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
Description
Design:
HOVON 127 BL is a randomized, open-label, prospective, multicentre phase III study. All eligible patients will be randomized to receive either R-CODOX-M/R-IVAC or DA-EPOCH-R.
Treatment:
Patients will receive 6 cycles of DA-EPOCH-R or 2 cycles of R-CODOX-M alternated with 2 cycles of R-IVAC. All patients will receive prophylactic intrathecal treatment and supportive care.
Key inclusion/exclusion criteria:
Patients must have a first diagnosis of high-risk Burkitt lymphoma (sporadic or HIV-associated). Patients with endemic or low-risk Burkitt lymphoma are excluded, as are any patients who have had prior treatment other than local radiation or a short-course of steroids.
Duration of recruitment:
4 to 5 years.
Aim
The overall aim of this study is to confirm in a multicentre setting and improvement in PFS to 85% at 2 years of DA-EPOCH-R in patients with newly diagnosed high-risk Burkitt lymphoma, compared to 2 year PFS of 70% for the control treatment, R-CODOX-M/R-IVAC. Both regimens will also be evaluated with respect to toxicity and hospitalisation days.