An evaluation of therapy for B-cell lymphoma with Bortezomib
| ISRCTN | ISRCTN51837425 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51837425 |
| EudraCT/CTIS number | 2010-022422-32 |
| ClinicalTrials.gov number | NCT01324596 |
| Secondary identifying numbers | UKCRN ID: 9800 |
- Submission date
- 30/03/2011
- Registration date
- 30/03/2011
- Last edited
- 05/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Mrs Christine May
Scientific
Scientific
University of Southampton Clinical Trials Unit
MP131
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Study information
| Study design | Randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A Randomised Evaluation of Molecular guided therapy for Diffuse large B-cell Lymphoma with Bortezomib |
| Study acronym | REMoDLB |
| Study objectives | This study of treatment for diffuse large Bcell lymphoma aims to determine whether adding bortezomib to standard combination chemotherapy and rituximab (RCHOP) can improve progression free survival. Molecular studies have indicated the heterogenous biology of this disease identifying two subgroups (ABC and GCB) and this knowledge will be applied prospectively to determine whether a subgroup of patients might benefit more from the addition of bortezomib. Patients will be randomised to one of two groups (RBCHOP or RCHOP) on the basis of their molecular subgroup. |
| Ethics approval(s) | 10/H0405/79; First MREC approval date 24/01/2011 |
| Health condition(s) or problem(s) studied | Diffuse large B-cell lymphoma |
| Intervention | RB-CHOP, Rituximab, Cyclophsophamide, vincristine, Prednisolone, Doxorubicin, Bortezomib; R-CHOP, Rituximab, Cyclophosphamide, Doxorubicin, Prenisolone, Vincristine; Follow Up Length: 60 month(s); Study Entry : Single Randomisation only |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Bortezomib |
| Primary outcome measure | Progression-free survival; Timepoint(s): The primary endpoint is progression-free survival. |
| Secondary outcome measures | Disease-free survival; Timepoint(s): Disease-free survival will be measured from the time of documentation of disease-free state (CR or C; Event-free survival (time to treatment failure); Timepoint(s): Event-free survival (time to treatment failure) is measured from the day of registration to any trea; Overall survival; Timepoint(s): Overall survival will be measured from the day of registration to the date of death from any cause; Response duration; Timepoint(s): Response duration is defined as the time from documentation of response (ie,CR, CRu or PR) until the; Response Evaluation; Timepoint(s): Response will be assessed in accordance with the International Workshop Standardized Response Criter; Time to progression; Timepoint(s): Time to progression (TTP) is defined as the time from registration until documented lymphoma progres |
| Overall study start date | 13/04/2011 |
| Completion date | 12/04/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 940; UK Sample Size: 940; Description: 940 patients with DLBCL |
| Total final enrolment | 1128 |
| Key inclusion criteria | 1. Histologically confirmed Diffuse large B-cell lymphoma (DLBCL), expressing CD20 2. Sufficient diagnostic material should be available to forward to Haematological Malignancy Diagnostic Service (HDMS) for gene expression profiling and central pathology review 3. Core biopsies are acceptable, however the molecular profiling success rate is inferior compared to larger surgically acquired tissue samples 4. Best diagnostic practice encourages investigators to seek the latter approach whenever clinically appropriate 5. Not previously treated for lymphoma and fit enough to receive combination chemoimmunotherapy with curative intent 6. Age >18 years 7. Stage IAX (bulk defined as lymph node diameter >10cm) to stage IV disease and deemed to require a full course of chemotherapy 8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 9. Adequate bone marrow function with platelets >100x109/L; neutrophils >1.0x109/L at study entry, unless lower figures are attributable to lymphoma 10. Serum creatinine <150µmol/L, measured or calculated creatinine clearance >30mls/min, serum bilirubin <35µmol/L and transaminases <2.5x upper limit of normal at the time of study entry, unless attributable to lymphoma 11. Cardiac function sufficient to tolerate 300mg/m2 of doxorubicin 12. A pre-treatment echocardiogram is not mandated, but recommended in patients considered at higher risk of anthracycline cardiotoxicity 13. No concurrent uncontrolled medical condition 14. Life expectancy >3 months 15. Adequate contraceptive precautions for all patients of child bearing potential 16. A negative serum pregnancy test for females of child bearing potential or those <2 years after the onset of the menopause 17. Patients will have provided written informed consent 18. Target gender: male and female 19. Lower age limit 18 years |
| Key exclusion criteria | 1. Previous history of treated or untreated indolent lymphoma, however newly diagnosed patients with DLBCL who are found to also have small cell infiltration of the bone marrow or other diagnostic material (discordant lymphoma) will be eligible. 2. Uncontrolled systemic infection 3. History of cardiac failure of uncontrolled angina 4. Clinical CNS involvement 5. Serological positivity for Hepatitis C, B or known HIV infection. Viral serological testing is not mandated for study entry, but considered standard of care. Patients who are HepBsAg positive will not be eligible. 6. Serious medical or psychiatric illness likely to affect participation or that may compromise the ability to give informed consent 7. Active malignancy other than fully excised squamous or basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix in the preceding 5 years 8. History of allergic reaction to substances containing boron or mannitol 9. Patient unwilling to abstain from green tea and preparations made from green tea as bortezomib may interact with these 10. Any co-existing medical or psychological condition that would compromise ability to give informed consent |
| Date of first enrolment | 13/04/2011 |
| Date of final enrolment | 12/04/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Southampton Clinical Trials Unit
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
Southampton University Hospitals NHS Trust (UK)
University/education
University/education
University of Southampton Clinical Trials Unit
MP131
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
"ROR" |
https://ror.org/0485axj58 |
|---|
Funders
Funder type
Industry
Janssen-Cilag Ltd
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2019 | 24/04/2019 | Yes | No |
Editorial Notes
05/06/2025: The link to the Cancer Research UK record was updated in the plain English summary field.
24/04/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment has been added from the reference.
3. The clinicaltrials.gov number has been added.
03/04/2019: The condition has been changed from "Topic: National Cancer Research Network; Subtopic: Lymphoma; Disease: Lymphoma (non-Hodgkin's)" to "Diffuse large B-cell lymphoma" following a request from the NIHR.
