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
Recruiting
- Conditions
- on-hodgkin lymphoma, Burkitt lymphomaBurkitt lymfoom
- Registration Number
- NL-OMON28081
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC Cancer Institute, Clinical Trial CenterP.O. Box 20403000 CA RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl
- Brief Summary
ot yet for this trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 260
Inclusion Criteria
First diagnosis of high risk Burkitt lymphoma (sporadic and
HIV associated), histologically confirmed according to the
WHO classification 2008. Upon its availability the WHO 2016
classification should be used, to replace the WHO 2008
classification;
Exclusion Criteria
- All histopathological diagnoses other than Burkitt
lymphoma according to the WHO classification 2008,
irrespective of the presence of a MYC rearrangement. Upon
its availability the WHO 2016 classification should be used, to
replace the WHO 2008 classification;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2 year PFS; defined as time from<br>randomisation to disease progression, relapse or death,<br>whichever comes first. Patients still alive or lost to follow<br>up are censored at the date they were last known to be alive.
- Secondary Outcome Measures
Name Time Method - ORR end-of-treatment<br /><br>- EFS and OS at 2 years<br /><br>- Rate of severe (CTCAE grade ≥3) toxicities<br /><br>- Number of hospitalisation days