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 (PILLAR2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00790036
First received: November 11, 2008
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Diffuse Large B-cell Lymphoma
Drug: RAD001
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Disease-free Survival (DFS) in poor risk patients with DLBCL after achieving CR following first-line R-chemotherapy who receive RAD001 versus patients who receive matching placebo [ Time Frame: until 279 DFS events are observed ] [ Designated as safety issue: No ]
    DFS is the time from date of randomization to the date of event defined as the first documented recurrence of the disease or death due to any cause.


Secondary Outcome Measures:
  • Overall survival (OS) in patients who receive RAD001 versus patients who receive matching placebo [ Time Frame: Until 338 deaths are observed ] [ Designated as safety issue: Yes ]
    OSS is defined as the time from date of randomization to date of death due to any cause. If the patient is not known to have died, survival will be censored at the date of the last contact.

  • Lymphoma-specific surviva (LSS) in patients who receive RAD001 versus patients who receive matching placebo [ Time Frame: Until 338 deaths are observed ] [ Designated as safety issue: Yes ]
    LSS is defined as time from randomization to death as a result of lymphoma, which means that death must be recorded as a result of lymphoma.

  • Safety profile of RAD001 in comparison to the matching placebo [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Number of adverse events in patients who receive RAD001 in comparison to matching placebo.


Estimated Enrollment: 727
Study Start Date: July 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 Drug: RAD001
RAD001 10 mg (two 5 mg tablets), daily for 12 months
Other Name: Everolimus
Placebo Comparator: Placebo Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 highly effective 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 of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 8 weeks after study drug administration. Highly effective contraception methods include:

    • Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
    • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
    • Male sterilization (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject.
    • Combination of any two of the following (a+b or a+c, or b+c):

      1. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
      2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
      3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
  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.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790036

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Hide Study Locations
Locations
United States, Arizona
Ironwood Cancer and Research Centers SC Active, not recruiting
Chandler, Arizona, United States, 85224
United States, Arkansas
Highlands Oncology Group Dept of Highlands Oncology Grp Completed
Fayetteville, Arkansas, United States, 72703
United States, California
Sutter Health Cancer Research Group California Cancer Care Withdrawn
Greenbrae, California, United States, 94904
University of California San Diego Dept of Moores Cancer Ctr (3) Active, not recruiting
La Jolla, California, United States, 92093-0658
USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisMedicalCenter(4) Active, not recruiting
Los Angeles, California, United States, 90033
Palo Alto Medical Foundation Hematology/Oncology Withdrawn
Mountain View, California, United States, 94040
California Pacific Medical Center Medical Research Institute Withdrawn
San Francisco, California, United States, 94120-7999
Redwood Regional Medical Group - Santa Rosa Dept. of RRMG (2) Withdrawn
Santa Rosa, California, United States, 94503
Stanford University Medical Center Dept. of Stanford University Withdrawn
Stanford, California, United States, 94304
United States, Colorado
Memorial Cancer Medicine Specialists Completed
Colorado Springs, Colorado, United States, 80909
Denver Health Medical Center CACZ885M2301 Active, not recruiting
Denver, Colorado, United States, 80204-4507
Rocky Mountain Cancer Centers RMCC Completed
Greenwood Village, Colorado, United States
United States, Connecticut
Hartford Hospital Cancer Clin Research Office Withdrawn
Hartford, Connecticut, United States, 06102
United States, Florida
University Cancer Institute Active, not recruiting
Boyton Beach, Florida, United States, 33426
Advanced Medical Specialties Withdrawn
Miami, Florida, United States, 33176
Cancer Centers of Florida PA Cancer Centers of FL-Ocoee (2) Withdrawn
Ocoee, Florida, United States, *see dep*
Hematology Oncology Associates of Treasure Coast Hematology Onc of the Treasure Withdrawn
Port Lucie, Florida, United States, 34952
United States, Georgia
University Cancer & Blood Center, LLC Active, not recruiting
Athens, Georgia, United States, 30607
Georgia Health Sciences University Dept. of MCG Withdrawn
Augusta, Georgia, United States, 30912
Columbus Regional Active, not recruiting
Columbus, Georgia, United States, 31904
United States, Hawaii
Straub Clinic & Hospital Straub Clinic & Hospital (3) Withdrawn
Honolulu, Hawaii, United States, 96813
United States, Illinois
Northwestern University Northwest Withdrawn
Chicago, Illinois, United States, 60611
Rush University Medical Center Div. of Hematology & Oncology Active, not recruiting
Chicago, Illinois, United States, 60612
Loyola University Medical Center /Cardinal Bernardin Cancer Loyola University (rm 101) Withdrawn
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana University Health Goshen Center for Cancer IU Cancer Center Active, not recruiting
Indianapolis, Indiana, United States, 46202
Hematology Oncology of Indiana Withdrawn
Indianapolis, Indiana, United States, 46260
United States, Kansas
University of Kansas Cancer Center Univ of Kansas (2) Withdrawn
Kansas City, Kansas, United States, 66160
United States, Kentucky
Kentuckiana Cancer Institute Kentuckiana Withdrawn
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University Health Sciences Center Office of Clinical Research Active, not recruiting
New Orleans, Louisiana, United States, 70112
United States, Maryland
St. Agnes Hospital SC Withdrawn
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Lahey Clinic Dept of Lahey Clinic (3) Active, not recruiting
Burlington, Massachusetts, United States, 01805
United States, Minnesota
Mayo Clinic - Rochester Dept. of MayoClinic-Rochester Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, Mississippi
North Mississippi Hematology /Oncology MS Hem & Onc Withdrawn
Tupelo, Mississippi, United States, 38801
United States, Missouri
Washington University School Of Medicine-Siteman Cancer Ctr Div. of Medical Oncology Terminated
St. Louis, Missouri, United States, 63110
United States, Nevada
Nevada Cancer Institute Dept. of Nevada Cancer (3) Withdrawn
Las Vegas, Nevada, United States, 89135
United States, New Hampshire
Dartmouth Hitchcock Medical Center Dartmouth Active, not recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2) Withdrawn
Morristown, New Jersey, United States, 07962
United States, New Mexico
University of New Mexico Cancer Center CancerResearch & Treatment (2) Withdrawn
Albuquerque, New Mexico, United States, 87131
United States, New York
NYU Langone Arena Oncology Dept.ofArenaOncologyAssoc(2) Withdrawn
Lake Success, New York, United States, 11042
United States, North Carolina
Cancer Care of Western North Carolina, PA Withdrawn
Asheville, North Carolina, United States, 28801
Levine Cancer Institute Oncology Active, not recruiting
Charlotte, North Carolina, United States, 28203
Wake Forest University Baptist Medical Center Dept. of WFUHS Active, not recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Oncology Partners Network Withdrawn
Cincinnati, Ohio, United States, 45245
University Hospitals of Cleveland Withdrawn
Cleveland, Ohio, United States, 44106-5065
Zangmeister Center / Mid Ohio Oncology/Hematology Mid Ohio Onc Hem (2) Withdrawn
Columbus, Ohio, United States, 43219
United States, Oregon
Northwest Cancer Specialists Compass Oncology -BKM Withdrawn
Portland, Oregon, United States, 97210
United States, Pennsylvania
University of Pittsburgh Medical Center SC-3 Completed
Pittsburgh, Pennsylvania, United States, 15213
Allegheny General Hospital Dept.ofAlleghenyCancerCtr (2) Withdrawn
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2) Active, not recruiting
Charleston, South Carolina, United States, 29425
Medical University of South Carolina Withdrawn
Charleston, South Carolina, United States, 29425
Cancer Centers of the Carolinas Cancer Centers of Carolinas (3 Active, not recruiting
Greenville, South Carolina, United States, 29605
Low Country Hematology Oncology Dept of Lowcountry Hem/Onc Withdrawn
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
University Oncology and Hematology Associates, PLLC Withdrawn
Chattanooga, Tennessee, United States, 37403
Family Cancer Center, PLC Family Cancer Center Withdrawn
Collierville, Tennessee, United States, 38017
University of Tennessee Cancer Institute SC-2 Active, not recruiting
Memphis, Tennessee, United States, 38104
The West Clinic Active, not recruiting
Memphis, Tennessee, United States, 38120
United States, Texas
US Oncology Central Monitoring Withdrawn
Dallas, Texas, United States, 75246
Texas Oncology, P.A. Sammons Cancer Ctr. Withdrawn
Dallas, Texas, United States, 75251
The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD Active, not recruiting
Fort Worth, Texas, United States, 76104
University of Texas/MD Anderson Cancer Center Dept of MD Anderson (18) Active, not recruiting
Houston, Texas, United States, 77030-4009
University of Texas, Houston Medical School UT Physicians Oncology Withdrawn
Houston, Texas, United States, 77030
Baylor College of Medicine Dept.of Baylor College of Med. Active, not recruiting
Houston, Texas, United States, 77030
South Texas Oncology and Hematology, PA South Texas Oncology (2) Active, not recruiting
San Antonio, Texas, United States, 78258
Texas A&M HealthSciencesCtr-Scott & White Memorial Hospital CenterForCancerPrevention&Care Active, not recruiting
Temple, Texas, United States, 76508
Texoma Cancer Center Withdrawn
Wichita Falls, Texas, United States, 76310
United States, Vermont
University of Vermont Office of Clinical Trials Res. Active, not recruiting
Burlington, Vermont, United States, 05404
United States, Virginia
University of Virginia Health Systems SC-2 Terminated
Charlottesville, Virginia, United States, 22908-0334
Blue Ridge Research Center at Roanoke Neurological Center SC Active, not recruiting
Roanoke, Virginia, United States, 24014
United States, Wisconsin
Dean Health System Active, not recruiting
Madison, Wisconsin, United States, 53717
Waukesha Memorial Hospital Cancer Center Dept.ofWaukeshaMemorialHosp. Active, not recruiting
Waukesha, Wisconsin, United States, 53188
Argentina
Novartis Investigative Site Completed
Caba, Buenos Aires, Argentina, C1221ADC
Novartis Investigative Site Withdrawn
Caba, Buenos Aires, Argentina, C1280AEB
Novartis Investigative Site Active, not recruiting
La Plata, Buenos Aires, Argentina, B1900AWT
Novartis Investigative Site Active, not recruiting
Buenos Aires, Argentina, C1114AAN
Novartis Investigative Site Withdrawn
Buenos Aires, Argentina, C1425AUM
Novartis Investigative Site Active, not recruiting
Cordoba, Argentina, X5016KEH
Australia, Queensland
Novartis Investigative Site Completed
Douglas, Queensland, Australia, 4810
Novartis Investigative Site Active, not recruiting
Greenslopes, Queensland, Australia, 4120
Australia, Victoria
Novartis Investigative Site Withdrawn
Box Hill, Victoria, Australia, 3128
Novartis Investigative Site Active, not recruiting
Clayton, Victoria, Australia, 3168
Novartis Investigative Site Active, not recruiting
Geelong, Victoria, Australia, 3220
Austria
Novartis Investigative Site Active, not recruiting
Innsbruck, Austria, 6020
Novartis Investigative Site Active, not recruiting
Leoben, Austria, A-8700
Novartis Investigative Site Active, not recruiting
Linz, Austria, 4010
Novartis Investigative Site Withdrawn
Linz, Austria, A-4020
Novartis Investigative Site Withdrawn
Linz, Austria, A-4010
Novartis Investigative Site Terminated
Wien, Austria, 1090
Novartis Investigative Site Active, not recruiting
Wien, Austria, 1140
Brazil
Novartis Investigative Site Active, not recruiting
Curitiba, PR, Brazil, 80060-900
Novartis Investigative Site Withdrawn
Rio de Janeiro, RJ, Brazil, 22260-020
Novartis Investigative Site Active, not recruiting
Porto Alegre, RS, Brazil, 90610-000
Novartis Investigative Site Active, not recruiting
Campinas, SP, Brazil, 13083-970
Novartis Investigative Site Withdrawn
São Paulo, SP, Brazil, 01401-901
Novartis Investigative Site Active, not recruiting
São Paulo, SP, Brazil, 05403-000
Novartis Investigative Site Active, not recruiting
São Paulo, SP, Brazil, 01224-000
Canada, Manitoba
Novartis Investigative Site Withdrawn
Winnepeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Novartis Investigative Site Active, not recruiting
Brampton, Ontario, Canada, L6R 3J7
Novartis Investigative Site Active, not recruiting
Cambridge, Ontario, Canada, N1R 3G2
Novartis Investigative Site Completed
Mississauga, Ontario, Canada, L5M 2V8
Novartis Investigative Site Completed
Mississauga, Ontario, Canada, L5A 2H1
Novartis Investigative Site Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L6
Novartis Investigative Site Active, not recruiting
Toronto, Ontario, Canada, M5G 2M9
Novartis Investigative Site Active, not recruiting
Toronto, Ontario, Canada, M4C 3E7
Canada, Quebec
Novartis Investigative Site Active, not recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Novartis Investigative Site Active, not recruiting
Montreal, Quebec, Canada, H1T 2M4
Novartis Investigative Site Active, not recruiting
Montreal, Quebec, Canada, H3A 1A1
Novartis Investigative Site Active, not recruiting
Québec, Quebec, Canada, G1J 1Z4
China, Hubei
Novartis Investigative Site Withdrawn
Wuhan, Hubei, China, 430030
Novartis Investigative Site Withdrawn
Wuhan, Hubei, China, 430022
China, Sichuan
Novartis Investigative Site Active, not recruiting
Chengdu, Sichuan, China, 610041
China, Zhejiang
Novartis Investigative Site Active, not recruiting
Hangzhou, Zhejiang, China, 310003
China
Novartis Investigative Site Active, not recruiting
Beijing, China, 100036
Novartis Investigative Site Active, not recruiting
Beijing, China, 100021
Novartis Investigative Site Active, not recruiting
Guangzhou, China, 510060
Novartis Investigative Site Active, not recruiting
Shanghai, China, 200025
Colombia
Novartis Investigative Site Withdrawn
Barranquilla, Cundinamarca, Colombia, 0000
Novartis Investigative Site Withdrawn
Bogota, Cundinamarca, Colombia, 111411
Novartis Investigative Site Active, not recruiting
Bogotá, Cundinamarca, Colombia
Novartis Investigative Site Terminated
Bucaramanga, Colombia
Novartis Investigative Site Withdrawn
Florida Blanca, Colombia
Novartis Investigative Site Active, not recruiting
Medellín, Colombia
Czech Republic
Novartis Investigative Site Active, not recruiting
Hradec Kralove, CZE, Czech Republic, 500 05
Novartis Investigative Site Active, not recruiting
Olomouc, CZE, Czech Republic, 775 20
Novartis Investigative Site Active, not recruiting
Brno - Bohunice, Czech Republic, 625 00
Novartis Investigative Site Active, not recruiting
Praha 10, Czech Republic, 100 34
Egypt
Novartis Investigative Site Completed
Alexandria, Egypt
Novartis Investigative Site Terminated
Cairo, Egypt
Novartis Investigative Site Active, not recruiting
Cairo, Egypt
Novartis Investigative Site Withdrawn
Cairo, Egypt
Novartis Investigative Site Active, not recruiting
Mansoura, Egypt
France
Novartis Investigative Site Active, not recruiting
Amiens cedex1, France, 80054
Novartis Investigative Site Withdrawn
Besancon cedex, France, 25030
Novartis Investigative Site Active, not recruiting
Brest, France, 29200
Novartis Investigative Site Completed
La Roche sur Yon cedex 9, France, 85925
Novartis Investigative Site Active, not recruiting
Limoges cedex, France, 87042
Novartis Investigative Site Withdrawn
Paris Cedex 4, France, 75181
Novartis Investigative Site Active, not recruiting
Pessac, France, 33604
Novartis Investigative Site Active, not recruiting
Saint Priest en Jarez Cedex, France, 42271
Germany
Novartis Investigative Site Active, not recruiting
Aachen, Germany, 52074
Novartis Investigative Site Active, not recruiting
Bad Saarow, Germany, 155226
Novartis Investigative Site Active, not recruiting
Bamberg, Germany, 96049
Novartis Investigative Site Withdrawn
Berlin, Germany, 13353
Novartis Investigative Site Withdrawn
Berlin, Germany, 14195
Novartis Investigative Site Withdrawn
Bonn, Germany, 53105
Novartis Investigative Site Withdrawn
Bonn, Germany, 53113
Novartis Investigative Site Active, not recruiting
Dresden, Germany, 01307
Novartis Investigative Site Withdrawn
Frankfurt, Germany, 60590
Novartis Investigative Site Active, not recruiting
Freiburg, Germany, 79106
Novartis Investigative Site Active, not recruiting
Hamburg, Germany, 20095
Novartis Investigative Site Withdrawn
Herrsching, Germany, 82211
Novartis Investigative Site Active, not recruiting
Koeln, Germany, 51067
Novartis Investigative Site Withdrawn
Landshut, Germany, 84028
Novartis Investigative Site Withdrawn
Magdeburg, Germany, 39120
Novartis Investigative Site Withdrawn
Marburg, Germany, 35043
Novartis Investigative Site Active, not recruiting
Muenchen, Germany, 81737
Novartis Investigative Site Withdrawn
Weilheim, Germany, 82362
Greece
Novartis Investigative Site Active, not recruiting
Heraklion Crete, Crete, Greece, GR-71110
Novartis Investigative Site Withdrawn
Alexandroupolis, GR, Greece, GR 68 100
Novartis Investigative Site Active, not recruiting
Athens, GR, Greece, 11527
Novartis Investigative Site Active, not recruiting
Athens, GR, Greece, 115 27
Novartis Investigative Site Withdrawn
Ioannina, GR, Greece, 455 00
Novartis Investigative Site Withdrawn
Athens, Greece, 11525
Novartis Investigative Site Active, not recruiting
Ioannina, Greece, 45500
Novartis Investigative Site Withdrawn
Thessaloniki, Greece, 57001
Novartis Investigative Site Withdrawn
Thessaloniki, Greece, GR 570 10
Hong Kong
Novartis Investigative Site Active, not recruiting
Hong Kong, Hong Kong
Hungary
Novartis Investigative Site Withdrawn
Budapest, Hungary, 1085
Novartis Investigative Site Withdrawn
Budapest, Hungary, 1097
Novartis Investigative Site Active, not recruiting
Budapest, Hungary, 1122
Novartis Investigative Site Active, not recruiting
Gyor, Hungary, H-9023
Novartis Investigative Site Active, not recruiting
Kaposvár, Hungary, 7400
Novartis Investigative Site Terminated
Pecs, Hungary, 7624
Novartis Investigative Site Active, not recruiting
Szeged, Hungary, H-6720
Israel
Novartis Investigative Site Active, not recruiting
Haifa, Israel, 31096
Novartis Investigative Site Active, not recruiting
Jerusalem, Israel, 91120
Novartis Investigative Site Active, not recruiting
Petach Tikva, Israel, 49100
Novartis Investigative Site Active, not recruiting
Ramat Gan, Israel, 52621
Novartis Investigative Site Active, not recruiting
Tel-Aviv, Israel, 64239
Italy
Novartis Investigative Site Withdrawn
Bologna, BO, Italy, 40138
Novartis Investigative Site Completed
Brindisi, BR, Italy, 72100
Novartis Investigative Site Active, not recruiting
Catania, CT, Italy, 95124
Novartis Investigative Site Completed
San Giovanni Rotondo, FG, Italy, 71013
Novartis Investigative Site Active, not recruiting
Firenze, FI, Italy, 50134
Novartis Investigative Site Active, not recruiting
Genova, GE, Italy, 16132
Novartis Investigative Site Withdrawn
Genova, GE, Italy, 16132
Novartis Investigative Site Active, not recruiting
Lecce, LE, Italy, 73100
Novartis Investigative Site Withdrawn
Milano, MI, Italy, 20122
Novartis Investigative Site Active, not recruiting
Milano, MI, Italy, 20141
Novartis Investigative Site Active, not recruiting
Rozzano, MI, Italy, 20089
Novartis Investigative Site Active, not recruiting
Modena, MO, Italy, 41100
Novartis Investigative Site Active, not recruiting
Palermo, PA, Italy, 90146
Novartis Investigative Site Active, not recruiting
Piacenza, PC, Italy, 29100
Novartis Investigative Site Active, not recruiting
Pescara, PE, Italy, 65124
Novartis Investigative Site Active, not recruiting
Pisa, PI, Italy, 56126
Novartis Investigative Site Active, not recruiting
Potenza, PZ, Italy, 85100
Novartis Investigative Site Active, not recruiting
Reggio Calabria, RC, Italy, 89124
Novartis Investigative Site Active, not recruiting
Reggio Emilia, RE, Italy, 42123
Novartis Investigative Site Active, not recruiting
Siena, SI, Italy, 53100
Novartis Investigative Site Withdrawn
Varese, VA, Italy, 21100
Novartis Investigative Site Active, not recruiting
Venezia, VE, Italy, 30174
Novartis Investigative Site Withdrawn
Napoli, Italy, 80132
Japan
Novartis Investigative Site Active, not recruiting
Nagoya-city, Aichi, Japan, 466-8650
Novartis Investigative Site Active, not recruiting
Kashiwa, Chiba, Japan, 277-8577
Novartis Investigative Site Active, not recruiting
Matsuyama, Ehime, Japan, 790-8524
Novartis Investigative Site Active, not recruiting
Kure, Hiroshima, Japan, 737-0023
Novartis Investigative Site Active, not recruiting
Kanazawa, Ishikawa, Japan, 920-8641
Novartis Investigative Site Active, not recruiting
Sendai-city, Miyagi, Japan, 980-8574
Novartis Investigative Site Active, not recruiting
Osaka-city, Osaka, Japan, 545-8586
Novartis Investigative Site Active, not recruiting
Suita-city, Osaka, Japan, 565-0871
Novartis Investigative Site Active, not recruiting
Sunto-gun, Shizuoka, Japan, 411-8777
Novartis Investigative Site Withdrawn
Utsunomiya, Tochigi, Japan, 320-0834
Novartis Investigative Site Active, not recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Novartis Investigative Site Active, not recruiting
Koto, Tokyo, Japan, 135-8550
Novartis Investigative Site Active, not recruiting
Shinjuku-ku, Tokyo, Japan, 160-0023
Novartis Investigative Site Active, not recruiting
Fukuoka, Japan, 811-1395
Novartis Investigative Site Active, not recruiting
Kyoto, Japan, 602-8566
Korea, Republic of
Novartis Investigative Site Active, not recruiting
Goyang, Gyeonggi-do, Korea, Republic of, 410-769
Novartis Investigative Site Active, not recruiting
Seoul, Korea, Korea, Republic of, 135-710
Novartis Investigative Site Active, not recruiting
Seoul, Korea, Korea, Republic of, 120-752
Novartis Investigative Site Active, not recruiting
Seoul, Korea, Republic of, 738-736
Lebanon
Novartis Investigative Site Active, not recruiting
Beirut, Lebanon, 166378
Novartis Investigative Site Active, not recruiting
Beirut, Lebanon
Novartis Investigative Site Active, not recruiting
Beirut, Lebanon, 6301
Novartis Investigative Site Terminated
Beirut, Lebanon, 1107 2020
Novartis Investigative Site Active, not recruiting
Saida, Lebanon
Mexico
Novartis Investigative Site Withdrawn
Mexico, Distrito Federal, Mexico, 06726
Novartis Investigative Site Active, not recruiting
México, Distrito Federal, Mexico, 01120
Novartis Investigative Site Withdrawn
México, Distrito Federal, Mexico, 02990
Novartis Investigative Site Withdrawn
Metepec, Edo. de México, Mexico, 52140
Novartis Investigative Site Completed
Monterrey, Nuevo León, Mexico, 64460
Novartis Investigative Site Withdrawn
Puebla, Mexico, 072480
New Zealand
Novartis Investigative Site Active, not recruiting
Grafton, Auckland, New Zealand
Novartis Investigative Site Active, not recruiting
Wellington, New Zealand
Norway
Novartis Investigative Site Withdrawn
Oslo, Norway, 0407
Novartis Investigative Site Active, not recruiting
Oslo, Norway, NO-0379
Peru
Novartis Investigative Site Active, not recruiting
Jesus Maria, Lima, Peru, 11
Novartis Investigative Site Active, not recruiting
San Isidro, Lima, Peru, 27
Poland
Novartis Investigative Site Recruiting
Lublin, Lubelskie, Poland, 20-080
Novartis Investigative Site Withdrawn
Gliwice, Slaskie, Poland, 44-101
Novartis Investigative Site Active, not recruiting
Bydgoszcz, Poland, 85-796
Novartis Investigative Site Not yet recruiting
Katowice, Poland, 40032
Novartis Investigative Site Recruiting
Lodz, Poland, 93-509
Novartis Investigative Site Active, not recruiting
Warsaw, Poland, 02-106
Novartis Investigative Site Withdrawn
Warszawa, Poland, 02-781
Novartis Investigative Site Not yet recruiting
Wroclaw, Poland, 50-367
Russian Federation
Novartis Investigative Site Withdrawn
Syktyvkar, Komi Republic, Russian Federation, 167904
Novartis Investigative Site Withdrawn
Chelyabinsk, Russian Federation, 454087
Novartis Investigative Site Terminated
Moscow, Russian Federation, 125167
Novartis Investigative Site Terminated
Moscow, Russian Federation, 115478
Novartis Investigative Site Active, not recruiting
Moscow, Russian Federation, 129110
Novartis Investigative Site Active, not recruiting
N. Novgorod, Russian Federation, 603000
Novartis Investigative Site Active, not recruiting
Petrozavodsk, Russian Federation, 185019
Novartis Investigative Site Active, not recruiting
Saint-Petersburg, Russian Federation, 197341
Novartis Investigative Site Active, not recruiting
St Petersburg, Russian Federation, 191024
Novartis Investigative Site Active, not recruiting
St. Petersburg, Russian Federation, 197758
Novartis Investigative Site Withdrawn
Tula, Russian Federation, 300053
Saudi Arabia
Novartis Investigative Site Active, not recruiting
Dammam, Saudi Arabia, 15215
Novartis Investigative Site Active, not recruiting
Jeddah, Saudi Arabia, 21423
Novartis Investigative Site Withdrawn
Riyadh, Saudi Arabia, 11426
Singapore
Novartis Investigative Site Active, not recruiting
Singapore, Singapore, 169610
Novartis Investigative Site Active, not recruiting
Singapore, Singapore, 169608
Novartis Investigative Site Active, not recruiting
Singapore, Singapore, 119228
Slovakia
Novartis Investigative Site Completed
Bratislava, Slovak Republic, Slovakia, 833 10
Novartis Investigative Site Completed
Kosice, Slovak Republic, Slovakia, 040 66
Novartis Investigative Site Active, not recruiting
Bratislava, Slovakia, 833 10
Novartis Investigative Site Completed
Martin, Slovakia, 03601
South Africa
Novartis Investigative Site Withdrawn
Durban, South Africa, 4091
Novartis Investigative Site Withdrawn
Johannesburg, South Africa, 2000
Novartis Investigative Site Withdrawn
Johannesburg, South Africa, 2196
Novartis Investigative Site Withdrawn
Johannesburg, South Africa, 2195
Novartis Investigative Site Withdrawn
Pretoria, South Africa, 0027
Novartis Investigative Site Withdrawn
Pretoria, South Africa, 0001
Spain
Novartis Investigative Site Active, not recruiting
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site Active, not recruiting
Cadiz, Andalucía, Spain, 11009
Novartis Investigative Site Terminated
Sabadell, Barcelona, Spain, 08208
Novartis Investigative Site Completed
Santander, Cantabria, Spain, 39008
Novartis Investigative Site Active, not recruiting
Badalona, Catalunya, Spain, 08916
Novartis Investigative Site Active, not recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Active, not recruiting
Barcelona, Catalunya, Spain, 08003
Novartis Investigative Site Terminated
Barcelona, Cataluña, Spain, 08028
Novartis Investigative Site Active, not recruiting
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigative Site Withdrawn
Lugo, Galicia, Spain, 27003
Novartis Investigative Site Withdrawn
Palma De Mallorca, Islas Baleares, Spain, 07120
Novartis Investigative Site Active, not recruiting
Majadanonda, Madrid, Spain, 28220
Novartis Investigative Site Active, not recruiting
Pozuelo de Alarcón, Madrid, Spain, 28223
Novartis Investigative Site Completed
Pamplona, Navarra, Spain, 31002
Novartis Investigative Site Active, not recruiting
Pamplona, Navarra, Spain, 31008
Novartis Investigative Site Active, not recruiting
San Sebastian, Pais Vasco, Spain, 20014
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28006
Switzerland
Novartis Investigative Site Active, not recruiting
Luzern, CH, Switzerland, 6000
Novartis Investigative Site Completed
Basel, Switzerland, 4031
Novartis Investigative Site Active, not recruiting
Bellinzona, Switzerland, 6500
Thailand
Novartis Investigative Site Active, not recruiting
Bangkok, Thailand, 10400
Novartis Investigative Site Active, not recruiting
Bangkok, Thailand, 10700
Novartis Investigative Site Active, not recruiting
Bangkok, Thailand, 10330
Novartis Investigative Site Completed
Songkla, Thailand, 90110
Turkey
Novartis Investigative Site Active, not recruiting
Ankara, Turkey, 06100
Novartis Investigative Site Completed
Ankara, Turkey, 06460
Novartis Investigative Site Active, not recruiting
Antalya, Turkey, 07070
Novartis Investigative Site Withdrawn
Antalya, Turkey, 07070
Novartis Investigative Site Active, not recruiting
Istanbul, Turkey, 34093
Novartis Investigative Site Active, not recruiting
Talas / Kayseri, Turkey, 38039
United Arab Emirates
Novartis Investigative Site Withdrawn
Al Ain - Abu Dhabi, United Arab Emirates
Venezuela
Novartis Investigative Site Terminated
Caracas, Distrito Capital, Venezuela, 1011
Novartis Investigative Site Terminated
Caracas, Distrito Capital, Venezuela, 1010
Novartis Investigative Site Withdrawn
Caracas, Estado Miranda, Venezuela, 1061
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticlas Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00790036     History of Changes
Other Study ID Numbers: CRAD001N2301, 2008-000498-40
Study First Received: November 11, 2008
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Diffuse large B cell lymphoma
poor risk
R-IPI 3-5
adjuvant therapy
after R-CHOP

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Everolimus
Sirolimus
Rituximab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 21, 2014