Diffuse Large B-cell Lymphoma
Conditions
Interventions
Trade Name: Velcade (Bortezomib)
Product Name: Bortezomib (Velcade)
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Bortezomib
Concentration unit: mg/m2 milligram(s)/squar
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed DLBCL, expressing CD20. Sufficient diagnostic material should be available to forward to HDMS for gene expression profiling and central pathology review. • Not previously treated for lymphoma and fit enough to receive combination chemoimmunotherapy with curative intent. • Age >18 years • Stage IAX (bulk defined as lymph node diameter >10cm) to stage IV disease and deemed to require a full course of chemotherapy • ECOG performance status 0-2 • Adequate bone marrow function with platelets >100x109/L; neutrophils >1.0x109/L at study entry, unless lower figures are attributable to lymphoma. • Serum creatinine 3 months • Adequate contraceptive precautions for all patients of child bearing potential • A negative serum pregnancy test for females of child bearing potential or those =65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • 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. • Uncontrolled systemic infection • History of cardiac failure of uncontrolled angina • Clinical CNS involvement • Serological positivity for Hepatitis C, B or known HIV infection • Serious medical or psychiatric illness likely to affect participation or that may compromise the ability to give informed consent. • 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. • History of allergic reaction to substances containing boron or mannitol • Patient unwilling to abstain from green tea and preparations made from green tea as bortezomib may interact with these. • Any co-existing medical or psychological condition that would compromise ability to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary outcome measure is progression-free survival defined as the time from study registration to the date of progression or death from any cause. Analysis will be between R-CHOP and R-CHOP with bortezomib arms and between molecular phenotype of the lymphoma.;Main Objective: The primary objective of this trial is to demonstrate the efectiveness of bortezomib in combination with rituximab and CHOP chemotherapy (RB-CHOP) in comparison R-CHOP alone for the treatment of previously untreated patients with diffuse large B cell lymphoma. Efficacy will be determined by the number of patients who are alive and there condition has not progressed (Progression Free Survival). The study also will assess if the molecular profile (phenotype) (either ABC or GCB) determines the benefit from the addition of bortezomib.;Secondary Objective: There are a number of secondary objectives in this trial: 1. To compare the survival rate between the RB-CHOP and R-CHOP groups; to compare survival rate between ABC and GCB groups. 2. To compare the number of people living free from Lymphoma between both treatment and molecular groups. 3 To compare how long a patient responds to the treatement to the treatment between both treatment and molecular groups. 4 To compare overall response rate (ORR - including both partial and complete response) and complete response rate (CR) between both treatment groups 5 To assess differences in toxicity between assigned treatments 6 To assess quality of life and sid eeffects of the chemotherapy (in particular induced peripheral neuropathy) reported by patients across the two different treatments 7 To demonstrate that accurate molecular profiling may be conducted in real-time and relate these to immunohistochemical algorithms. 8 To perform exploratory analysis comparing aberrations in the NF-?B | — |
Countries
United Kingdom
Outcome results
None listed