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
NCT ID: NCT00790036
Last Updated: 2017-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
742 participants
INTERVENTIONAL
2009-07-24
2016-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Everolimus
Participants who received Everolimus 10 mg (two 5 mg tablets), daily for 12 months
Everolimus
Everolimus was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.
Placebo
Participants who received Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
Everolimus Placebo
Everolimus placebo was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.
Interventions
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Everolimus
Everolimus was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.
Everolimus Placebo
Everolimus placebo was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Ironwood Cancer and Research Centers SC
Chandler, Arizona, United States
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States
University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (3)
La Jolla, California, United States
USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisMedicalCenter(4)
Los Angeles, California, United States
University of Colorado Health
Colorado Springs, Colorado, United States
Denver Health & Hospital Authority CACZ885M2301
Denver, Colorado, United States
Rocky Mountain Cancer Centers RMCC
Greenwood Village, Colorado, United States
University Cancer Institute
Boynton Beach, Florida, United States
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Columbus Regional
Columbus, Georgia, United States
Rush University Medical Center Div. of Hematology & Oncology
Chicago, Illinois, United States
Indiana University Hospital IU Cancer Center
Indianapolis, Indiana, United States
Tulane University Health Sciences Center Office of Clinical Research
New Orleans, Louisiana, United States
Lahey Clinic Dept of Lahey Clinic (3)
Burlington, Massachusetts, United States
Mayo Clinic - Rochester Dept. of MayoClinic-Rochester
Rochester, Minnesota, United States
Washington University School of Medicine Div. of Medical Oncology
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center Dartmouth
Lebanon, New Hampshire, United States
Levine Cancer Institute Oncology
Charlotte, North Carolina, United States
Wake Forest University Baptist Medical Center Dept. of WFUHS
Winston-Salem, North Carolina, United States
University of Pittsburgh Medical Center SC-3
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2)
Charleston, South Carolina, United States
Cancer Centers of the Carolinas Cancer Centers of Carolinas (3
Greenville, South Carolina, United States
University of Tennessee Cancer Institute SC-2
Memphis, Tennessee, United States
The West Clinic
Memphis, Tennessee, United States
The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD
Fort Worth, Texas, United States
University of Texas/MD Anderson Cancer Center Dept of MD Anderson (18)
Houston, Texas, United States
Baylor College of Medicine Dept.of Baylor College of Med.
Houston, Texas, United States
South Texas Oncology and Hematology, PA South Texas Oncology (2)
San Antonio, Texas, United States
Texas A&M HealthSciencesCtr-Scott & White Memorial Hospital CenterForCancerPrevention&Care
Temple, Texas, United States
University of Vermont Office of Clinical Trials Res.
Burlington, Vermont, United States
University of Virginia Health Systems SC-2
Charlottesville, Virginia, United States
Blue Ridge Research Center at Roanoke Neurological Center SC
Roanoke, Virginia, United States
Dean Health System
Madison, Wisconsin, United States
Waukesha Memorial Hospital Cancer Center Dept.ofWaukeshaMemorialHosp.
Waukesha, Wisconsin, United States
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Chengdu, Sichuan, China
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Lublin, Lublin Voivodeship, Poland
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Bydgoszcz, , Poland
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Dammam, , Saudi Arabia
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Bellinzona, , Switzerland
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Bangkok, , Thailand
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Bangkok, , Thailand
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Songkhla, , Thailand
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Talas / Kayseri, , Turkey (Türkiye)
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Caracas, Distrito Federal, Venezuela
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Caracas, Distrito Federal, Venezuela
Countries
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References
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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.
Related Links
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Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Other Identifiers
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2008-000498-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRAD001N2301
Identifier Type: -
Identifier Source: org_study_id
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