A randomised controlled, open label, phase II pilot study comparing the toxicity of rituximab plus CHOP chemotherapy with rituximab plus CHOP chemotherapy and bortezomib in adults with newly diagnosed diffuse large B-cell lymphoma (DLBCL) being treated in haemato-oncology units within South East Wales - R-CHOP vs R-CHOP plus bortezomib for DLBC

Phase 1

• Conditions: Diffuse large B-cell lymphoma; MedDRA version: 8.1Level: LLTClassification code 10012818Term: Diffuse large B-cell lymphoma

• Registration Number: EUCTR2006-003333-33-GB
• Lead Sponsor: Cardiff and Vale NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-07
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified