HOVON 127 BL
Research type
Research Study
Full title
Phase III study comparing R-CODOX-M/R-IVAC versus dose-adjusted EPOCH-R (DA-EPOCH-R) for patients with newly diagnosed high risk Burkitt lymphoma
IRAS ID
208868
Contact name
Sridhar Chaganti
Contact email
Sponsor organisation
HOVON Foundation
Eudract number
2013-004394-27
Clinicaltrials.gov Identifier
NTR4602, Nederlands Trial Register
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
This study is for patients who have Burkitt lymphoma. This is a cancer that causes the lymphocytes (a type of white blood cells involved in fighting infections) to grow abnormally. Burkitt lymphoma is a fast growing lymphoma. This means that it can usually be easily treated if chemotherapy is started immediately.
R-CODOX-M/R-IVAC is one of several standard treatment options for Burkitt lymphoma. These standard treatments have a cure rate of about 70%. The newer treatment being tested in this study is DA-EPOCH-R chemotherapy, a drug combination that might improve the cure rate. This treatment has already been tested in small groups of patients. The purpose of the study is to compare the two treatments (R-CODOX-M/R-IVAC and DA-EPOCH-R) to look at how patients respond to treatment and whether they have any side effects.
Patients will be randomly allocated to a treatment arm to receive either R-CODOX-M/R-IVAC treatment (treatment arm A) or DA-EPOCH-R treatment (treatment arm B). Both treatments will be administered by infusion into one of the larger blood vessels that are found just below the collarbone or in upper arm.
Patients randomised to treatment arm A will receive a cycle of R-CODOX-M followed by a cycle of R-IVAC. Both cycles will then be repeated once more. The cycles will be given approximately every four weeks. Patients will be admitted to the hospital for the treatment and will need to remain in hospital until their blood counts have recovered. After this it may be possible for patients to return home for a short time before the next cycle starts.
Patients randomised to treatment arm B will receive six cycles of DA-EPOCH-R. Each cycle will last five days. The next cycle will begin after at least twenty-one days, but the precise timing will depend on how well a patient’s blood counts recover. The medicines etoposide, doxorubicin and vincristine will be administered continuously through an infusion pump. All patients will be admitted to the hospital for five days during the first cycle. Some patients may be able to receive the remaining cycles at home, using a portable infusion pump. This will depend on the patient’s response to treatment and the facilities available at their hospital. If patients are able to receive outpatient DA-EPOCH-R they will still need to return to the hospital each day of the cycle to have a new bag of medicine attached to their pumps.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
18/EM/0085
Date of REC Opinion
12 Jun 2018
REC opinion
Further Information Favourable Opinion