Plain English Summary
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
Study website
Contact information
Type
Scientific
Contact name
Prof Mark Drayson
ORCID ID
Contact details
Clinical Immunology Service
Institute of Immunology and Immunotherapy
Medical School
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 4069
m.t.drayson@bham.ac.uk
Type
Scientific
Contact name
Dr George Chagaluka
ORCID ID
Contact details
The Paediatric Department
Queen Elizabeth Central Hospital
Blantyre
Box 95
Malawi
Type
Scientific
Contact name
Prof Elizabeth Molyneux
ORCID ID
Contact details
The Paediatric Department
Queen Elizabeth Central Hospital
Blantyre
Box 95
Malawi
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
National Health Sciences Research NHSRC #15/5ll28l
Study information
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
Acronym
RIBULY
Study hypothesis
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
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
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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)
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
Overall study end date
01/03/2024
Reason abandoned (if study stopped)
Eligibility
Participant 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
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
220
Participant 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
Recruitment start date
20/06/2016
Recruitment end date
01/03/2023
Locations
Countries of recruitment
Malawi
Study participating centre
Queen Elizabeth Central Hospital
Paediatric Department
Blantyre
PO Box 95
Malawi
Sponsor information
Organisation
University of Malawi College of Medicine
Sponsor details
Private Bag 360
Chichiri
Blantyre
Box 3
Malawi
+265 (0)1 871 911
registrar@medcol.mw
Sponsor type
University/education
Website
http://www.medcol.mw/contact-us/
ROR
Funders
Funder type
University/education
Funder name
Alumni of University of Birmingham, UK
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Scott Hampton Foundation for Burkitt's Research
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
30/11/2024
Individual participant data (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.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|