high-risk diffuse large B-cell lymphoma (DLBCL ) MedDRA version: 8.1 Level: LLT Classification code 10012822 Term: Diffuse large B-cell lymphoma refractory
Conditions
Sponsors
Eli Lilly and Company limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients may be included in the study only if they meet all of the following criteria: [1] Histology diagnosis of DLBCL or transformed (CD20+) indolent lymphoma by the World Health Organization classification (Harris et al. 1999) at the time of relapse. In the case that histology diagnosis is not available, cytology diagnosis is accepted. [2] Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale (see Protocol Attachment S013.6; Oken et al. 1982). [3] Have relapsed/progressed after CR, CRu or PR obtained in 1st or 2nd line treatment, or patients that have not progressed after SD obtained in 1st or 2nd line. [4] Prior treatment with at least one anthracycline-containing regimen. [5] Patients must have finished an interval of no less than 4 weeks from the completion of prior chemotherapy before receiving study treatment. [6] Measurable disease according to Cheson criteria (lymph node greater than 1.5 cm in its longest transverse diameter by CT scan) (see Protocol Attachment S013.5). [7] Estimated life expectancy of at least 12 weeks. [8] Patient compliance and geographic proximity that allow adequate follow-up. [9] Adequate organ function including the following: • Hepatic: total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: [13] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. [14] Allogeneic transplantation. Prior autologous transplantation is allowed. [15] More than 2 prior anti-cancer treatment regimens. [16] Are pregnant or breastfeeding. [17] Central nervous system (CNS) metastases (unless the patient has completed successful local treatment for CNS metastases and has been off of corticosteroids for at least 4 weeks before starting study treatment). In the absence of a clinical suspicion of brain metastases, no screening computed tomography (CT) or magnetic resonance imaging (MRI) scan before enrollment is required. [18] Have a serious concomitant systemic disorder (including active bacterial, fungal, or viral infection) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study. [19] Human immunodeficiency virus (HIV) associated lymphomas. [20] Second primary malignancy (except adequately treated basal cell carcinoma of the skin). Patients who had another malignancy in the past, but have been disease-free for more than 5 years, are eligible. [21] Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV (see Protocol Attachment S013.4). [22] Inability to swallow tablets. [23] Previous exposure to gemcitabine or oxaliplatin. [24] Are unable to discontinue concurrent administration of carbamazepine, phenobarbital, or phenytoin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective : evaluation of progression free survival on R-GEMOX and enzastaurin, 1 year after treatment start, in patients with relapsed DLBCL or transformed (CD20+) indolent lymphoma, who are older than 60 years. Patients who are younger than 60 may be included if they are not eligible for HDC followed by ASCT;Secondary Objective: Secondary objectives: • Evaluation of best response (CR, CRu, PR, SD, progression) during R-GEMOX • Evaluation of progression free survival including Year 2 and Year 4 • Evaluation of overall survival including Year 1, Year 2, and Year 4 • Evaluation of event free survival including Year 1, Year 2 and Year 4 • Assess biomarkers relevant to enzastaurin and disease state and their correlation to clinical outcome; • Characterize pharmacokinetics of enzastaurin and its metabolite when administered in combination with R-GEMOX in the patients participating for safety assessment. ;Primary end point(s): Progression Free Survival at 1 year is the primary efficacy endpoint. Overall PFS time is defined as the time from the date of first treatment with study medication to the first date of disease progression or death from any cause. For patients not known to have died as of the data cut-off date and who do not have disease progression, overall PFS will be censored at the date of the last tumor assessment. For patients who receive subsequent anticancer treatment (after discontinuation from the study treatment) prior to disease progression, overall PFS will be censored at the date of the latest progression-free assessment prior to the initiation of subsequent treatment. | — |
Countries
France, Germany
Outcome results
None listed