A Parallel Randomised Phase II Trial of CHOP Chemotherapy With or Without Bortezomib in Relapsed Mantle Cell Lymphoma - Bortezomib Study
- Conditions
- Relapsed, or refractory mantle cell lymphomaMedDRA version: 20.0 Level: PT Classification code 10026800 Term: Mantle cell lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2006-006090-24-GB
- Lead Sponsor
- Plymouth Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 46
Confirmed diagnosis of mantle cell lymphoma
Refractory to, or relapse or progression following completion of first-line anti-neoplastic therapy
Measurable disease
Karnofsky Performance status >50% (ECOG 0-2)
Toxic effects from previous therapy or surgery to be resolved to Grade 2 or better
Absolute neutrophil count >1000 ells/ul (not related to lymphoma)
Platelets >30,000 cells/ul
AST <3xULN, ALT<3xULN
Total bilirubin <2ULN
Calculated creatinine clearance >20ml/min
All chemotherapy regimens are permissible +/- Rituximab
Prior splenectomy or localised RT is permissible
Male and female patients aged 18 years or older
Written informed consent prior to any study related procedures
Where appropriate, patients to agree to take adequate methods of contraception for the duration of the study
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
Known serological positivity for HBV, HCV, HIV
Previous treatment with Velcade
Anti-neoplastic treatment within 3 weeks before Day 1 of cycle 1
Nitrosoureas within 6 weeks before Day 1 of cycle 1
Rituximab, alemtuzumab (Campath) or other unconjugated therapeutic antibody within 4 weeks before day 1 of Cycle 1
Radiation therapy within 3 weeks prior to Day 1 of Cycle 1
Major surgery within 2 weeks before Dat 1 of Cycle 1
History of allergic reaction attributable to compounds containing boron or mannitol
Female patients who may be pregnant or breast feeding
Active systemic infection requiring treatment
Diagnosed, or treated for, a malingancy other than MCL within 5 years before Day 1 of Cycle 1, with the exception of complete resection of basal cell carcinoma, squamous carcinoma of the skin, or any in-situ malignancy
Concurrent treatment with another investigational agent
Serious medical or psychiatric illness likely to interfere with participation in this study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the rates of overall resonse (in terms of Complete response, Complete response (unconfirmed), and partial response);<br> Secondary Objective: To evaluate the rates of complete response and complete response unconfirmed<br> To determine the median time to progression<br> To determine the median overall survival<br> To evaluate the toxicity and tolerabilty of the two research treatments<br> To compare the response rates with first line therapy<br> To compare the quality of life between the two research treatments<br> ;<br> Primary end point(s): Disease progression<br> Unacceptable toxicity/tolerability<br> Patient withdrawal of consent<br>
- Secondary Outcome Measures
Name Time Method