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HOVON 127 BL / SAKK 37/16: 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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503423-25-00
Acronym
HOVON 127 BL
Enrollment
69
Registered
2024-09-11
Start date
2014-06-19
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Burkitt lymphoma

Brief summary

2-year PFS; defined as time from randomisation to disease progression, relapse or death, whichever comes first. Patients still alive or lost to follow up are censored at the date they were last known to be alive

Detailed description

ORR end-of-treatment, EFS at 2 years; defined as time from randomisation to first event (death from any cause, no CR, relapse, whichever comes first)., OS at 2 years; defined as time from randomisation until death from any cause; patients still alive or lost to follow up are censored at the date they were last known to be alive, Rate of CTCAE grade ≥3 toxicities, Number of hospitalization days

Interventions

DRUGMETHOTREXATE
DRUGIFOSFAMIDE
DRUGVINCRISTINE
DRUGCYCLOPHOSPHAMIDE
DRUGRITUXIMAB
DRUGETOPOSIDE
DRUGCYTARABINE
DRUGPREDNISOLONE
DRUGDOXORUBICIN

Sponsors

Haemato Oncology Foundation For Adults Netherlands
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
2-year PFS; defined as time from randomisation to disease progression, relapse or death, whichever comes first. Patients still alive or lost to follow up are censored at the date they were last known to be alive

Secondary

MeasureTime frame
ORR end-of-treatment, EFS at 2 years; defined as time from randomisation to first event (death from any cause, no CR, relapse, whichever comes first)., OS at 2 years; defined as time from randomisation until death from any cause; patients still alive or lost to follow up are censored at the date they were last known to be alive, Rate of CTCAE grade ≥3 toxicities, Number of hospitalization days

Countries

Belgium, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026