A parallel randomised phase II trial of cyclophosphamide, adriamycin, vincristine and prednisolone (CHOP) chemotherapy with or without Bortezomib in relapsed mantle cell lymphoma

ISRCTN	ISRCTN20159589
DOI	https://doi.org/10.1186/ISRCTN20159589
Secondary identifying numbers	Ply-26s

Submission date: 18/03/2008
Registration date: 16/05/2008
Last edited: 24/03/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-chop-chemotherapy-with-or-without-bortezomib-for-relapsed-mantle-cell-lymphoma

Study website

Contact information

Dr Simon Rule
Scientific

Department of Haematology
Level 07
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom

Phone	+44 (0)1752 517505
Email	none@example.com

Study information

Study design	Randomised open-label multicentre study, with a 1:1 randomisation between the two treatment groups
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A parallel randomised phase II trial of cyclophosphamide, adriamycin, vincristine and prednisolone (CHOP) chemotherapy with or without Bortezomib in relapsed mantle cell lymphoma
Study acronym	Bortezomib Study
Study objectives	The addition of bortezomib to cyclophosphamide, adriamycin, vincristine and prednisolone (CHOP) chemotherapy will improve the response rates and the duration of these responses in patients with relapsed mantle cell lymphoma (MCL), when compared to CHOP chemotherapy alone. As of 17/02/2011 the anticipated end date for this trial has been updated from 28/02/2010 to 30/04/2011.
Ethics approval(s)	Cornwall and Plymouth Research Ethics Committee on 23/02/2007 (ref: 07/Q2103/7)
Health condition(s) or problem(s) studied	Relapsed or refractory mantle cell lymphoma
Intervention	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 and schedule, with the addition of bortezomib (Velcade®): CHOP alone: The following CHOP regimen will be given on a 21-day cycle for a maximum of eight cycles: Day 1: Doxorubicin 50 mg/m^2 intravenous (IV) Day 1: Cyclophosphamide 750 mg/m^2 IV Day 1: Vincristine 1.4 mg/m^2 (maximum dose of 2 mg) IV Days 1 - 5: Prednisolone 100 mg orally CHOP and bortezomib (Velcade®): The following CHOP and bortezomib regimen will be given on a 21 day cycle for a maximum of eight cycles: Day 1: Bortezomib 1.6 mg/m^2 given as 3 - 5 second IV push Day 1: Doxorubicin 50 mg/m^2 IV Day 1: Cyclophosphamide 750 mg/m^2 IV Day 1: Vincristine 1.4 mg/m^2 (maximum dose of 2 mg) IV Days 1 - 5: Prednisolone 100 mg orally Day 8: Bortezomib 1.6 mg/m^2 given as 3 - 5 second IV push Patients will be followed up until death.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Cyclophosphamide, adriamycin, vincristine and prednisolone (CHOP), bortezomib (Velcade®)
Primary outcome measure	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 outcome measures	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.
Overall study start date	01/06/2007
Completion date	30/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	90 patients
Key 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
Key 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.
Date of first enrolment	01/06/2007
Date of final enrolment	30/04/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Haematology

Plymouth
PL6 8DH
United Kingdom

Sponsor information

Plymouth Hospitals NHS Trust (UK)
Hospital/treatment centre

Research and Development Office
Room N17
ITTC Building
Tamar Science Park
Derriford
Plymouth
PL6 8BX
England
United Kingdom

Website	http://www.plymouthhospitals.nhs.uk/Pages/Home.aspx
"ROR"	https://ror.org/05x3jck08

Funders

Funder type

Industry

Johnson and Johnson Pharmaceuticals (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results			24/03/2022	No	Yes

Editorial Notes

24/03/2022: Plain English results added.