Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-31 @ 1:57 PM
Study NCT ID:
NCT02060656
Status:
UNKNOWN
Last Update Posted:
2019-09-19
First Post:
2014-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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 1:1 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, 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
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
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-002620-32 | EUDRACT_NUMBER | None | View |