AzTrials
AzTrials

Diffuse Large B-cell LymphomaPhase 3PILLAR2NCT00790036

Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy

A Phase 3 study testing Everolimus in people with Diffuse Large B-cell Lymphoma, run by Novartis Pharmaceuticals at 202 sites in 34 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients had achieved complete response with first-line rituximab-chemotherapy Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-cell Lymphoma
What is being tested?
Everolimus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
742 participants
Where
202 sitesin 34 countries
Study dates
24 Jul 2009to 15 Jun 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with previous histologically confirmed Stage III-IV (or Stage II bulky disease, defined as any tumor mass more than 10 cm in longest diameter), at time of original diagnosis, diffuse large B cell lymphoma (pathology report based on original tumor tissue/lymph node is acceptable for meeting inclusion criteria, but tumor tissue (slides/block) must be available to be sent for central pathology to confirm diagnosis).
  • Patients defined as poor risk with IPI of 3, 4, or 5 at time of original diagnosis.
  • Patients age ≥ 18 years old.
  • Patients must have achieved complete remission (CR) based on the revised IWRC (Cheson et al 2007) following first line R-chemotherapy treatment. Radiation therapy (RT) during or after R-chemotherapy is acceptable provided: 1) it ends 4 weeks prior to start of study drug and, 2) in case of consolidation RT targeted at initial bulky tumor mass, administered after R-chemotherapy, patient is already in CR before initiating RT. Complete remission from R-chemotherapy must be confirmed by clinical and radiologic evaluation along with bone marrow confirmation (if bone marrow was involved by lymphoma before the R-chemotherapy treatment). Local pathology report on the bone marrow biopsy is acceptable. If bone marrow was not involved by lymphoma before R-chemotherapy treatment, then bone marrow confirmation after R-chemotherapy is not required.
  • Patients who received a minimum 5 cycles of R-chemotherapy treatment and maximum 8 cycles of R-chemotherapy treatment. Any variation of CHOP (R-CHOP-14, R-CHOP-21) is acceptable. Liposomal doxorubicin, epirubicin, or pirarubicin (also known as therarubicin) is acceptable. R-EPOCH is acceptable.
  • Patients' last treatment with R-chemotherapy must be 6 to 14 weeks prior to start of study drug.
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  • Patients with ECOG performance status (PS) 0, 1, or 2.
  • Patients willing to provide a portion of his/her tumor tissue from original diagnosis or lymph node to confirm diagnosis.
  • The following laboratory values obtained ≤ 21 days prior to start of study drug:
  • Absolute neutrophil count ≥ 1000/mm3 (or 1.0 GI/L, SI units)
  • Platelet count ≥ 100,000/mm3 (or 100 GI/L, SI units)
  • Hemoglobin ≥ 9 g/dL (can be achieved by transfusion)
  • Total bilirubin ≤ 2 x ULN (if >2 x ULN direct bilirubin is required and should be ≤1.5 x ULN)
  • AST ≤ 3 x ULN
  • Serum creatinine ≤ 2 x ULN
  • Women of childbearing potential must have had a negative serum pregnancy test 14 days prior to the start of study drug plus a negative local urine pregnancy test on Day 1, Cycle 1 prior to treatment and must be willing to use adequate methods of contraception during the study and for 8 weeks after study drug administration.
  • Patients who give a written informed consent obtained according to local guidelines.
  • Patients capable of swallowing intact study medication tablets and following directions regarding taking study drug, or have a daily caregiver who will be responsible for administering study drug.

Who cannot join

  • Patients with evidence of disease according to the revised IWRC (Cheson et al 2007) after completion of the first-line R-chemotherapy treatment, prior to study entry.
  • Patients receiving ongoing radiation therapy or who received radiation therapy to the residual tumor masses < 4 weeks from start of study drug.
  • Patients who have previously received systemic mTOR inhibitor (sirolimus, temsirolimus, everolimus, etc).
  • Patients with evidence of current central nervous system (CNS) involvement with lymphoma. Patients who have only had prophylactic intrathecal chemotherapy against CNS disease are eligible.
  • Patients with transformed follicular lymphoma.
  • Patients who received ibritumomab tiuxetan (Zevalin®), in order to avoid potential delayed kidney toxicities.
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  • Patients who had myelosuppressive chemotherapy or biologic therapy < 3 weeks from start of study drug.
  • Patients receiving chronic systemic immunosuppressive agents. Inhaled and topical steroids are acceptable. Patients may be receiving stable (not increased within the last month) chronic doses of corticosteroids with a maximum dose of 20 mg of prednisone or ≤5 mg of dexamethasone per day, if they are being given for disorders other than lymphoma such as rheumatoid arthritis, polymyalgia rheumatica, adrenal insufficiency or asthma.
  • Patients with active, bleeding diathesis.
  • Patients with a known history of HIV seropositivity.
  • Patients with known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to any of the excipients.
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
  • unstable angina pectoris, symptomatic congestive heart failure (NYHA II, III, IV), myocardial infarction ≤ 6 months prior to first study drug, serious uncontrolled cardiac arrhythmia, cerebrovascular accidents ≤ 6 months before study drug start
  • severely impaired lung function as defined as spirometry and DLCO that is ≤ 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
  • poorly controlled diabetes as defined by fasting serum glucose >2.0 x ULN
  • any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study
  • nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by this study drug, such as severe hypertension that is not controlled with medical management and thyroid abnormalities whose thyroid function cannot be maintained in the normal range by medication
  • liver disease such as cirrhosis or decompensated liver disease.
  • Patients who have a history of another primary malignancy ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of uterine cervix.
  • Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes.
  • Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study drug start.
  • Patients unwilling to or unable to comply with the protocol.

Trial locations and contacts

202 sites in 34 countries.

202 sites in 34 countries

United States34 sites

  • University Cancer & Blood Center, LLC

    Athens, Georgia, 30607

  • University Cancer Institute

    Boynton Beach, Florida, 33426

  • Lahey Clinic Dept of Lahey Clinic (3)

    Burlington, Massachusetts, 01805

  • University of Vermont Office of Clinical Trials Res.

    Burlington, Vermont, 05404

  • Ironwood Cancer and Research Centers SC

    Chandler, Arizona, 85224

  • Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2)

    Charleston, South Carolina, 29425

  • Levine Cancer Institute Oncology

    Charlotte, North Carolina, 28203

  • University of Virginia Health Systems SC-2

    Charlottesville, Virginia, 22908-0334

  • Rush University Medical Center Div. of Hematology & Oncology

    Chicago, Illinois, 60612

  • University of Colorado Health

    Colorado Springs, Colorado, 80909

  • Columbus Regional

    Columbus, Georgia, 31904

  • Denver Health & Hospital Authority CACZ885M2301

    Denver, Colorado, 80204-4507

  • Highlands Oncology Group Dept of Highlands Oncology Grp

    Fayetteville, Arkansas, 72703

  • The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD

    Fort Worth, Texas, 76104

  • Cancer Centers of the Carolinas Cancer Centers of Carolinas (3

    Greenville, South Carolina, 29605

  • Rocky Mountain Cancer Centers RMCC

    Greenwood Village, Colorado

  • University of Texas/MD Anderson Cancer Center Dept of MD Anderson (18)

    Houston, Texas, 77030-4009

  • Baylor College of Medicine Dept.of Baylor College of Med.

    Houston, Texas, 77030

  • Indiana University Hospital IU Cancer Center

    Indianapolis, Indiana, 46202

  • University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (3)

    La Jolla, California, 92093-0658

  • Dartmouth Hitchcock Medical Center Dartmouth

    Lebanon, New Hampshire, 03756

  • USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisMedicalCenter(4)

    Los Angeles, California, 90033

  • Dean Health System

    Madison, Wisconsin, 53717

  • University of Tennessee Cancer Institute SC-2

    Memphis, Tennessee, 38104

  • The West Clinic

    Memphis, Tennessee, 38120

  • Tulane University Health Sciences Center Office of Clinical Research

    New Orleans, Louisiana, 70112

  • University of Pittsburgh Medical Center SC-3

    Pittsburgh, Pennsylvania, 15213

  • Blue Ridge Research Center at Roanoke Neurological Center SC

    Roanoke, Virginia, 24018

  • Mayo Clinic - Rochester Dept. of MayoClinic-Rochester

    Rochester, Minnesota, 55905

  • South Texas Oncology and Hematology, PA South Texas Oncology (2)

    San Antonio, Texas, 78258

  • Washington University School of Medicine Div. of Medical Oncology

    St Louis, Missouri, 63110

  • Texas A&M HealthSciencesCtr-Scott & White Memorial Hospital CenterForCancerPrevention&Care

    Temple, Texas, 76508

  • Waukesha Memorial Hospital Cancer Center Dept.ofWaukeshaMemorialHosp.

    Waukesha, Wisconsin, 53188

  • Wake Forest University Baptist Medical Center Dept. of WFUHS

    Winston-Salem, North Carolina, 27157

Other trials in United States

Italy18 sites

  • Novartis Investigative Site

    Brindisi, BR, 72100

  • Novartis Investigative Site

    Catania, CT, 95124

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Lecce, LE, 73100

  • Novartis Investigative Site

    Milan, MI, 20141

  • Novartis Investigative Site

    Modena, MO, 41100

  • Novartis Investigative Site

    Palermo, PA, 90146

  • Novartis Investigative Site

    Pescara, PE, 65124

  • Novartis Investigative Site

    Piacenza, PC, 29100

  • Novartis Investigative Site

    Pisa, PI, 56126

  • Novartis Investigative Site

    Potenza, PZ, 85100

  • Novartis Investigative Site

    Reggio Calabria, RC, 89124

  • Novartis Investigative Site

    Reggio Emilia, RE, 42123

  • Novartis Investigative Site

    Rozzano, MI, 20089

  • Novartis Investigative Site

    San Giovanni Rotondo, FG, 71013

  • Novartis Investigative Site

    Siena, SI, 53100

  • Novartis Investigative Site

    Venezia, VE, 30174

Other trials in Italy

Japan14 sites

  • Novartis Investigative Site

    Chuo-ku, Tokyo, 104-0045

  • Novartis Investigative Site

    Fukuoka, 811-1395

  • Novartis Investigative Site

    Kanazawa, Ishikawa-ken, 920-8641

  • Novartis Investigative Site

    Kashiwa, Chiba, 277-8577

  • Novartis Investigative Site

    Koto, Tokyo, 135-8550

  • Novartis Investigative Site

    Kure, Hiroshima, 737-0023

  • Novartis Investigative Site

    Kyoto, Kyoto, 602-8566

  • Novartis Investigative Site

    Matsuyama, Ehime, 790-8524

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 466-8650

  • Novartis Investigative Site

    Osaka, Osaka, 545-8586

  • Novartis Investigative Site

    Sendai, Miyagi, 980-8574

  • Novartis Investigative Site

    Shinjuku-ku, Japan, 160-0023

  • Novartis Investigative Site

    Suita, Osaka, 565-0871

  • Novartis Investigative Site

    Sunto-gun, Shizuoka, 411-8777

Other trials in Japan

Spain14 sites

  • Novartis Investigative Site

    Badalona, Catalonia, 08916

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, Catalonia, 08028

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Cadiz, Andalusia, 11009

  • Novartis Investigative Site

    Donostia / San Sebastian, Basque Country, 20080

  • Novartis Investigative Site

    Madrid, 28006

  • Novartis Investigative Site

    Majadahonda, Madrid, 28222

  • Novartis Investigative Site

    Pamplona, Navarre, 31008

  • Novartis Investigative Site

    Pozuelo de Alarcón, Madrid, 28223

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208

  • Novartis Investigative Site

    Santander, Cantabria, 39008

  • Novartis Investigative Site

    Seville, Andalusia, 41013

  • Novartis Investigative Site

    Valencia, Valencia, 46010

Other trials in Spain

Canada10 sites

  • Novartis Investigative Site

    Brampton, Ontario, L6R 3J7

  • Novartis Investigative Site

    Cambridge, Ontario, N1R 3G2

  • Novartis Investigative Site

    Greenfield Park, Quebec, J4V 2H1

  • Novartis Investigative Site

    Mississauga, Ontario, L5M 2V8

  • Novartis Investigative Site

    Montreal, Quebec, H1T 2M4

  • Novartis Investigative Site

    Montreal, Quebec, H4A 3J1

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6

  • Novartis Investigative Site

    Québec, Quebec, G1J 1Z4

  • Novartis Investigative Site

    Toronto, Ontario, M4C 3E7

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Germany8 sites

  • Novartis Investigative Site

    Aachen, 52074

  • Novartis Investigative Site

    Bad Saarow, 15526

  • Novartis Investigative Site

    Bamberg, 96049

  • Novartis Investigative Site

    Cologne, 51067

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106

  • Novartis Investigative Site

    Hamburg, 20095

  • Novartis Investigative Site

    München, 81737

Other trials in Germany

Russia8 sites

  • Novartis Investigative Site

    Moscow, 115478

  • Novartis Investigative Site

    Moscow, 125167

  • Novartis Investigative Site

    Moscow, 129110

  • Novartis Investigative Site

    Nizhny Novgorod, 603000

  • Novartis Investigative Site

    Petrozavodsk, 185019

  • Novartis Investigative Site

    Saint Petersburg, 191024

  • Novartis Investigative Site

    Saint Petersburg, 197341

  • Novartis Investigative Site

    Saint Petersburg, 197758

Other trials in Russia

China6 sites

  • Novartis Investigative Site

    Beijing, 100021

  • Novartis Investigative Site

    Beijing, 100036

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Guangzhou, 510060

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310003

  • Novartis Investigative Site

    Shanghai, 200025

Other trials in China

France6 sites

  • Novartis Investigative Site

    Amiens Cedex1, 80054

  • Novartis Investigative Site

    Brest, 29200

  • Novartis Investigative Site

    La Roche-sur-Yon, 85925

  • Novartis Investigative Site

    Limoges, 87042

  • Novartis Investigative Site

    Pessac, 33604

  • Novartis Investigative Site

    Saint-Priest-en-Jarez, 42271

Other trials in France

Austria5 sites

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020

  • Novartis Investigative Site

    Leoben, A-8700

  • Novartis Investigative Site

    Linz, 4010

  • Novartis Investigative Site

    Vienna, 1090

  • Novartis Investigative Site

    Vienna, 1140

Other trials in Austria

Brazil5 sites

  • Novartis Investigative Site

    Campinas, São Paulo, 13083-970

  • Novartis Investigative Site

    Curitiba, Paraná, 80060-900

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Novartis Investigative Site

    São Paulo, São Paulo, 01224-000

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Egypt5 sites

  • Novartis Investigative Site

    Al Mansurah, 35516

  • Novartis Investigative Site

    Alexandria

  • Novartis Investigative Site

    Cairo, 11566

  • Novartis Investigative Site

    Cairo, 12655

  • Novartis Investigative Site

    Cairo

Other trials in Egypt

Hungary5 sites

  • Novartis Investigative Site

    Budapest, 1122

  • Novartis Investigative Site

    Győr, H-9023

  • Novartis Investigative Site

    Kaposvár, 7400

  • Novartis Investigative Site

    Pécs, 7624

  • Novartis Investigative Site

    Szeged, H-6725

Other trials in Hungary

Israel5 sites

  • Novartis Investigative Site

    Haifa, 3525408

  • Novartis Investigative Site

    Jerusalem, 91120

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Ramat Gan, 5266202

  • Novartis Investigative Site

    Tel Aviv, 64239

Other trials in Israel

Lebanon5 sites

  • Novartis Investigative Site

    Beirut, 1107 2020

  • Novartis Investigative Site

    Beirut, 166378

  • Novartis Investigative Site

    Beirut, 166830

  • Novartis Investigative Site

    Beirut, 6301

  • Novartis Investigative Site

    Saida, 652

Other trials in Lebanon

Turkey (Türkiye)5 sites

  • Novartis Investigative Site

    Ankara, 06100

  • Novartis Investigative Site

    Ankara, 06460

  • Novartis Investigative Site

    Antalya, 07070

  • Novartis Investigative Site

    Istanbul, 34093

  • Novartis Investigative Site

    Talas / Kayseri, 38039

Other trials in Turkey (Türkiye)

Australia4 sites

  • Novartis Investigative Site

    Clayton, Victoria, 3168

  • Novartis Investigative Site

    Douglas, Queensland, 4810

  • Novartis Investigative Site

    Geelong, Victoria, 3220

  • Novartis Investigative Site

    Greenslopes, Queensland, 4120

Other trials in Australia

Czechia4 sites

  • Novartis Investigative Site

    Brno-Bohunice, Czech Republic, 625 00

  • Novartis Investigative Site

    Hradec Králové, CZE, 500 05

  • Novartis Investigative Site

    Olomouc, CZE, 775 20

  • Novartis Investigative Site

    Prague, 100 34

Other trials in Czechia

Greece4 sites

  • Novartis Investigative Site

    Athens, GR, 115 27

  • Novartis Investigative Site

    Athens, 11527

  • Novartis Investigative Site

    Heraklion Crete, Greece, 711 10

  • Novartis Investigative Site

    Ioannina, GR, 455 00

Other trials in Greece

Poland4 sites

  • Novartis Investigative Site

    Bydgoszcz, 85-796

  • Novartis Investigative Site

    Lodz, 93-509

  • Novartis Investigative Site

    Lublin, Lublin Voivodeship, 20-080

  • Novartis Investigative Site

    Warsaw, 02-106

Other trials in Poland

South Korea4 sites

  • Novartis Investigative Site

    Gyeonggi-do, Korea, 10408

  • Novartis Investigative Site

    Seoul, Korea, 03722

  • Novartis Investigative Site

    Seoul, Korea, 05505

  • Novartis Investigative Site

    Seoul, Korea, 06351

Other trials in South Korea

Thailand4 sites

  • Novartis Investigative Site

    Bangkok, 10330

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Bangkok, 10700

  • Novartis Investigative Site

    Songkhla, 90110

Other trials in Thailand

Argentina3 sites

  • Novartis Investigative Site

    Buenos Aires, C1114AAN

  • Novartis Investigative Site

    Córdoba, X5016KEH

  • Novartis Investigative Site

    La Plata, Buenos Aires, B1900AWT

Other trials in Argentina

Colombia3 sites

  • Novartis Investigative Site

    Bogotá, Cundinamarca

  • Novartis Investigative Site

    Bucaramanga

  • Novartis Investigative Site

    Medellín

Other trials in Colombia

Saudi Arabia3 sites

  • Novartis Investigative Site

    Dammam, 15215

  • Novartis Investigative Site

    Jeddah, 21423

  • Novartis Investigative Site

    Riyadh, 11426

Other trials in Saudi Arabia

Singapore3 sites

  • Novartis Investigative Site

    Singapore, 119228

  • Novartis Investigative Site

    Singapore, 169608

  • Novartis Investigative Site

    Singapore, 169610

Other trials in Singapore

Mexico2 sites

  • Novartis Investigative Site

    Mexico City, Mexico City, 01120

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64020

Other trials in Mexico

New Zealand2 sites

  • Novartis Investigative Site

    Grafton, Auckland

  • Novartis Investigative Site

    Wellington

Other trials in New Zealand

Peru2 sites

  • Novartis Investigative Site

    Jesus Maria, Lima region, 11

  • Novartis Investigative Site

    San Isidro, Lima region, 27

Other trials in Peru

Switzerland2 sites

  • Novartis Investigative Site

    Bellinzona, 6500

  • Novartis Investigative Site

    Zurich, CH, 8091

Other trials in Switzerland

Venezuela2 sites

  • Novartis Investigative Site

    Caracas, Distrito Federal, 1010

  • Novartis Investigative Site

    Caracas, Distrito Federal, 1011

Other trials in Venezuela

Hong Kong1 site

  • Novartis Investigative Site

    Hong Kong

Other trials in Hong Kong

Norway1 site

  • Novartis Investigative Site

    Oslo, NO-0424

Other trials in Norway

Slovakia1 site

  • Novartis Investigative Site

    Bratislava, 833 10

Other trials in Slovakia

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy

Phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients had achieved complete response with first-line rituximab-chemotherapy

Being tested
Everolimus, Everolimus Placebo
Keywords
Diffuse large B cell lymphoma, DLBCL, poor risk, R-IPI 3-5, adjuvant therapy, after R-CHOP or R-EPOCH, after R-CHOP, B-cell lymphoma, lymphoma, b cells, blood cancer, lymph nodes, Hodgkin's, non-Hodgkin
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, B-Cell, Lymphoma, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EverolimusDrug

    Also called RAD001

    Everolimus was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.

  • Everolimus PlaceboDrug

    Everolimus placebo was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.

Study groups in NCT00790036
Study groupRoleWhat they receive
EverolimusExperimentalParticipants who received Everolimus 10 mg (two 5 mg tablets), daily for 12 months
Receives: Drug: Everolimus
PlaceboPlacebo comparatorParticipants who received Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
Receives: Drug: Everolimus Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free Survival (DFS)

    DFS was defined as the time from date of randomization to the date of event defined as the first documented relapse of the disease or death due to any cause. Relapse was based on investigator assessment and was assigned only if: It was documented according to Cheson guidelines by an objective radiological assessment method; It was documented by a biopsy proven lymphoma including new or recurrent bone marrow involvement; A new anticancer therapy for lymphoma started with subsequent confirmation of the relapse within 4 weeks of the start of this anticancer therapy

    Measured: From date of randomization to the date of event defined as the first documented recurrence of the disease, or death due to any cause and up to 6 years

Secondary outcomes (2)

  1. Overall Survival (OS)

    OS was defined as the time from date of randomization to date of death due to any cause. If the patient was not known to have died, survival was censored at the date of the last contact.

    Measured: From date of randomization to date of death due to any cause up to around 7 years

  2. Lymphoma-specific Survival (LSS)

    LSS was defined as time from randomization to death as a result of lymphoma.

    Measured: From randomization to death documented as a result of lymphoma up to 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2008 (estimated)
  2. Study start24 Jul 2009
  3. Primary completion15 Jun 2016
  4. Study completion15 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
742 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00790036
Sponsor's protocol ID
CRAD001N2301
Other IDs
2008-000498-40, 2008
Acronym
PILLAR2
Status last verified
Jun 2017
First submitted
11 Nov 2008
Last updated
12 Jul 2017
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Witzig TE, Tobinai K, Rigacci L, Ikeda T, Vanazzi A, Hino M, Shi Y, Mayer J, Costa LJ, Bermudez Silva CD, Zhu J, Belada D, Bouabdallah K, Kattan JG, Kuruvilla J, Kim WS, Larouche JF, Ogura M, Ozcan M, Fayad L, Wu C, Fan J, Louveau AL, Voi M, Cavalli F. Adjuvant everolimus in high-risk diffuse large B-cell lymphoma: final results from the PILLAR-2 randomized phase III trial. Ann Oncol. 2018 Mar 1;29(3):707-714. doi: 10.1093/annonc/mdx764.

    PubMed 29253068

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Everolimus in people with Diffuse Large B-cell Lymphoma, run by Novartis Pharmaceuticals at 202 sites in 34 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 202 sites in United States, Italy, Japan, Spain, Canada and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (DFS) (time frame: From date of randomization to the date of event defined as the first documented recurrence of the disease, or death due to any cause and up to 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00790036, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.

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