | Valencia | Spain | ||
| 144 | Hospital Clinico Universitario de Valladolid | Valladolid | Spain | ||
| 145 | Hospital Quironsalud La Floresta | Zaragoza | Spain | ||
| 146 | Koo Foundation Sun Yat-Sen Cancer Center | Taipei City | Taipei | Taiwan | |
| 147 | Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Taiwan | ||
| 148 | Kaohsiung Medical University Hospital | Kaohsiung | Taiwan | ||
| 149 | Chi Mei Medical Center, Liouying | Liuying | Taiwan | ||
| 150 | National Taiwan University Hospital | Taipei | Taiwan | ||
| 151 | Taipei Veterans General Hospital | Taipei | Taiwan | ||
| 152 | Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi | Fatih | Istanbul | Turkey | |
| 153 | Gazi Universitesi Tip Fakultesi Hastanesi | Ankara | Turkey | ||
| 154 | Ege Universitesi Tip Fakultesi Hastanesi | Bornova | Turkey | ||
| 155 | Mersin Universitesi Tip Fakultesi Hastanesi | Gaziantep | Turkey | ||
| 156 | Dokuz Eylul Universitesi Tip Fakultesi Hastanesi | İzmir | Turkey | ||
| 157 | Erciyes Universitesi Tip Fakultesi Hastanesi | Kayseri | Turkey | ||
| 158 | Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi | Kocaeli | Turkey | ||
| 159 | Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi | Samsun | Turkey | ||
| 160 | Namik Kemal Universitesi Tip Fakultesi Hastanesi | Tekirdağ | Turkey | ||
| 161 | Royal Cornwall Hospital - Hospital Treliske | Tururo | Cornwall | United Kingdom | TR1 3LJ |
| 162 | Norfolk and Norwich University Hospital | Norwich | Norfolk | United Kingdom | |
| 163 | The Royal Marsden NHS Foundation Trust | Sutton | Surrey | United Kingdom | |
| 164 | Addenbrooke's Hospital | Cambridge | United Kingdom | ||
| 165 | Leeds Teaching Hospitals NHS Trust | Leeds | United Kingdom | ||
| 166 | Barts and The London NHS Trust | London | United Kingdom | ||
| 167 | Derriford Hospital | Plymouth | United Kingdom | ||
| 168 | Royal Berkshire Hospital NHS Foundation Trust | Reading | United Kingdom | ||
| 169 | Royal Marsden Hospital - Surrey | Sutton | United Kingdom |
Sponsors and Collaborators
- Pharmacyclics LLC.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Pharmacyclics LLC.
ClinicalTrials.gov Identifier:
NCT02947347
Other Study ID Numbers:
- PCYC-1141-CA
- 2016-003202-14
First Posted:
Oct 27, 2016
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: