Contact information
Type
Scientific
Primary contact
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
0121 414 4069
m.t.drayson@bham.ac.uk
Type
Scientific
Additional contact
Dr George Chagaluka
ORCID ID
Contact details
The Paediatric Department
Queen Elizabeth Central Hospital
Blantyre
Box 95
Malawi
Type
Scientific
Additional contact
Prof Elizabeth Molyneux
ORCID ID
Contact details
The Paediatric Department
Queen Elizabeth Central Hospital
Blantyre
Box 95
Malawi
Additional identifiers
EudraCT 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
National Health Sciences Research Committee, Ministry Of Health, Lilongwe 3, Malawi, 12/06/2015, ref: NHSRC #15/5ll28l
Study design
An open-label, randomised, phase 2 study of rituximab as adjunctive therapy in the treatment of Burkitt’s lymphoma at QECH, Blantyre, Malawi.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
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
Biological/Vaccine
Phase
Drug names
Primary outcome measures
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 trial start date
20/06/2016
Overall trial end date
31/05/2020
Reason abandoned
Eligibility
Participant inclusion criteria
1. The child will be <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
Patient
Age group
Child
Gender
Both
Target number of participants
A total of 180 cases are expected to be enrolled in 3 yrs
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
01/06/2019
Locations
Countries of recruitment
Malawi
Trial participating centre
Paediatric Department, Queen Elizabeth Central Hospital
PO Box 95
Blantyre
PO Box 95
Malawi
Sponsor information
Organisation
University of Malawi College of Medicine
Sponsor details
University of Malawi
College of Malawi
Private Bag 360. Chichiri
Blantyre
Box 3
Malawi
+265-1-871-911
registrar@medcol.mw
Sponsor type
University/education
Website
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
31/05/2021
Participant level data
Not expected to be available
Results - basic reporting
Publication summary