Phase II Study Comparing LR-GEM to R-GEM-P in Second-line Treatment of Diffuse Large B-cell Lymphoma (LEGEND) — LEGEND  

Diffuse Large B-Cell Lymphoma Clinical Trial

Official title: A Randomised Phase II Study Comparing LEnalidomide Plus Rituximab, GEmcitabine and Methylprednisolone (LR-GEM) to Rituximab, Gemcitabine, Methylprednisolone and cisplatiN (R-GEM-P) in Second-line Treatment of Diffuse Large B-cell Lymphoma (DLBCL).

Status Active, not recruiting

Clinical Trial Summary

This is a randomised, phase II open-labelled two-arm study comparing R-GEM-P and LR-GEM in second-line treatment of Diffuse Large B-cell lymphoma. Eligible patients will be randomised 1:1 between R-GEM-P and LR-GEM.

Clinical Trial Description

Objectives:

Primary

To assess the complete response rate to LR-GEM (lenalidomide, rituximab, gemcitabine and methylprednisolone) and R-GEM-P (rituximab, gemcitabine,cisplatin and methylprednisolone) following 3 cycles of induction treatment as secondline therapy for patients with Diffuse Large B-cell Lymphoma.

To investigate in both arms:

• Overall response rate following 3 cycles of induction treatment evaluated by IWG 2007 criteria

• Event-free survival

• Overall survival

• Rate of successful stem cell harvest

• Toxicity

• Subgroup analyses will be performed on the primary endpoint by cell-of-origin immunohistochemical subtype using the Choi method[2] (GCB vs non-GCB), morphological subtype (centroblastic vs immunoblastic vs other), IPI (0-1 vs ³2),and previous response to treatment (£12 vs > 12 months), and eligibility for ASCT at randomisation.

Treatment:

LR-GEM: lenalidomide plus rituximab, gemcitabine and methylprednisolone every 28 days. R-GEM-P: rituximab, gemcitabine, methylprednisolone and cisplatin every 28 days.

Assessment Schedule:

• Patients will be reviewed at baseline and prior to each scheduled dose of treatment for toxicity

• Radiological tumour assessment will be done with contrast-enhanced CT scan after the 1st and 3rd cycles in both arms.

• PET/CT scan will be performed at baseline and upon completion of induction treatment (3-4 weeks after last dose of chemotherapy). If PET/CT scan is performed with a contrast-enhanced CT, then patients do not need a separate CT scan.

• Follow up after completion of induction treatment will be at 3 monthly intervals for the first 12 months in Arm A and at monthly intervals for the first 12 months for patients in Arm B. Thereafter follow up in both Arm A and B will be at 6 monthly intervals for 2 years, then annually up until 5 years in total.

• CT scan at 3 & 12 months post induction treatment in both arms

• Following disease progression patients will be followed for survival every 3 months until death ;

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

• NCT number: NCT02060656
• Study type: Interventional
• Source: Royal Marsden NHS Foundation Trust
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 2013
• Completion date: August 2023