Clinical trial NCT00790036: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diffuse Large B-cell Lymphoma
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
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 742
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: Inclusion Criteria:

1. 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).
2. Patients defined as poor risk with IPI of 3, 4, or 5 at time of original diagnosis.
3. Patients age ≥ 18 years old.
4. 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.
5. 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.
6. Patients' last treatment with R-chemotherapy must be 6 to 14 weeks prior to start of study drug.
7. Patients with ECOG performance status (PS) 0, 1, or 2.
8. Patients willing to provide a portion of his/her tumor tissue from original diagnosis or lymph node to confirm diagnosis.
9. 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
10. 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.
11. Patients who give a written informed consent obtained according to local guidelines.
12. 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.

Exclusion Criteria:

1. 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.
2. Patients receiving ongoing radiation therapy or who received radiation therapy to the residual tumor masses \< 4 weeks from start of study drug.
3. Patients who have previously received systemic mTOR inhibitor (sirolimus, temsirolimus, everolimus, etc).
4. 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.
5. Patients with transformed follicular lymphoma.
6. Patients who received ibritumomab tiuxetan (Zevalin®), in order to avoid potential delayed kidney toxicities.
7. Patients who had myelosuppressive chemotherapy or biologic therapy \< 3 weeks from start of study drug.
8. 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.
9. Patients with active, bleeding diathesis.
10. Patients with a known history of HIV seropositivity.
11. Patients with known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to any of the excipients.
12. 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.
13. 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.
14. 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.
15. Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study drug start.
16. Patients unwilling to or unable to comply with the protocol.

Primary outcomes:
measure: Disease-free Survival (DFS)
timeFrame: 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:
measure: Overall Survival (OS)
timeFrame: From date of randomization to date of death due to any cause up to around 7 years
measure: Lymphoma-specific Survival (LSS)
timeFrame: From randomization to death documented as a result of lymphoma up to 7 years
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer and Research Centers SC
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group Dept of Highlands Oncology Grp
state: Arkansas
city: La Jolla
country: United States
facility: University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (3)
state: California
city: Los Angeles
country: United States
facility: USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisMedicalCenter(4)
state: California
city: Colorado Springs
country: United States
facility: University of Colorado Health
state: Colorado
city: Denver
country: United States
facility: Denver Health & Hospital Authority CACZ885M2301
state: Colorado
city: Greenwood Village
country: United States
facility: Rocky Mountain Cancer Centers RMCC
state: Colorado
city: Boynton Beach
country: United States
facility: University Cancer Institute
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center, LLC
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center Div. of Hematology & Oncology
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Hospital IU Cancer Center
state: Indiana
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center Office of Clinical Research
state: Louisiana
city: Burlington
country: United States
facility: Lahey Clinic Dept of Lahey Clinic (3)
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic - Rochester Dept. of MayoClinic-Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine Div. of Medical Oncology
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center Dartmouth
state: New Hampshire
city: Charlotte
country: United States
facility: Levine Cancer Institute Oncology
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center Dept. of WFUHS
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center SC-3
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2)
state: South Carolina
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas Cancer Centers of Carolinas (3
state: South Carolina
city: Memphis
country: United States
facility: University of Tennessee Cancer Institute SC-2
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD
state: Texas
city: Houston
country: United States
facility: University of Texas/MD Anderson Cancer Center Dept of MD Anderson (18)
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Dept.of Baylor College of Med.
state: Texas
city: San Antonio
country: United States
facility: South Texas Oncology and Hematology, PA South Texas Oncology (2)
state: Texas
city: Temple
country: United States
facility: Texas A&M HealthSciencesCtr-Scott & White Memorial Hospital CenterForCancerPrevention&Care
state: Texas
city: Burlington
country: United States
facility: University of Vermont Office of Clinical Trials Res.
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Health Systems SC-2
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Research Center at Roanoke Neurological Center SC
state: Virginia
city: Madison
country: United States
facility: Dean Health System
state: Wisconsin
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital Cancer Center Dept.ofWaukeshaMemorialHosp.
state: Wisconsin
city: La Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Douglas
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Greenslopes
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Clayton
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Geelong
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Innsbruck
country: Austria
facility: Novartis Investigative Site
state: Tyrol
city: Leoben
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Curitiba
country: Brazil
facility: Novartis Investigative Site
state: PR
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Campinas
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Brampton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Cambridge
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Mississauga
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Québec
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Guangzhou
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Bogotá
country: Colombia
facility: Novartis Investigative Site
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Novartis Investigative Site
city: Medellín
country: Colombia
facility: Novartis Investigative Site
city: Brno - Bohunice
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Hradec Kralove
country: Czechia
facility: Novartis Investigative Site
state: CZE
city: Olomouc
country: Czechia
facility: Novartis Investigative Site
state: CZE
city: Praha 10
country: Czechia
facility: Novartis Investigative Site
city: Alexandria
country: Egypt
facility: Novartis Investigative Site
city: Cairo
country: Egypt
facility: Novartis Investigative Site
city: Cairo
country: Egypt
facility: Novartis Investigative Site
city: Cairo
country: Egypt
facility: Novartis Investigative Site
city: Mansoura
country: Egypt
facility: Novartis Investigative Site
city: Amiens cedex1
country: France
facility: Novartis Investigative Site
city: Brest
country: France
facility: Novartis Investigative Site
city: La Roche sur Yon cedex 9
country: France
facility: Novartis Investigative Site
city: Limoges cedex
country: France
facility: Novartis Investigative Site
city: Pessac
country: France
facility: Novartis Investigative Site
city: Saint Priest en Jarez Cedex
country: France
facility: Novartis Investigative Site
city: Aachen
country: Germany
facility: Novartis Investigative Site
city: Bad Saarow
country: Germany
facility: Novartis Investigative Site
city: Bamberg
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
state: GR
city: Ioannina
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Heraklion Crete
country: Greece
facility: Novartis Investigative Site
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Gyor
country: Hungary
facility: Novartis Investigative Site
city: Kaposvar
country: Hungary
facility: Novartis Investigative Site
city: Pecs
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Tel Aviv
country: Israel
facility: Novartis Investigative Site
city: Brindisi
country: Italy
facility: Novartis Investigative Site
state: BR
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: San Giovanni Rotondo
country: Italy
facility: Novartis Investigative Site
state: FG
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Lecce
country: Italy
facility: Novartis Investigative Site
state: LE
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Rozzano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Modena
country: Italy
facility: Novartis Investigative Site
state: MO
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: PA
city: Piacenza
country: Italy
facility: Novartis Investigative Site
state: PC
city: Pescara
country: Italy
facility: Novartis Investigative Site
state: PE
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Potenza
country: Italy
facility: Novartis Investigative Site
state: PZ
city: Reggio Calabria
country: Italy
facility: Novartis Investigative Site
state: RC
city: Reggio Emilia
country: Italy
facility: Novartis Investigative Site
state: RE
city: Siena
country: Italy
facility: Novartis Investigative Site
state: SI
city: Venezia
country: Italy
facility: Novartis Investigative Site
state: VE
city: Nagoya-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Matsuyama-city
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Kure
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Kanazawa-city
country: Japan
facility: Novartis Investigative Site
state: Ishikawa
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Sendai-city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Suita-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Sunto-gun
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Koto
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Saida
country: Lebanon
facility: Novartis Investigative Site
city: México
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Novartis Investigative Site
state: Nuevo Leon
city: Grafton
country: New Zealand
facility: Novartis Investigative Site
state: Auckland
city: Wellington
country: New Zealand
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Jesus Maria
country: Peru
facility: Novartis Investigative Site
state: Lima
city: San Isidro
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Lublin
country: Poland
facility: Novartis Investigative Site
state: Lubelskie
city: Bydgoszcz
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Warsaw
country: Poland
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: N. Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Petrozavodsk
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Dammam
country: Saudi Arabia
facility: Novartis Investigative Site
city: Jeddah
country: Saudi Arabia
facility: Novartis Investigative Site
city: Riyadh
country: Saudi Arabia
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Cadiz
country: Spain
facility: Novartis Investigative Site
state: Andalucía
city: Sabadell
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Santander
country: Spain
facility: Novartis Investigative Site
state: Cantabria
city: Badalona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Majadahonda
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Pozuelo de Alarcon
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Pamplona
country: Spain
facility: Novartis Investigative Site
state: Navarra
city: San Sebastian
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Zürich
country: Switzerland
facility: Novartis Investigative Site
state: CH
city: Bellinzona
country: Switzerland
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Songkla
country: Thailand
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Antalya
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Talas / Kayseri
country: Turkey
facility: Novartis Investigative Site
city: Caracas
country: Venezuela
facility: Novartis Investigative Site
state: Distrito Capital
city: Caracas
country: Venezuela
facility: Novartis Investigative Site
state: Distrito Capital
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.