Prelude A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin - ND

• Conditions: Diffuse large B-cell lymphoma DLBCL; MedDRA version: 6.1Level: PTClassification code 10012821

• Registration Number: EUCTR2005-004630-41-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-30
• Last Update Posted: 10 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 459

Inclusion Criteria

Patients may be included in the study only if they meet all of the following criteria 1 have had a histologically confirmed diagnosis of DLBCL by the World Health Organization classification Harris et al. 1999 at the time of original diagnosis. Pathology must be reviewed and confirmed prior to enrollment at the investigational site where the patient is entered. Patients may be entered and randomized based on local pathology; however, an independent centralized pathology review will be performed on all enrolled patients see Section 6.4.1 . Patients with a prior history of an indolent lymphoma or a histological diagnosis of follicular Grade 3 lymphoma will not be eligible for enrollment. 2 if any gallium scan was performed, the most recent gallium scan must be negative. However, gallium scans are not a required study procedure. 3 if any PET scan was performed, the most recent PET scan must be negative. However, PET scans are not a required study procedure. 4 have completed six or eight 21-day cycles of R-CHOP, or six 14-day cycles of R-CHOP as first-line therapy for DLBCL. Refer to Section 5.5 for recommended regimens. The patient must have achieved a CR or CRu and have not subsequently progressed according to International Workshop criteria Cheson et al. 1999 . 5 have an IPI score 3 at time of original diagnosis refer to Protocol Attachment JCBJ.4 . 6 have had Stage 3 or 4 disease, or have had Stage 2 with bulky disease defined as 10 cm , at time of original diagnosis. 7 have given informed consent. 8 have an estimated life expectancy of at least 12 weeks. 9 have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group ECOG scale see Protocol Attachment JCBJ.7; Oken et al. 1982 . 10 exhibit patient compliance and geographic proximity that allow for adequate follow-up. 11 have adequate organ function as follows Hepatic total bilirubin 1.5 times upper limit of normal ULN ; alanine transaminase ALT and aspartate transaminase AST 2.5 times ULN Renal serum creatinine 1.5 times ULN Adequate bone marrow reserve platelets 50 x 109/L, absolute neutrophil count ANC 1.0 x 109/L, hemoglobin 8 g/dL. 12 male and female patients with reproductive potential must use an approved contraceptive method, if appropriate for example, intrauterine device IUD , birth control pills, or barrier device during and for 3 months after discontinuation of study treatment. Women with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment. 13 are at least 18 years of age. 14 Patient must receive on-study therapy no later than 42 days from their last cycle Day 1 of induction 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 subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria 1 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. 2 receive concurrent administration of any other systemic anticancer therapy. 3 have received radiation therapy to more than one targeted lesion local residual disease for treatment of lymphoma. 4 are pregnant or breastfeeding. 5 have central nervous system CNS metastases unless the patient has completed successful local therapy for CNS metastases and has been off of corticosteroids for at least 4 weeks before starting study therapy . 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. 6 have serious concomitant disorder, including active bacterial, fungal, or viral infection, incompatible with the study at the discretion of the investigator . 7 have human immunodeficiency virus HIV associated lymphomas. 8 have a 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. 9 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 see Protocol Attachment JCBJ.5 . 10 are unable to swallow tablets.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified