PRELUDE:Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin

Lilly

Status and phase: Completed; Phase 3

Conditions: Non Hodgkin Lymphoma

Treatments: Drug: enzastaurin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00332202

H6Q-MC-JCBJ (Other Identifier)

9823

PRELUDE (Other Identifier)

Details and patient eligibility

About

This clinical research study is to investigate the prevention of relapse in patients with diffuse large B cell lymphoma (DLBCL) using enzastaurin daily.

This is a randomised trial which compares Enzastaurin to Placebo (dummy treatment), the chance of receiving Enzastaurin is 2 to 1.

Enrollment: 758 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of diffuse large B cell lymphoma
• Recently completed R-CHOP therapy and achieved remission
• International Prognostic Index (IPI) score 3,4,5
• At least 18 years of age
• Agree to study follow-up schedule

Exclusion criteria

• Have received therapy other than R-CHOP for lymphoma
• Serious medical condition such as infection,second cancer,heart disease
• Received radiation to more than one lesion
• Unable to swallow tablets

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

758 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: enzastaurin

B

Placebo Comparator group

Treatment:

Drug: placebo