Condition category
Cancer
Date applied
24/12/2008
Date assigned
23/01/2009
Last edited
03/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Elizabeth Molyneux

ORCID ID

Contact details

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

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 measures

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

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

http://www.medcol.mw/

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24266453

Publication citations

  1. 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.

Additional files

Editorial Notes