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: Authorised-recruitment may be ongoing or finished

Sex: All

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;
• 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 195
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

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 acute symptoms;
• 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, or active viralhepatitis;
• 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 jeopardize the patient's ability to receive the regimen with reasonable safety, includig active HBV infection;
• Current participation in another clinical trial;
• Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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