Grade 1 or 2 follicular lymphoma MedDRA version: 17.1 Level: PT Classification code 10003899 Term: B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 17.1 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 17.1 Level: LLT Classification code 10029473 Term: Nodular (follicular) lymphoma System Organ Class:
Conditions
Interventions
Product Name: Enzastaurin
Product Code: LY317615
Pharmaceutical Form: Tablet
INN or Proposed INN: Enzastaurin
Current Sponsor code: LY317615
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study only if they meet all of the following criteria: [1] Have had a histologically confirmed diagnosis of Grade 1 or 2 FL, according to World Health Organization classification (Harris et al.1999), at the original time of diagnosis. Pathology must be confirmed locally prior to enrollment at the investigational site. [2] Have Ann Arbor Stage III or IV disease (see Protocol Attachment S011.4). [3] Must be chemonaive OR have relapsed disease after receiving only one prior chemotherapy regimen. The chemotherapy must have been completed at least 6 months prior to first dose of study treatment. Relapse after one prior course of single-agent rituximab treatment (in the chemonaive setting) is also allowed if completed at least 6 months prior to first dose of study treatment. [4] Patients must not require cytoreductive therapy for at least 3 months from first dose of study treatment, in the opinion of the investigator. [5] Previous radiation therapy is allowed, but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry. Lesions that have been irradiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy. [6] Have measurable disease as defined by International Working Group recommendations (Cheson et al. 1999; Protocol Attachment S011.5). [7] Have adequate organ function including the following: • Adequate bone marrow reserve: absolute neutrophil count (ANC) =1.5 × 109/L, platelet count =75.0 × 109/L, and hemoglobin >9.0 g/dL. • Hepatic: bilirubin =1.5 times the upper limit of normal (× ULN); aspartate transaminase (AST) and alanine transaminase (ALT) =2.5 × ULN, or AST and ALT =65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: [13] Are unable to swallow tablets. [14] Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin (refer to Section 5.7.1). [15] Are receiving concurrent administration of any other antitumor therapy. [16] Are pregnant or breastfeeding. [17] Have a serious concomitant systemic disorder (including active bacterial, fungal, or viral infection) that, in the opinion of the investigator, would compromise the patient’s ability to adhere to the protocol. [18] Have a 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 (Protocol Attachment S011.7). [19] Have any tumor mass >10cm. [20] Have “B” symptoms: unexplained weight loss (>10%), unexplained fever (> 38°C or 100.4°F), or night sweats. [21] Have Grade 3 FL, or transformed lymphoma. [22] Are human immunodeficiency virus (HIV) positive. [23] Have a prior malignancy (other than FL, or adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer), unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. [24] Have central nervous system (CNS) metastases. A screening CT or MRI before enrollment in the absence of a clinical suspicion of brain metastases is not required. [25] 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Evaluation of the primary analysis (RR) will occur after all patients have progressed, have died, have been lost to follow up, or have been followed for at least 12 months from start of study treatment. ;Main Objective: To evaluate the antitumor activity, as measured by tumor response rate of enzastaurin in patients with follicular lymphoma.;Primary end point(s): The primary outcome measure is the tumor response rate. A response rate of 20% (CI 95%, 10.8% to 32.3%) would be considered a clinically meaningful response in the study.;Secondary Objective: To assess the following efficacy variables: - Progression-free survival (PFS) - Time to response (TtR) - Duration of response (DoR). To evaluate the safety of enzastaurin in this patient population. To assess biomarkers relevant to enzastaurin and the disease state, as well as their correlation to clinical outcomes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progressive Free Survival (PFS) and Duration of Response (DoR) will be calculated, endpoint not defined. ;Timepoint(s) of evaluation of this end point: At same time of the primary analysis. | — |
Countries
Germany, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed