Ignite Creation Date:
2024-05-06 @ 2:32 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02060656
Status:
UNKNOWN
Last Update Posted:
2019-09-19
First Post:
2014-01-22
Brief Title:
Phase II Study Comparing LR-GEM to R-GEM-P in Second-line Treatment of Diffuse Large B-cell Lymphoma LEGEND
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Royal Marsden NHS Foundation Trust
Study Overview
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:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEGEND
Brief 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 11 between R-GEM-P and LR-GEM
Detailed Description:
Objectives
Primary
To assess the complete response rate to LR-GEM lenalidomide rituximab gemcitabine and methylprednisolone and R-GEM-P rituximab gemcitabinecisplatin 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 method2 GCB vs non-GCB morphological subtype centroblastic vs immunoblastic vs other IPI 0-1 vs ³2and 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
PETCT scan will be performed at baseline and upon completion of induction treatment 3-4 weeks after last dose of chemotherapy If PETCT 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
Primary
To assess the complete response rate to LR-GEM lenalidomide rituximab gemcitabine and methylprednisolone and R-GEM-P rituximab gemcitabinecisplatin 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 method2 GCB vs non-GCB morphological subtype centroblastic vs immunoblastic vs other IPI 0-1 vs ³2and 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
PETCT scan will be performed at baseline and upon completion of induction treatment 3-4 weeks after last dose of chemotherapy If PETCT 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-002620-32 | EUDRACT_NUMBER | None | None |