CHOP Velcade in Mantle Cell

A Parallel Randomised Phase II Trial Of CHOP Chemotherapy With Or Without Bortezomib In Relapsed Mantle Cell Lymphoma

• Male and female subjects 18 years and older

• 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)

• Refractory to, or relapse, or progression following completion of first line anti-neoplastic therapy

• All chemotherapy regimens are permissible and can have been given in combination with Rituximab

• Prior splenectomy or localised radiotherapy is permissible

• Measurable disease

• Karnofsky Performance Status ≥50%, ECOG 0-2 (Protocol version 3, 19th February 2008)

• Absolute neutrophil count ≥1000 cells/μL not related to lymphoma

• Platelets ≥30,000 cells/μL

• Aspartate transaminase ≤3 x upper limit of normal (ULN), alanine transaminase ≤3 x ULN, total bilirubin ≤2 x ULN, and calculated creatinine clearance ≥20 mL/min

• Toxic effects of previous therapy or surgery resolved to Grade 2 or better

• Female subject is either post-menopausal or surgically sterilised or willing to use an acceptable method of birth control

• Male subject agrees to use an acceptable method for contraception for the duration of the study

• 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at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

• Known serological positivity for HBV, HCV or HIV

• Previous treatment with Velcade

• Anti-neoplastic therapy 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 before Day 1 of Cycle 1

• Major surgery within 2 weeks before Day 1 of Cycle 1

• History of allergic reaction attributable to compounds containing boron or mannitol

• Diagnosed or treated for a malignancy other than MCL within 5 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

• Active systemic infection requiring treatment

• Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy
test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilised women

• Serious medical or psychiatric illness likely to interfere with participation in this clinical study

• Concurrent treatment with another investigational agent. Concurrent participation in nontreatment studies is allowed, if it does not interfere with participation in this study

Principal Investiagtor

Dr Rod Johnson

Tel 0113 2068369

Email rod.johnson@leedsth.nhs.uk

Research Nurse

Julie Bagabag

Tel 0113 2068577

Email julie.bagabag@leedsth.nhs.uk

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