Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
That patients with relapsed Burkitt's lymphoma will respond to adjunctive therapy with bezafibrate and medroxyprogesterone acetate.
Ethics approval
University of Malawi College of Medicine Research and Ethics Committee, 01/11/2005, ref: COMREC P/05/06/467
Study design
Interventional single centre non-randomised phase II study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Bezafibrate, medroxyprogesterone acetate
Primary outcome measure
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
Secondary outcome measures
1. Response to therapy
2. Disease-free survival
3. Overall survival
Follow-up to a minimum of a year.
Overall trial start date
01/02/2006
Overall trial end date
01/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/02/2006
Recruitment end date
01/12/2009
Locations
Countries of recruitment
Malawi
Trial participating centre
Department of Paediatrics,
Blantyre
3
Malawi
Sponsor information
Organisation
University of Malawi (Malawi)
Sponsor details
College of Medicine
Chichiri
Blantyre
3
Malawi
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Birmingham (UK) - Division of Immunity and Infection
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24266453
Publication citations
-
Results
Molyneux E, Merrick B, Khanim FL, Banda K, Dunn JA, Iqbal G, Bunce CM, Drayson MT, Bezafibrate and medroxyprogesterone acetate in resistant and relapsed endemic Burkitt lymphoma in Malawi; an open-label, single-arm, phase 2 study (ISRCTN34303497)., Br. J. Haematol., 2014, 164, 6, 888-890, doi: 10.1111/bjh.12681.