Relapsed / Refractory Mantle Cell Lymphoma MedDRA version: 14.1 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
Sponsors
Plymouth Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients 18 years and older A confirmed mantle cell lymphoma which is refractory to, or relapsed following the completion of 2 or more anti-neoplastic therapies - All chemotherapy regimens are permissible Measrable disease Karnofsky Performance Status >/= 50% (ECOG 0-2) Absolute neutrophil count of >/= 1000 cells/uL, not related to lymphoma Platelets >/= 30,000 cells/uL Aspartate transaminase =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients known to be serologically positive for HBV, HCV or HIV Previous treatment with lenalidomide Any anti-neoplastic therapy within 3 weeks prior to Day 1 of Cycle 1 Any nitrosoureas within 6 weeks prior to Day 1 of Cycle 1 Treatment with Rituximab, Alemtuzumab or other unconjugated therapeutic antibody within 4 weeks prior to Day 1 of Cycle 1 Radiation therapy within 3 weeks before Day 1 of Cycle 1 Major surgery within 2 weeks prior to Day 1 of Cycle 1 Active systemic infection requiring treatment Any concurrent active malignancy female patients who may be pregnant or breast-feeding Serious medical or psychiatric illness likely to interfere with participation in this study Concurrent treatment with another investigational agent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the rates of overall response to lenalidomide in terms of complete response, complete response unconfirmed and partial response;Secondary Objective: To evaluate the duration of response To determine the median time to progression To determine the median overall survival To evaluate the toxicity and tolerability of the research treatment;Primary end point(s): Disease progression Unacceptable toxicity or tolerability Patients withdarawl of consent | — |
Countries
United Kingdom
Outcome results
None listed