Diffuse large B-cell lymphoma MedDRA version: 8.1 Level: LLT Classification code 10012818 Term: Diffuse large B-cell lymphoma
Conditions
Sponsors
Cardiff and Vale NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The principal inclusion criteria is:- a) Informed consent both for the study and for the additional research on excess diagnostic material b) Age over 18 years c) Histologically confirmed DLBCL (centrally reviewed). Ideally fresh biopsy material should be available at diagnosis d) Bulky stage 1A-1V disease e) CD20 positive disease f) Previously untreated disease g) No prior diagnosis of indolent lymphoma, including histological transformation h) No clinical evidence of CNS lymphoma i) No active malignancy, other than BCC or squamous cell carcinoma of the skin or carcinoma of the cervix in situ, for the past 10 years j) Life expectancy > 3 months k) Adequate contraceptive precautions for women of childbearing age l) No concurrent uncontrolled medical condition Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The principal exclusion criteria is:- a) Transformed follicular, T-cell or Hodgkin lymphoma b) Prior chemotherapy for lymphoma c) Prior extended radiotherapy for lymphoma d) Platelets < 30 x 10^9/l within 14 days prior to enrollment e) Neutrophils <1.0 x 10^9/l within 14 days prior to enrollment f) Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis. g) Pregnancy or breast feeding h) HIV positive disease i) CNS lymphoma j) Other serious uncontrolled medical condition k) Life expectancy of less than 3 months l) Pre-existing neuropathy or neuropathic pain – grade 2 or greater (NCI CTCAE version 3 criteria) m) Severe hepatic impairment n) Previous allergy to boron or mannitol containing substances
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Diffuse large B cell lymphoma is the commonest lymphoma in adults. Standard therapy in the UK is R-CHOP chemotherapy. The proteasome inhibitor, Bortezomib, has been shown to be active in treatment of some lymphomas. The main objective of this trial is to compare the toxicity of R-CHOP chemotherapy with R-CHOP chemotherapy plus bortezomib in patients with diffuse large B-cell lymphoma (DLBCL). ;Secondary Objective: The secondary objectives of the trial are to:- (a)Compare the response rates to treatment in the two treatment arms. (b) Compare the one year progression free survival rate in patients with diffuse large B-cell lymphoma treated with standard treatment with or without bortezomib. (c) Compare the use of immunohistochemistry versus micro-array technology for the identification of the subtypes of diffuse large B-cell lymphoma (ie germinal centre type DLBCL and activated B cell type DLBCL). This research will be undertaken on diagnostic biopsy samples where available. Ultimately the results from this part of the study will be correlated with patient response to both treatment regimens. ;Primary end point(s): The primary endpoint in the study will be toxicity. The study involves the addition of an extra agent to a chemotherapy regimen that already has significant toxicities. The new agent, bortezomib, may well confer significant benefits to patients when added to additional therapy but may also increase treatment toxicities. This trial is designed to monitor patients carefully for toxicity. This is of primary importance in this study and we will close the study if excessive toxicity is seen in the experimental arm of the study. However, there are now data available from other groups showing that this combination of bortezomib plus R-CHOP has an acceptable toxicity profile in comparable patient groups with DLBCL when given at the doses proposed in this study. | — |
Countries
United Kingdom
Outcome results
None listed