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 |
| Protocol serial number | Ply-26s |
| Sponsor | Plymouth Hospitals NHS Trust (UK) |
| Funder | Johnson and Johnson Pharmaceuticals (UK) |
- 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
Contact information
Dr Simon Rule
Scientific
Scientific
Department of Haematology
Level 07
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
| Phone | +44 (0)1752 517505 |
|---|---|
| none@example.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised open-label multicentre study, with a 1:1 randomisation between the two treatment groups |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Cyclophosphamide, adriamycin, vincristine and prednisolone (CHOP), bortezomib (Velcade®) |
| Primary outcome measure(s) | 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. |
| Key secondary outcome measure(s) | 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. |
| Completion date | 30/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 90 |
| 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
- United Kingdom
- England
Study participating centre
Department of Haematology
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 24/03/2022 | No | Yes | ||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/03/2022: Plain English results added.
