Non-hodgkin lymphoma, Burkitt lymphoma Burkitt lymfoom
Conditions
Interventions
Arm A: R-CODOX-M/R-IVAC
2 cycles of R-CODOX-M and 2 cycles R-IVAC
(alternately) total of 16 weeks (4 weeks per cycle)
R-CODOX-M consists of:
- rituximab i.v. (day 1,9: 375 mg/m^2/d)
- cyclophosph
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
P/a HOVON Data Center
Erasmus MC Cancer Institute, Clinical Trial Center
P.O. Box 2040
3000 CA Rotterdam
Tel: 010 4391568
Fax: 010 4391028
e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
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; - High risk disease; i.e. any of following: elevated LDH, WHO performance status ≥ 2, Ann Arbor stage III or IV, tumour mass ≥ 10 cm; - Age 18-75 years inclusive; - WHO performance status (PS) 0-3, WHO PS 4 only if disease related; - Written informed consent.
Exclusion criteria
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; - Patients with endemic Burkitt lymphoma; - Patients with low risk Burkitt lymphoma (i.e. all of following: normal LDH, WHO performance status 0 or 1, Ann Arbor stage I or II, no tumour mass ≥ 10 cm); - Patients with CNS localisation of Burkitt lymphoma; - Prior treatment other than local radiation (max. 10 Gy) or short course (max 7 days) of steroids ≤ 1 mg/kg or ≤100mg prednisolone (whichever is greater; or equivalent corticosteroid) for acute symptoms; - Creatinine clearance 2.5 * ULN (total) except patients with Gilbert’s syndrome as defined by > 80% unconjugated; - Inadequate haematological function ANC < 1x10^9/l and platelets < 75x10^9 /l unless lymphoma related; - Severe pulmonary dysfunction (CTCAE grade 3-4); - Severe neurological or psychiatric disease; - Active symptomatic ischemic heart disease, myocardial infarction, or congestive heart failure within the past year. If an ultrasound or MUGA scan is obtained the LVEF should exceed 45%; - All men and all women of child-bearing potential not willing or able to use an acceptable method of birth control for the duration of the study and one year beyond treatment completion; - Female subject pregnant or breast-feeding; - History of a prior invasive malignancy in the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma; - Serious concomitant medical illnesses that would jeopardise the patient's ability to receive the regimen with reasonable safety, including active hepatitis B (HBV) or hepatitis C (HCV) infection; - Current participation in another clinical trial if interfering with HO127; - Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Design outcomes
Primary
| Measure | Time 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
| Measure | Time frame |
|---|---|
| - ORR end-of-treatment - EFS and OS at 2 years - Rate of severe (CTCAE grade ≥3) toxicities - Number of hospitalisation days | — |
Contacts
Public ContactM.E.D. Chamuleau
VU University Medical Center Dpt of Hematology De Boelelaan 1117
Outcome results
None listed