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

Eli Lilly and Company0 sites758 target enrollmentApril 17, 2007

ConditionsHigh-risk Diffuse Large B-cell Lymphoma (DLBCL )MedDRA version: 14.1 Level: HLT Classification code 10012819 Term: Diffuse large B-cell lymphomas System Organ Class: 100000004851 Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: High-risk Diffuse Large B-cell Lymphoma (DLBCL )
Sponsor: Eli Lilly and Company
Enrollment: 758
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 17, 2007

End Date

July 31, 2013

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

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 Protocol Section 6\.4\.1\). Commonly accepted histological variants of DLBCL, such as immunoblastic lymphoma, primary mediastinal B\-cell lymphoma, and T\-cell rich B\-cell lymphoma are allowed.
•\[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, as judged by local radiologist and/or physician (an independent centralized radiology review will also be performed on these patients). Exceptions may be made (after consultation with the Lilly clinical research physician) for patients with PET\-positive lesions in which a subsequent confirmation procedure (for instance, biopsy) reveals the lesion is not due to DLBCL. However, PET scans are not a required study procedure. (See Protocol Section 6\.1\.1 for more information.)
•\[4]have completed six to eight 21\-day cycles of R\-CHOP, or six to eight 14\-day cycles of R\-CHOP as first\-line therapy for DLBCL. (Refer to Section 5\.5 for recommended regimens.) Patient must have achieved a CR or CRu (and have not subsequently progressed) according to International Workshop criteria (Cheson et al. 1999\), or must be PET scan negative (according to Juweid et al. 2007\), as judged by local radiologist and/or physician (an independent centralized radiology review will also be performed on these patients). Exceptions may be made (after consultation with the Lilly clinical research physician) for patients with PET\-positive lesions in which a subsequent confirmation procedure (for instance, biopsy) reveals the lesion is not due to DLBCL.
•\[5]have an IPI score ?3 at time of original diagnosis (refer to Protocol Attachment 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 7; Oken et al. 1982\).

Exclusion Criteria

•Patients will be excluded from the study if they meet any of the following criteria:
•\[15]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
•\[16]receive concurrent administration of any other systemic anticancer therapy. Also, any systemic anti\-cancer agent (for example, methotrexate or etoposide, and including investigational agents) initiated for treatment of DLBCL in combination with R\-CHOP is not allowed. Patients who had been receiving chronic therapy such as hormonal therapy (for example, tamoxifen), low\-dose (7\.5 mg/week) methotrexate, or corticosteroids prior to the diagnosis and treatment of DLBCL, may continue to receive these therapies while on study, after agreement with the Lilly clinical research physician; however, initiation of these medications while the patient is on study is not allowed. Intrathecal prophylaxis is allowed.
•\[17]have received radiation therapy to more than one targeted lesion (local residual disease) for treatment of lymphoma or have not recovered from the acute effects of radiation therapy prior to study entry.
•\[18]are pregnant or breastfeeding.
•\[19]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.
•\[20]have serious concomitant disorder, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator).
•\[21]are known to be HIV positive.
•\[22]have a second primary malignancy (except adequately treated non\-melanomatous skin cancer, or other cancer that is considered cured by surgical resection or radiation). Patients who had another malignancy in the past, but have been disease\-free for more than 5 years, are eligible.
•\[23]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 Attachment 5\). It is recommended that patients with a prolonged QT interval corrected for heart rate (QTc) \> 450/470 msec (males/females) at baseline on electrocardiogram (ECG), and patients who have a congenital long QT syndrome in their own or family medical history should be excluded, at the investigator’s discretion. It is recommended that QTc be calculated using Fridericia correction formula (QTcF; see Attachment 10\). A patient may still be entered on study with prolonged QT\-interval only after discussion and agreement between the principal investigator and the Lilly clinical research physician.