An evaluation of therapy for B-cell lymphoma with Bortezomib | Recruiting
An evaluation of therapy for B-cell lymphoma with Bortezomib
Trial Source

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Health Conditions
  • Topic: National Cancer Research Network
  • Subtopic: Lymphoma
  • Disease: Lymphoma (non-Hodgkin's)
Mrs Christine May
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Primary Contact Details
Recruitment Status
Primary Trial ID Number
Research Details
  • 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.
Phase III
Study Design
Randomised trial
Study Type

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
Primary Outcome Measures
  • 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
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Result Reports
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Age Range
Who Can Participate
Number of Participants
Planned Sample Size: 940; UK Sample Size: 940; Description: 940 patients with DLBCL
Participant 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
Participant 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
Trial Location(s)
Southampton General Hospital
SO16 6YD
Trial Contact(s)
Primary Trial Contact
Mrs Christine May
Other Trial Contacts
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Countries Recruiting
United Kingdom
Scientific Title
A Randomised Evaluation of Molecular guided therapy for Diffuse large B-cell Lymphoma with Bortezomib
EudraCT Number
  • Janssen-Cilag Ltd
Other Study ID Numbers
UKCRN ID: 9800
Southampton University Hospitals NHS Trust (UK)
Key Dates

Recruitment Start Date

13 Apr 2011

Recruitment End Date

12 Apr 2020

Trial Start Date

13 Apr 2011

Trial End Date

12 Apr 2020

Date Assigned

30 Mar 2011

Last Updated

04 Oct 2011