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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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00790036
First received: November 11, 2008
Last updated: September 26, 2014
Last verified: September 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.


Enrollment: 740
Study Start Date: July 2009
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (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

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Locations
United States, Arizona
Ironwood Cancer and Research Centers SC
Chandler, Arizona, United States, 85224
United States, Arkansas
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States, 72703
United States, California
University of California San Diego Dept of Moores Cancer Ctr (3)
La Jolla, California, United States, 92093-0658
USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisMedicalCenter(4)
Los Angeles, California, United States, 90033
United States, Colorado
Memorial Cancer Medicine Specialists
Colorado Springs, Colorado, United States, 80909
Denver Health Medical Center CACZ885M2301
Denver, Colorado, United States, 80204-4507
Rocky Mountain Cancer Centers RMCC
Greenwood Village, Colorado, United States
United States, Florida
University Cancer Institute
Boyton Beach, Florida, United States, 33426
United States, Georgia
University Cancer & Blood Center, LLC
Athens, Georgia, United States, 30607
Columbus Regional
Columbus, Georgia, United States, 31904
United States, Illinois
Rush University Medical Center Div. of Hematology & Oncology
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Health Goshen Center for Cancer IU Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Tulane University Health Sciences Center Office of Clinical Research
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Lahey Clinic Dept of Lahey Clinic (3)
Burlington, Massachusetts, United States, 01805
United States, Minnesota
Mayo Clinic - Rochester Dept. of MayoClinic-Rochester
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine Div. of Medical Oncology
St. Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth Hitchcock Medical Center Dartmouth
Lebanon, New Hampshire, United States, 03756
United States, North Carolina
Levine Cancer Institute Oncology
Charlotte, North Carolina, United States, 28203
Wake Forest University Baptist Medical Center Dept. of WFUHS
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
University of Pittsburgh Medical Center SC-3
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2)
Charleston, South Carolina, United States, 29425
Cancer Centers of the Carolinas Cancer Centers of Carolinas (3
Greenville, South Carolina, United States, 29605
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
University of Tennessee Cancer Institute SC-2
Memphis, Tennessee, United States, 38104
United States, Texas
The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD
Fort Worth, Texas, United States, 76104
Baylor College of Medicine Dept.of Baylor College of Med.
Houston, Texas, United States, 77030
University of Texas/MD Anderson Cancer Center Dept of MD Anderson (18)
Houston, Texas, United States, 77030-4009
South Texas Oncology and Hematology, PA South Texas Oncology (2)
San Antonio, Texas, United States, 78258
Texas A&M HealthSciencesCtr-Scott & White Memorial Hospital CenterForCancerPrevention&Care
Temple, Texas, United States, 76508
United States, Vermont
University of Vermont Office of Clinical Trials Res.
Burlington, Vermont, United States, 05404
United States, Virginia
University of Virginia Health Systems SC-2
Charlottesville, Virginia, United States, 22908-0334
Blue Ridge Research Center at Roanoke Neurological Center SC
Roanoke, Virginia, United States, 24014
United States, Wisconsin
Dean Health System
Madison, Wisconsin, United States, 53717
Waukesha Memorial Hospital Cancer Center Dept.ofWaukeshaMemorialHosp.
Waukesha, Wisconsin, United States, 53188
Argentina
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La Plata, Buenos Aires, Argentina, B1900AWT
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Buenos Aires, Argentina, C1114AAN
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Cordoba, Argentina, X5016KEH
Australia, Queensland
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Douglas, Queensland, Australia, 4810
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Greenslopes, Queensland, Australia, 4120
Australia, Victoria
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Clayton, Victoria, Australia, 3168
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Geelong, Victoria, Australia, 3220
Austria
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Innsbruck, Austria, 6020
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Leoben, Austria, A-8700
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Linz, Austria, 4010
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Wien, Austria, 1090
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Wien, Austria, 1140
Brazil
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Curitiba, PR, Brazil, 80060-900
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Porto Alegre, RS, Brazil, 90610-000
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Campinas, SP, Brazil, 13083-970
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Sao Paulo, SP, Brazil, 05403-000
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São Paulo, SP, Brazil, 01224-000
Canada, Ontario
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Brampton, Ontario, Canada, L6R 3J7
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Cambridge, Ontario, Canada, N1R 3G2
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Mississauga, Ontario, Canada, L5M 2V8
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Mississauga, Ontario, Canada, L5A 2H1
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M5G 2M9
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Toronto, Ontario, Canada, M4C 3E7
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
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Montreal, Quebec, Canada, H3A 1A1
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Montreal, Quebec, Canada, H1T 2M4
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Québec, Quebec, Canada, G1J 1Z4
China, Sichuan
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Chengdu, Sichuan, China, 610041
China, Zhejiang
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Hangzhou, Zhejiang, China, 310003
China
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Beijing, China, 100036
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Beijing, China, 100021
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Guangzhou, China, 510060
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Shanghai, China, 200025
Colombia
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Bogotá, Cundinamarca, Colombia
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Bucaramanga, Colombia
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Medellín, Colombia
Czech Republic
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Hradec Kralove, CZE, Czech Republic, 500 05
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Olomouc, CZE, Czech Republic, 775 20
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Brno - Bohunice, Czech Republic, 625 00
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Praha 10, Czech Republic, 100 34
Egypt
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Alexandria, Egypt
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Cairo, Egypt
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Mansoura, Egypt, 35516
France
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Amiens cedex1, France, 80054
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Brest, France, 29200
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La Roche sur Yon cedex 9, France, 85925
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Limoges cedex, France, 87042
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Pessac, France, 33604
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Saint Priest en Jarez Cedex, France, 42271
Germany
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Aachen, Germany, 52074
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Bad Saarow, Germany, 155226
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Bamberg, Germany, 96049
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Dresden, Germany, 01307
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Freiburg, Germany, 79106
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Hamburg, Germany, 20095
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Koeln, Germany, 51067
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Muenchen, Germany, 81737
Greece
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Athens, GR, Greece, 115 27
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Heraklion Crete, GR, Greece, 711 10
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Ioannina, GR, Greece, 455 00
Hong Kong
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Hong Kong, Hong Kong
Hungary
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Budapest, Hungary, 1122
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Gyor, Hungary, H-9023
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Kaposvár, Hungary, 7400
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Pecs, Hungary, 7624
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Szeged, Hungary, H-6720
Israel
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Haifa, Israel, 31096
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Jerusalem, Israel, 91120
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Petach Tikva, Israel, 49100
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Ramat Gan, Israel, 52621
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Tel-Aviv, Israel, 64239
Italy
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Brindisi, BR, Italy, 72100
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Catania, CT, Italy, 95124
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San Giovanni Rotondo, FG, Italy, 71013
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Firenze, FI, Italy, 50134
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Genova, GE, Italy, 16132
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Lecce, LE, Italy, 73100
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Milano, MI, Italy, 20141
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Rozzano, MI, Italy, 20089
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Modena, MO, Italy, 41100
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Palermo, PA, Italy, 90146
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Piacenza, PC, Italy, 29100
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Pescara, PE, Italy, 65124
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Pisa, PI, Italy, 56126
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Potenza, PZ, Italy, 85100
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Reggio Calabria, RC, Italy, 89124
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Reggio Emilia, RE, Italy, 42123
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Siena, SI, Italy, 53100
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Venezia, VE, Italy, 30174
Japan
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Nagoya-city, Aichi, Japan, 466-8650
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Kashiwa, Chiba, Japan, 277-8577
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Matsuyama, Ehime, Japan, 790-8524
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Kure, Hiroshima, Japan, 737-0023
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Kanazawa, Ishikawa, Japan, 920-8641
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Sendai-city, Miyagi, Japan, 980-8574
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Osaka-city, Osaka, Japan, 545-8586
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Suita-city, Osaka, Japan, 565-0871
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Sunto-gun, Shizuoka, Japan, 411-8777
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Chuo-ku, Tokyo, Japan, 104-0045
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Koto, Tokyo, Japan, 135-8550
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Shinjuku-ku, Tokyo, Japan, 160-0023
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Fukuoka, Japan, 811-1395
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Kyoto, Japan, 602-8566
Korea, Republic of
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Goyang, Gyeonggi-do, Korea, Republic of, 410-769
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Seoul, Korea, Korea, Republic of, 120-752
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Seoul, Korea, Korea, Republic of, 135-710
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Seoul, Korea, Republic of, 738-736
Lebanon
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Beirut, Lebanon
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Beirut, Lebanon, 1107 2020
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Beirut, Lebanon, 6301
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Beirut, Lebanon, 166378
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Saida, Lebanon
Mexico
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México, Distrito Federal, Mexico, 01120
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Monterrey, Nuevo León, Mexico, 64460
New Zealand
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Grafton, Auckland, New Zealand
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Wellington, New Zealand
Norway
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Oslo, Norway, NO-0379
Peru
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Jesus Maria, Lima, Peru, 11
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San Isidro, Lima, Peru, 27
Poland
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Lublin, Lubelskie, Poland, 20-080
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Bydgoszcz, Poland, 85-796
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Katowice, Poland, 40032
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Lodz, Poland, 93-509
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Warsaw, Poland, 02-106
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Wroclaw, Poland, 50-367
Russian Federation
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Moscow, Russian Federation, 129110
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Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 125167
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N. Novgorod, Russian Federation, 603000
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Petrozavodsk, Russian Federation, 185019
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Saint-Petersburg, Russian Federation, 197341
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St Petersburg, Russian Federation, 191024
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St. Petersburg, Russian Federation, 197758
Saudi Arabia
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Dammam, Saudi Arabia, 15215
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Jeddah, Saudi Arabia, 21423
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Riyadh, Saudi Arabia, 11426
Singapore
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Singapore, Singapore, 169608
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Singapore, Singapore, 169610
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Singapore, Singapore, 119228
Slovakia
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Bratislava, Slovak Republic, Slovakia, 833 10
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Kosice, Slovak Republic, Slovakia, 040 66
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Bratislava, Slovakia, 833 10
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Martin, Slovakia, 03601
Spain
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Sevilla, Andalucia, Spain, 41013
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Cadiz, Andalucía, Spain, 11009
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Sabadell, Barcelona, Spain, 08208
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Santander, Cantabria, Spain, 39008
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Badalona, Catalunya, Spain, 08916
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Barcelona, Catalunya, Spain, 08035
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Barcelona, Catalunya, Spain, 08003
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Barcelona, Cataluña, Spain, 08028
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Valencia, Comunidad Valenciana, Spain, 46010
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Majadanonda, Madrid, Spain, 28220
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Pozuelo de Alarcón, Madrid, Spain, 28223
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Pamplona, Navarra, Spain, 31008
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Pamplona, Navarra, Spain, 31002
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San Sebastian, Pais Vasco, Spain, 20014
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Madrid, Spain, 28006
Switzerland
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Luzern, CH, Switzerland, 6000
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Basel, Switzerland, 4031
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Bellinzona, Switzerland, 6500
Thailand
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Bangkok, Thailand, 10400
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Bangkok, Thailand, 10330
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Bangkok, Thailand, 10700
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Songkla, Thailand, 90110
Turkey
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Ankara, Turkey, 06100
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Ankara, Turkey, 06460
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Antalya, Turkey, 07070
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Istanbul, Turkey, 34093
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Talas / Kayseri, Turkey, 38039
Venezuela
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Caracas, Distrito Capital, Venezuela, 1010
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Caracas, Distrito Capital, Venezuela, 1011
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: September 26, 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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014