A Randomised Evaluation of Molecular Guided Therapy for Diffuse Large B-cell Lymphoma With Bortezomib (REMoDL-B)
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|ClinicalTrials.gov Identifier: NCT01324596|
Recruitment Status : Completed
First Posted : March 29, 2011
Last Update Posted : April 15, 2016
The aims of this study are:
- To evaluate the benefits of the addition of bortezomib to standard rituximab with cyclophosphamide, doxorubicin, vincristine, prednisolone (R-CHOP) therapy in Diffuse Large B-cell Lymphoma (DLBCL).
- To determine whether molecular phenotype effects the benefits derived from the addition of bortezomib.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Large B-Cell, Diffuse||Drug: Intravenous Drug: Bortezomib||Phase 3|
REMoDLB is a trial which aims to determine whether the addition of bortezomib (a drug that blocks the action of cellular complexes that break down proteins) to standard combination chemotherapy (called R-CHOP) improves how long patients with diffuse large B cell lymphoma survive without a recurrence of the disease. Results from recent research have suggested that patients can be divided into two biologically distinct subgroups labeled GCB (germinal centre derived B-cells like) and ABC (activated peripheral B-cells like).
GCB patients tend to do well with standard combination chemotherapy, but ABC patients have the majority of treatment failures. It is thought that ABC patients will benefit most from the addition of bortezomib.
The trial will be discussed with the patient. They will be asked to consent to molecular profiling of their tumour block whilst they have some time to consider whether they wish to enter the main trial. This will allow more time for this sample to be analysed and their particular biological subgroup to be determined.
All patients consenting to enter the main study will be given an initial cycle of RCHOP chemotherapy. Within each subgroup (ABC or GCB) patients will be randomly assigned to receive either RCHOP or RCHOP and bortezomib to ensure that the same number of each biological subgroup will receive the two treatments. All patients will then have 5 cycles of their assigned treatment regimen (either RCHOP or RCHOP and bortezomib). All patients will be followed up for a period of five years once they have completed their chemotherapy. The GCB group receiving RCHOP and bortezomib will be regularly checked to see if the new treatment is improving survival without recurrence of the disease. If the addition of bortezomib is not found to be beneficial for this group of patients this part of the trial will be stopped and all GCB patients will receive the standard treatment only (RCHOP).
It is anticipated that between 560 and 892 patients will be randomly allocated to the two treatments, the exact number depends on whether the GCB group receiving RCHOP and bortezomib is stopped or not.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Evaluation of Molecular Guided Therapy for Diffuse Large B-cell Lymphoma With Bortezomib|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||June 2015|
Active Comparator: Arm A: R-CHOP
Participants receive 6 cycles of conventional R-CHOP chemotherapy on a standard 21 day schedule: Rituximab 375mg/m2 intravenous Cyclophosphamide 750mg/m2 Intravenous Doxorubicin 50mg/m2 Intravenous Vincristine intravenous Prednisolone 100mg od orally
Experimental: Arm B: RB-CHOP
Participants in this arm will receive 1 cycle of conventional R-CHOP chemotherapy, followed by 5 cycles of R-CHOP:
Cyclophosphamide 750mg/m2 Intravenous Doxorubicin 50mg/m2 Intravenous Vincristine intravenous bortezomib - Intravenous Prednisolone 100mg od orally
- Progression Free Survival [ Time Frame: 2 years ]
- Overall survival [ Time Frame: 5 years ]
- Event-free survival [ Time Frame: 5 years ]
- Disease-free survival [ Time Frame: 5 years ]
- Time to progression [ Time Frame: 5 years ]
- Response duration [ Time Frame: 5 years ]
- Complete and overall response rates [ Time Frame: 5 years ]
- Evaluation of toxicity (according to CTCAE version 4.0) [ Time Frame: 5 years ]
- Quality of life and assessment of peripheral neuropathy [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324596
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|Principal Investigator:||Prof Peter Johnson||University Hospital Southampton NHS Foundation Trust|