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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 127 BL

1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms

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HO127 news

 01-12-2017: De reportage van de Safety formulieren in de HO127 studie zijn veranderd. Vanaf nu wordt verzocht de SAE/SUSAR en pregnancy formulieren te sturen naar De Safety documenten zijn ge-update.




08-11-2017: Een nieuw protocol / ICF amendement AM4 is door de EC goedgekeurd voor NL & BE sites. De documenten zijn ge-update voor de NL & BE-sites.


24-08-2016: We hebben een e-CRF ontwikkeld voor de HOVON 127 BL studie. ALEA is onze web-based database waarin we de studie data verzamelen voor HOVON studies.ALEA zal gebruikt worden voor alle studiedata, en u zult alle relevante behandel- en responsegegevens in kunnen voeren met uitzondering van:

-        Registratie van patiënten (gaat via TOP) ( zie HO127 R&R v5 20 JUL 2016)

-        SAE’s and pregnancy forms (need to be reported directly by fax) (zie HO127 pregnancy form v5 20 JUL 2016)


Let op: er zijn enkele aanpassingen in de e-CRF’s aangebracht, deels gerelateerd aan de mogelijkheden in ALEA, en o.a. aanpassingen m.b.t  imaging results CT-PET scan. De papieren CRFs v3 17 MAR 2016 komen dus te vervallen.



23-08-2016: Een nieuw protocol / ICF amendement AM3 is door de EC goedgekeurd voor BE sites. De documenten zijn ge-update voor de BE-sites.


19-07-2016: Een nieuw protocol / ICF amendement AM3 is door de EC goedgekeurd voor NL sites. De documenten zijn ge-update voor de NL-sites.



1. Overview



Study details

Type of study

Prospective randomized Phase III study

Echelon level

Level C-HIC

Type of monitoring for this study

Site evaluation visits

Target number of patients


Current number of patients


Date of activation


Approved by

NL: CCMO 26MAR2014

BE: METC St. Luc 13OCT2014 (AM1)
BE: FAGG 31JUL2014 (AM1)

Change history / amendement

AM1 NL: CCMO 12SEP2014
AM3 NL: CCMO 11JUL2016
AM4 NL: CCMO 04AUG2017

BE: METC St. Luc 18JUL2016 (AM3)
BE: FAGG 20JUL2016 (AM3)
BE: METC St. Luc 13SEP2017 (AM4)
BE: FAGG 22SEP2017 (AM4)

Study objectives

Primary objective:
• 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 .

Secondary objectives:
• To evaluate Overall Response Rate (ORR) end-of- treatment, Event Free Survival (EFS) and Overall Survival (OS) at 2 years
• To evaluate both regimens with respect to CTCAE grade ≥ 3 toxicity
• To evaluate both regimens with respect to hospitalization days

2. Patient eligibility criteria

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 < 1x10^9/l and platelets < 75x10^9/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

3. Registration (& randomization) of patients


Eligible patients should be registered before start of treatment. Patients need to be registered at the HOVON Data Center by one of the following options:
• Trial Online Process (TOP, A logon to TOP can be requested at the HOVON Data Center for participants.
• By faxing the completed registration/randomization CRF +31.10.7041028 Monday through Friday, from 09:00 to 17:00 CET
• By phone +31.10.7041560 Monday through Friday, from 09:00 to 17:00 CET

Registration criteria

The following information will be requested:

The following information will be requested at registration:
• Protocol number
• Institution name
• Name of caller/responsible investigator
• Local patient code (optional)
• Sex
• Date of birth
• Date written informed consent
• Specific items patient gives consent for (see ICF)
• Eligibility criteria
• Stratification factors

4. Participating parties

Principal Investigator(s)

Mw. Dr. M. Chamuleau (VUMC)


Dhr. Dr. G.W. van Imhoff (UMCG)

Coordinating Investigator(s)

Prof. E. van den Neste (Cliniques Universitaires St. Luc)


Mw. D. Chitu (Erasmus MC - Daniel)

Trial Manager(s)

Dhr. N. Lamers (Erasmus MC - Daniel)
Mw. S.C. Ly (Erasmus MC - Daniel)

Other functions

Reviewer - Pathology - HOP pathologist (VUMC)
Reviewer - Pathology - Mw. Dr. D. de Jong (VUMC)

Principal investigator

Dr. M.E.D. Chamuleau

Coordinating investigator(s)

BE: Prof. dr. E. van den Neste

Trial manager

J. Refos (

Central data management

R. Sewsaran (

Other functions

Co-investigator: dr. G.W. van Imhoff

5. Participating sites

Included patients *
BE-Antwerpen-ZNA Stuivenberg
BE-Bruxelles-Cliniques Universitaires St. Luc
CH-Basel-University Hospital Basel
CH-Bellinzona-IOSI, Ospedale Regionale
CH-Luzern-Kantonsspital Luzern
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
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* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos

7. Download documentation / forms


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