Rituximab adjunctive therapy for Burkitt's lymphoma
| ISRCTN | ISRCTN90296187 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90296187 |
| Secondary identifying numbers | National Health Sciences Research NHSRC #15/5ll28l |
- Submission date
- 25/05/2016
- Registration date
- 17/06/2016
- Last edited
- 15/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Burkitt’s lymphoma is an uncommon form of non-Hodgkin lymphoma. It is a cancer that affects a type of white blood cells called lymphocytes. The aim of this study is to find out whether the addition of a single dose of the drug rituximab to standard anti-lymphoma treatment will improve outcomes in Burkitt's lymphoma, relapsed and resistant.
Who can participate?
Children aged under 14 with Burkitt's lymphoma
What does the study involve?
All patients receive the standard treatment for Burkitt's lymphoma and are randomly allocated into three groups. Group One receives one additional dose of 375mg/m2 of rituximab on Day 15. Group Two receives one additional dose of 50mg/m2 of rituximab on Day 15. Group Three receives no additional rituximab. The three groups are compared for the number of children in clinical complete remission at the end of chemotherapy and 1 year later.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Queen Elizabeth Central Hospital (Malawi)
When is the study starting and how long is it expected to run for?
June 2016 to March 2024
Who is funding the study?
1. Alumni of University of Birmingham (UK)
2. The Scott Hampton Foundation for Burkitt's Research (UK)
Who is the main contact?
Prof. Mark Drayson
m.t.drayson@bham.ac.uk
Contact information
Scientific
Clinical Immunology Service
Institute of Immunology and Immunotherapy
Medical School
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 4069 |
|---|---|
| m.t.drayson@bham.ac.uk |
Scientific
The Paediatric Department
Queen Elizabeth Central Hospital
Blantyre
Box 95
Malawi
Scientific
The Paediatric Department
Queen Elizabeth Central Hospital
Blantyre
Box 95
Malawi
Study information
| Study design | Open-label randomised phase II study |
|---|---|
| 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 to request a patient information sheet |
| Scientific title | An open-label, randomised, phase 2 study of rituximab as adjunctive therapy in the treatment of Burkitt’s lymphoma at QECH, Blantyre, Malawi |
| Study acronym | RIBULY |
| Study objectives | Addition of rituximab to standard anti-lymphoma therapy will improve outcome in newly diagnosed, relapsed and resistant Burkitt's Lymphoma. |
| Ethics approval(s) | National Health Sciences Research Committee, Ministry Of Health, Lilongwe 3, Malawi, 12/06/2015, ref: NHSRC #15/5ll28l |
| Health condition(s) or problem(s) studied | Burkitt's lymphoma |
| Intervention | This study tests whether the addition of a single dose of rituximab to standard anti-lymphoma therapy will improve outcome in newly diagnosed, relapsed and resistant eBL. All patients will receive the standard therapy for Burkitt's lymphoma and will be randomised into 3 groups: Group One will receive 1 additional dose of 375mg/m2 of rituximab on Day 15 Group Two will receive 1 additional dose of 50mg/m2 of rituximab on Day 15 Group Three will receive no additional rituximab The study will compare between these three groups for the number of children in Clinical Complete Remission at the end of chemotherapy and a year later. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Not provided at time of registration |
| Primary outcome measure | Clinical Complete Remission rate at end of chemotherapy |
| Secondary outcome measures | 1. Clinical Complete Remission rate at one year post chemotherapy 2. Severe adverse effects of rituximab |
| Overall study start date | 20/06/2016 |
| Completion date | 01/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | A total of 180 cases are expected to be enrolled in 3 yrs |
| Total final enrolment | 293 |
| Key inclusion criteria | 1. Child <14 yrs of age with proven Burkitt's lymphoma (BL) or relapse or resistant BL 2. After full information, the guardians have given written informed consent, and the child if appropriate will be asked for assent 3. The guardian and patient will be willing and able to complete treatment and follow-up |
| Key exclusion criteria | 1. Patients known to be allergic to trial medications 2. Patients or their guardians who do not consent 3. Pregnant and/or breastfeeding patients |
| Date of first enrolment | 20/06/2016 |
| Date of final enrolment | 01/03/2023 |
Locations
Countries of recruitment
- Malawi
Study participating centre
Blantyre
PO Box 95
Malawi
Sponsor information
University/education
Private Bag 360
Chichiri
Blantyre
Box 3
Malawi
| Phone | +265 (0)1 871 911 |
|---|---|
| registrar@medcol.mw | |
| Website | http://www.medcol.mw/contact-us/ |
"ROR" |
https://ror.org/04vtx5s55 |
Funders
Funder type
University/education
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the TMG. Summary data including baseline characteristics and outcome data will be available after the primary publication for up to 5 years from the end of the study. Data will be shared with any researchers for whom the scope and purpose of the data sharing are agreed by the TMG, all participants have agreed to use of data for research, no identifiable data will be released and patients will have a unique trial number assigned. The researchers encourage data sharing and all reasonable requests will be reviewed favourably. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 20/10/2024 | 15/11/2024 | No | No |
Additional files
Editorial Notes
15/11/2024: The following changes were made to the trial record:
1. The total final enrolment was changed from 220 to 293.
2. Publication reference added.
11/05/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/06/2019 to 01/03/2023.
2. The overall trial end date has been changed from 31/05/2022 to 01/03/2024 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 30/11/2022 to 30/11/2024.
06/05/2021: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/05/2020 to 31/05/2022.
2. The intention to publish date was changed from 31/05/2021 to 30/11/2022.
3. The total final enrolment number and IPD sharing statement were added.
22/02/2018: Plain English summary added.
