A trial of bortezomib with R-CHOP for diffuse large B cell lymphoma (DLBCL)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 940

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 <150µmol/L, serum bilirubin <35µmol/L and transaminases <2.5x upper limit of normal at the time of study entry, unless attributable to lymphoma. • Cardiac function sufficient to tolerate 300mg/m2 of doxorubicin. A pre-treatment echocardiogram is not mandated, but recommended in patients considered at higher risk of anthracycline cardiotoxicity. • No concurrent uncontrolled medical condition. • Life expectancy >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 <2 years after the onset of the menopause • Patients will have provided written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

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.