Content - HOVON 127 / SAKK 37/16

HOVON 127 / SAKK 37/16 – Optimization of chemotherapy for Burkitt lymphoma

In this study, SAKK and the Haemato Oncology Foundation for Adults in the Netherlands (HOVON) are comparing two different chemotherapies for patients with newly diagnosed Burkitt lymphoma. Burkitt lymphoma is a malignant lymphoma that is classified as a high-risk tumour, i.e. it has characteristics indicative of rapid growth and rapid deterioration of the patient’s condition. The aim of this study is to improve the treatment outcome and tolerability of chemotherapy for this disease.

Patients will be assigned to one of two groups on a random basis (randomized study). Randomized studies are an internationally recognized method that enables scientific comparison of treatments. One group of patients will be treated with the current therapeutic standard R-CODOX-M/R-IVAC, while the second group will be given a combination of medicinal products using the DA-EPOCH-R protocol. Both are internationally recognized therapies for this disease, yet in an earlier study DA-EPOCH-R was found to be more effective and associated with a lower mortality rate than treatment with R-CODOX-M/R-IVAC. This international study seeks to confirm this finding on a larger scale (260 patients).

Patients will participate in the study for a total period of 16-18 weeks, after which there will be follow-up examinations for a further five years. All the medicinal products used in this study are authorized in Europe and Switzerland.

Study chair:

Prof. Dr. med. Frank Stenner, University Hospital Basel, +41 61 265 50 74

  • 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 (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.
  • 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 (appendix C), Ann Arbor stage I or II (Appendix A), 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 < 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 < 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 jeopardise 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.

Locations for this trial:

Universitätsspital Basel
Petersgraben 4
0 4031 Basel