Relapsed or refractory mantle cell lymphoma Cancer Mantle cell lymphoma
Conditions
Interventions
There are two treatment groups in this study. Both use the CHOP chemotherapy regimen as described below. One group of patients will receive this regimen alone, and the other will receive the same dose
Sponsors
Plymouth Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects 18 years and older 2. A confirmed diagnosis of MCL including expression of cyclin D1 or evidence of t(11;14), such as by cytogenetics, fluorescent in situ hybridisation (FISH) or polymerase chain reaction (PCR) 3. Refractory to, or relapse, or progression following completion of first line anti-neoplastic therapy 4. All chemotherapy regimens are permissible and can be given in combination with rituximab 5. Prior splenectomy or localised radiotherapy is permissible 6. Measurable disease 7. Karnofsky Performance Status (KPS) greater than 50% (Eastern Cooperative Oncology Group [ECOG] grade 0 - 2) 8. Absolute neutrophil count greater than 1000 cells/mcg not related to lymphoma 9. Platelets greater than 30,000 cells/mcg 10. Aspartate transaminase less than 3 x upper limit of normal (ULN), alanine transaminase less than 3 x ULN, total bilirubin less than 2 x ULN, and calculated creatinine clearance greater than 20 mL/min 11. Toxic effects of previous therapy or surgery resolved to grade 2 or better 12. Female subject is either post-menopausal or surgically sterilised or willing to use an acceptable method of birth control 13. Male subject agrees to use an acceptable method for contraception for the duration of the study 14. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Exclusion criteria
Exclusion criteria: 1. Known serological positivity for hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) 2. Previous treatment with Velcade® 3. Anti-neoplastic therapy within three weeks before day 1 of cycle 1 4. Nitrosoureas within six weeks before day 1 of cycle 1 5. Rituximab, alemtuzumab (Campath®) or other unconjugated therapeutic antibody within four weeks before day 1 of cycle 1 6. Radiation therapy within three weeks before day 1 of cycle 1 7. Major surgery within two weeks before day 1 of cycle 1 8. History of allergic reaction attributable to compounds containing boron or mannitol 9. Diagnosed or treated for a malignancy other than MCL within five years before day 1 of cycle 1, with the exception of complete resection of basal cell carcinoma, squamous cell carcinoma of the skin, or any in situ malignancy 10. Active systemic infection requiring treatment 11. Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilised women. 12. Serious medical or psychiatric illness likely to interfere with participation in this clinical study 13. Concurrent treatment with another investigational agent. Concurrent participation in non-treatment studies is allowed, if it does not interfere with participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to the treatment(s) in terms of complete response, and partial response. As these outcomes will be measured until the patient relapses or progresses, the exact timepoints of the outcomes cannot be given precise times. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of response to treatment 2. Time to progression 3. Overall survival rates 4. Toxicity As these outcomes will be measured until the patient relapses or progresses, the exact timepoints of the outcomes cannot be given precise times. | — |
Countries
England, United Kingdom
Outcome results
None listed