Condition category
Cancer
Date applied
18/03/2008
Date assigned
16/05/2008
Last edited
20/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Simon Rule

ORCID ID

Contact details

Department of Haematology
Level 07
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
+44 (0)1752 517505

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Ply-26s

Study information

Scientific title

Acronym

Bortezomib Study

Study hypothesis

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

Cornwall and Plymouth Research Ethics Committee on 23/02/2007 (ref: 07/Q2103/7)

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase II

Drug names

Cyclophosphamide, adriamycin, vincristine and prednisolone (CHOP), bortezomib (Velcade®)

Primary outcome measures

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 trial start date

01/06/2007

Overall trial end date

30/04/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90 patients

Participant 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.

Recruitment start date

01/06/2007

Recruitment end date

30/04/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Haematology
Plymouth
PL6 8DH
United Kingdom

Sponsor information

Organisation

Plymouth Hospitals NHS Trust (UK)

Sponsor details

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

Sponsor type

Government

Website

http://www.plymouthhospitals.nhs.uk/Pages/Home.aspx

Funders

Funder type

Industry

Funder name

Johnson and Johnson Pharmaceuticals (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes