A Phase 2/3 Multicenter, Randomized Open-Label Study to Compare the Efficacy and Safety of Lenalidomide (Revlimid) Versus Investigator’s Choice in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma - ND
- Conditions
- Patients with Relapsed or Refractory Diffuse Large B-cell LymphomaMedDRA version: 9.1Level: PTClassification code 10012821
- Registration Number
- EUCTR2009-013483-38-IT
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 396
Histologically proven diffuse large B-cell non-Hodgkin’s lymphoma [DLBCL] by central pathology review a. Note that submission of an FFPE tumor block or appropriately stained slides from a fresh biopsy is required. If a fresh specimen is not readily available, slides prepared from the archival specimen supporting the initial DLBCL diagnosis may be submitted to fulfill this inclusion criterion. 2. Ability to provide a tumor or lymph node biopsy specimen is required during the Screening Phase for gene expression and IHC assays. In the event that the tumor or disease bearing node is not accessible for biopsy, recruitment into the study must be approved by the Celgene medical monitor first. 3. Relapsed or refractory to: a. One combination chemotherapy regimen containing rituximab and an anthracycline; and b. At least one additional combination chemotherapy regimen or receipt of stem cell transplant (SCT). If a patient is documented as ineligible for both the additional combination chemotherapy and SCT at the time of inclusion in the study, then they are exempted from this requirement Note: c. For patients who have relapsed or progressed after achieving a response (defined as CR or PR), documented, Investigator-assessed relapse or progression after the last treatment is required. d. For patients who are refractory to their last treatment (defined as not having achieved a CR or PR prior to enrollment by Investigator-assessment), documented progression will not be required. e. For patients whom the physician considers ineligible for SCT at the time of enrollment because of one or more of the following reasons, documentation of SCT ineligibility is required. • Age > 65 years • Comorbidity for patients < 65 years • Comorbidity is defined as any condition including laboratory abnormalities or clinical symptoms such as e.g. cardiac insufficiency and severe pulmonary diseases that places the patient at an unacceptable risk if he/she undergoes transplant. • Patient declines transplant • Physician considers that patient`s disease cannot be adequately treated by autologous transplantation • Possible reasons include, active disease following salvage therapy or insufficient CD34 cell collection f. For patients whom the physician considers ineligible for 2nd line combination chemotherapy at the time of enrollment because of one or more of the following reasons, documentation of the ineligibility is required • Poor performance status • Major organ dysfunction or significant medical condition that places the patients at unacceptable risk • Patient refuses multi-agent chemotherapy 4. Must have measurable disease on cross sectional imaging by CT/MRI that is at least 2.0 cm in the longest diameter and measurable in two perpendicular dimensions. (CT is to be performed with contrast unless it is medically contraindicated.) 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1,or 2. 6. Life expectancy of greater than 3 months. 7. Must understand and voluntarily sign an informed consent form. 8. Must be >=18 years of age at the time of signing the informed consent form. 9. Must be able to adhere to the study visit schedule and other protocol requirements. 10. Females of FCBP must: a. Have a negative medically supervised pregnancy test prior to starting of study therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subject
Diagnosis of lymphoma histologies other than diffuse large B-cell lymphoma. Patients with history of lowgrade B-cell NHL; evidence of concurrent, follicular lymphoma; or history of known transformed large-cell NHL. 2. Prior history of malignancies, other than diffuse large B-cell lymphoma, unless the patient has been free of the disease for = 3 years. Exceptions to the = 3 year time limit include history of the following: a. Basal cell carcinoma of the skin b. Squamous cell carcinoma of the skin c. Carcinoma in situ of the cervix d. Carcinoma in situ of the breast e. Incidental histological finding of prostate cancer (TNM stage of T1a or T1b) 3. Prior use of lenalidomide. 4. Patients in whom autologous or allogeneic SCT is considered appropriate at the time of inclusion in the study. 5. Prior allogeneic SCT with persistent donor hematopoiesis. 6. Known seropositive for, or history of, active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible. 7. Neuropathy Grade 4. 8. Active central nervous system (CNS) lymphoma with the exception of those patients whose CNS lymphoma has been treated with chemotherapy, radiotherapy or surgery, have remained asymptomatic for 12 weeks (3 months) and demonstrate no CNS lymphoma as shown by lumbar puncture, CT/brain MRI are eligible. Patients with a history of CNS involvement or CNS symptoms will be required to have negative CSF cytology examination and a head CT during the Screening Phase (known and active CNS or leptomeningeal involvement). 9. Patients who are at a high risk for a thromboembolic event and are not willing to take venous thromboembolic event (VTE) prophylaxis. 10. Any of the following laboratory abnormalities: a. Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L) b. Platelet count < 50,000/mm3 (50 x 109/L) c. Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) > 3.0 x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma d. Serum bilirubin > 1.5 x ULN except in cases of Gilberts Syndrome and documented liver involvement by lymphoma e. Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL/min 11. Chemotherapy, radiotherapy, investigational anticancer therapy or major surgery within 28 days of Day 1 dosing. a. Patients with rapidly progressing disease who have recovered from all prior treatment related toxicities may be able to start Day 1 dosing in less than 28 days from their prior treatment upon approval by the sponsor. . 12. Uncontrolled intercurrent illness including, but not limited to: a. Ongoing or active infection requiring parenteral antibiotics b. Uncontrolled diabetes mellitus as defined by the Investigator c. Chronic symptomatic congestive heart failure (Class III or IV of the New York Heart Association Classification for Heart Disease) d. Unstable angina pectoris, angioplasty, stenting, or myocardial infarctions within 6 months e. Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia. Patients with controlled atrial fibrillation that is asymptomatic are eligible. 13. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form. 14. Pregnant or
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method