HOVON 127 BL / SAKK 37/16: Phase III study comparing 2 treatments (R-CODOX-M/R-IVAC versus DA-EPOCH-R) in patients with Burkitt lymphoma

Ki vehet részt

• 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 (appendix C), 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 (Appendix C)
• Written informed consent

Ki nem vehet részt

• Serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety, includig active hepatitis B (HBV, see also paragraph 9.3) or hepatitis C (HCV) infection
• Prior treatment other than local radiation (max. 10 Gy) or short course (max 7 days) of steroids ≤ 1 mg/kg or ≤100mg predniso(lo)ne (whichever is greater; or equivalent corticosteroid) or acute symptoms; or 1 cycle of R-CHOP
• Severe neurological or psychiatric disease
• 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
• Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• 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%
• 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 haematological function ANC < 1x10^9/l and platelets < 75x10^9 /l unless lymphoma related
• 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
• 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
• Current participation in another clinical trial interfering with HO127
• Patients with endemic Burkitt lymphoma
• Patients with low risk Burkitt lymphoma (i.e. all of following: normal LDH, WHO performance status 0 or 1 (appendix C), Ann Arbor stage I or II (Appendix A), no tumour mass ≥ 10 cm)
• Patients with CNS localization of Burkitt lymphoma
• Severe pulmonary dysfunction (CTCAE grade 3-4, see Appendix D)