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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Department of Paediatrics
College of Medicine
University of Malawi
Blantyre
3
Malawi
Study information
| Study design | Interventional single centre non-randomised phase II study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/02/2006 |
| Completion date | 01/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 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
3
Malawi
Sponsor information
University of Malawi (Malawi)
University/education
University/education
College of Medicine
Chichiri
Blantyre
3
Malawi
| Website | http://www.medcol.mw/ |
|---|---|
"ROR" |
https://ror.org/04vtx5s55 |
Funders
Funder type
University/education
University of Birmingham (UK) - Division of Immunity and Infection
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
