Relapsed, or refractory mantle cell lymphoma MedDRA 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)
Conditions
Interventions
Trade Name: Velcade
Pharmaceutical Form:
Sponsors
Plymouth Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the rates of overall resonse (in terms of Complete response, Complete response (unconfirmed), and partial response); Secondary Objective: To evaluate the rates of complete response and complete response unconfirmed To determine the median time to progression To determine the median overall survival To evaluate the toxicity and tolerabilty of the two research treatments To compare the response rates with first line therapy To compare the quality of life between the two research treatments ; Primary end point(s): Disease progression Unacceptable toxicity/tolerability Patient withdrawal of consent | — |
Countries
United Kingdom
Outcome results
None listed