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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN34303497

Enrollment

Registered

2009-01-23

Start date

2006-02-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burkitt's lymphoma Cancer Diffuse non-Hodgkin's lymphoma

Interventions

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 - 3

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Response to therapy 2. Disease-free survival 3. Overall survival Follow-up to a minimum of a year.	—

Countries

Malawi

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026