Condition category
Cancer
Date applied
25/05/2016
Date assigned
17/06/2016
Last edited
22/02/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 May 2020

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

Trial website

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
+44 (0)121 414 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

Open-label randomised phase II study

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 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

Phase

Phase II

Drug names

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 trial start date

20/06/2016

Overall trial end date

31/05/2020

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

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

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/

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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/02/2018: Plain English summary added.