Clinical Trial: NCT01122472
Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | The Lymphoma Academic Research Organisation |
| Information Provided By: | The Lymphoma Academic Research Organisation |
| Last Update Posted: | 2021-07-26 |
Study Overview
Brief Summary
This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to explore the effect of maintenance therapy with lenalidomide versus placebo on progression-free survival (PFS) in patients treated with R-CHOP responding to induction therapy
For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs 73.6%), is considered clinically relevant.
Official Title
Conditions
Intervention / Treatment
- Drug: Lenalidomide
- Drug: Placebo
Other Study ID Numbers
- REMARC
Start Date
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | The Lymphoma Academic Research Organisation |
| Information Provided By: | The Lymphoma Academic Research Organisation |
| Last Update Posted: | 2021-07-26 |
Study Overview
Brief Summary
This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to explore the effect of maintenance therapy with lenalidomide versus placebo on progression-free survival (PFS) in patients treated with R-CHOP responding to induction therapy
For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs 73.6%), is considered clinically relevant.
Official Title
Conditions
Intervention / Treatment
- Drug: Lenalidomide
- Drug: Placebo
Other Study ID Numbers
- REMARC