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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
EU CTIS ID: 2023-503423-25-00
What this study is testing
To confirm in a multicenter setting an improvement in PFS to 85% at 2 years of DA-EPOCH-R in patients with newly diagnosed high risk Burkitt lymphoma as compared to an expected PFS of 70% at 2 years for the control arm R-CODOX-M/R-IVAC
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
- 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
See the full eligibility 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
- 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
- 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 hepatitis B (HBV, see also paragraph 9.3) or hepatitis C (HCV) infection
- Current participation in another clinical trial interfering with HO127
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- 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
- 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
- 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
- Severe pulmonary dysfunction (CTCAE grade 3-4, see Appendix D)
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.