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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) versus Matching Placebo after Patients have Achieved Complete Response with First-Line Rituximab Chemotherapy.
Open to Accrual
Defintions of terms and FAQ about clinical trials.
Ann Mohrbacher, M.D.
Other Trial Staff:
Nancy Berman, R.N., Christine Duran, D.M.
to see study documents.
You may participate in this study if:
Histologically confirmed Stage III-IV (or Stage II bulky disease defined as any tumor mass >10 cm in largest 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)
Patient defined as poor risk with IPI of 3, 4, or 5 at time of original diagnosis
At least 18 years of age
Must have achieved CR based on the revised IWRC following first-line R-CHOP treatment. RT in combination with R-CHOP is acceptable if RT ended by the time of R-CHOP completion. CR from R-CHOP must be confirmed by clinical and radiologic evaluation along with BM confirmation (if BM was involved by lymphoma before the R-CHOP treatment). Local pathology report on the BM biopsy is acceptable. If BM was not involved by lymphoma before R-CHOP treatment, then BM confirmation after R-CHOP is not required.
Patients who received a minimum 6 cycles of R-CHOP treatment and maximum 8 cycles of R-CHOP treatment. Any variation of CHOP (R-CHOP-14, R-CHOP-21) is acceptable. Liposomal doxorubicin, epirubicin, or pirarubicin (also known as therarubicin) is acceptable.
Last treatment cycle with R-CHOP must be 6-12 weeks prior to start of study drug.
ECOG performance status 0, 1, or 2
Willing to provide a portion of tumor tissue from original diagnosis or lymph node to confirm diagnosis
AGC = / > 1.0; platelets = / > 100,000; Hgb = / > 9.0 (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); SGOT < / = 3 x uln
Creatinine < / = 2 x uln
Women of childbearing potential must have had a negative serum pregnancy test 14 days prior to the start of study drug plus a negative local urine pregnancy test on Day 1, Cycle 1 prior to treatment and must be willing to use adequate methods of contraception during the study and for 8 weeks after study drug administration.
Capable of swallowing intact study medication tablets; able to follow directions regarding taking study drug, or have a daily caregiver responsible for administering study drug.
Signed an approved study-specific informed consent and HIPAA
You may not participate in this study if:
Evidence of disease according to the revised IWRC after completion of the first-line R-CHOP treatment prior to study entry
Receiving ongoing RT or who received RT to the residual tumor masses after R-CHOP
Previously received systemic mTOR inhibitor (sirolimus, temsirolimus, everolimus, etc)
Evidence of current CNS involvement with lymphoma. (Patients who have only had prophylactic intrathecal or iv chemotherapy against CNS disease are eligible)
Transformed follicular lymphoma
Received ibritumomab tiuxetan (Zevalin) to avoid potential delayed kidney toxicities
Prior myelosuppressive chemotherapy or biologic therapy <3 weeks from start of study drug
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 rheumatic, adrenal insufficiency, or asthma.
Active, bleeding diathesis
Known history of HIV seropositivity, or other active viral infections
Known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to any of the excipients
Any severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study such as: [a] unstable angina pectoris, symptomatic CHF (NYHA II, III, IV), MI < / = 6 months prior to first study drug, serious uncontrolled cardiac arrhythmia, CVA < / = 6 months before study drug start; [b] 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; [c] poorly controlled DM as defined by fasting serum glucose >2.0 x uln; [d] 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; [e] non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by this study drug, such as severe HTN that is not controlled with medical management and thyroid abnormalities whose thyroid function cannot be maintained in the normal range by medication; [f] liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis, or chronic persistent hepatitis (defined as positive HBsAg and/or detectable level of HBV-DNA; detectable level of HCV-RNA, at screening for patients who must be tested.
History of another primary malignancy < / = 3 years, except non-melanoma skin cancer and carcinoma in-situ of uterine cervix
Pregnant or breastfeeding females. Female patients who are pregnant or breastfeeding, or adults of reproductive potential must use effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes.
Using other investigational agents or who had received investigational drugs < / = 4 weeks prior to study drug start
Unwilling to or unable to comply with the protocol
For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or
To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.