Non-randomised trial of a lipid lowering drug and a steroid for the treatment of relapsed Burkitt's lymphoma in Blantyre, Malawi

ISRCTN	ISRCTN34303497
DOI	https://doi.org/10.1186/ISRCTN34303497
Protocol serial number	N/A
Sponsor	University of Malawi (Malawi)
Funder	University of Birmingham (UK) - Division of Immunity and Infection

Submission date: 24/12/2008
Registration date: 23/01/2009
Last edited: 03/07/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Elizabeth Molyneux
Scientific

Department of Paediatrics
College of Medicine
University of Malawi
Blantyre
3
Malawi

Study information

Primary study design	Interventional
Study design	Interventional single centre non-randomised phase II study
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title	A phase II non-randomised study of medroxyprogesterone acetate plus bezafibrate as adjunctive therapy in the treatment of relapsed Burkitt's lymphoma in Blantyre, Malawi
Study objectives	That patients with relapsed Burkitt's lymphoma will respond to adjunctive therapy with bezafibrate and medroxyprogesterone acetate.
Ethics approval(s)	University of Malawi College of Medicine Research and Ethics Committee, 01/11/2005, ref: COMREC P/05/06/467
Health condition(s) or problem(s) studied	Burkitt's lymphoma
Intervention	The trial drugs are given orally, daily for 6 weeks: 1. Medroxprogesterone acetate 4 mg/kg twice daily 2. Bezafibrate 200 mg daily or twice daily if weight greater than 20 kg For participants 21 - 30 the trial drugs doses are increased to: 1. Medroxyprogesterone acetate 20 mg/kg once daily 2. Bezalip Mono one 400 mg tablet/10 kg body weight daily For participants 31 - 40 the trial drugs doses are increased to: 1. Medroxyprogesterone acetate 20 mg/kg once daily 2. Bezalip Mono two 400 mg tablets/10 kg body weight daily All patients will receive standard anti-Burkitt's lymphoma therapy with cyclophosphamide, vincristine and intrathecal methotrexate/hydrocortisone starting the first day of the second week.
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	Bezafibrate, medroxyprogesterone acetate
Primary outcome measure(s)	1. Response of Burkitt's lymphoma in the first week of trial therapy 2. Adverse events attributable to the trial drugs medroxyprogesterone acetate and bezafibrate
Key secondary outcome measure(s)	1. Response to therapy 2. Disease-free survival 3. Overall survival Follow-up to a minimum of a year.
Completion date	01/12/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	14 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Aged less than 14 years, either sex 2. Diagnosis of relapsed Burkitt's lymphoma confirmed by cytology/immunophenotyping 3. Negative pregnancy test if the patient is of childbearing potential 4. Informed consent, and the ability of the guardian and patient to co-operate with treatment and follow up must be ensured and documented
Key exclusion criteria	1. Patient unable to swallow tablets 2. Patients living outside Malawi (follow up is not possible for patients living in Mozambique) 3. Pregnancy 4. Breast feeding
Date of first enrolment	01/02/2006
Date of final enrolment	01/12/2009

Locations

Countries of recruitment

Malawi

Study participating centre

Department of Paediatrics,

Blantyre
3
Malawi

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes