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Register:	ISRCTN
Last refreshed on:	23 May 2022
Main ID:	ISRCTN90296187
Date of registration:	17/06/2016
Prospective Registration:	Yes
Primary sponsor:	University of Malawi College of Medicine
Public title:	Rituximab adjunctive therapy for Burkitt's lymphoma
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
Date of first enrolment:	20/06/2016
Target sample size:	180
Recruitment status:	Ongoing
URL:	https://www.isrctn.com/ISRCTN90296187
Study type:	Interventional
Study design:	Open-label randomised phase II study (Treatment)
Phase:	Phase II

Countries of recruitment
Malawi

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Mark Drayson
Address:	Clinical Immunology Service Institute of Immunology and Immunotherapy Medical School University of Birmingham Edgbaston B15 2TT Birmingham United Kingdom
Telephone:	+44 (0)121 414 4069
Email:	m.t.drayson@bham.ac.uk
Affiliation:

Key inclusion & exclusion criteria

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

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Burkitt's lymphoma
Cancer

Intervention(s)

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.

Primary Outcome(s)

Clinical Complete Remission rate at end of chemotherapy

Secondary Outcome(s)

1. Clinical Complete Remission rate at one year post chemotherapy
2. Severe adverse effects of rituximab

Secondary ID(s)

National Health Sciences Research NHSRC #15/5ll28l

Source(s) of Monetary Support

Alumni of University of Birmingham, UK, The Scott Hampton Foundation for Burkitt's Research

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

National Health Sciences Research Committee, Ministry Of Health, Lilongwe 3, Malawi, 12/06/2015, ref: NHSRC #15/5ll28l

Results

Results available:	Yes
Date Posted:
Date Completed:	01/03/2024
URL:

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