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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 90

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 (Appendix A), 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

- 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 localization of Burkitt lymphoma;
- Prior treatment other than local radiation (max. 10 Gy) or short course (max
7 days) of steroids <= 1 mg/kg for acute symptoms; or <= 100 mg prednisolone
(whichever is greater; or equivalent corticosteroid), or 1 cycle of R-CHOP
- Creatinine clearance < 50 ml/min unless lymphoma related;
- Inadequate hepatic function: bilirubin > 2.5 * ULN (total) except patients
with Gilbert*s syndrome as defined by > 80% unconjugated;
- Inadequate heamatological function ANC < 1x109/l and platelets < 75x109 /l
unless lymphoma related;
- Severe pulmonary dysfunction (CTCAE grade 3-4, see appendix D);
- 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 jeopardize the patient's
ability to receive the regimen with reasonable safety, including active
hepatitis B (HBV, see also paragraph 9.3) 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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