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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 127 BL


News
1. Overview
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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News


HO127 news

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



Status

open



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

260


Current number of patients

16


Date of activation

19-Jun-2014


Approved by

NL: METC VUMC 13MAY2014
NL: CCMO 26MAR2014

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


Change history / amendement

AM1 NL: METC VUMC 02SEP2014
AM1 NL: CCMO 12SEP2014
AM2 NL: METC VUMC 21OKT2015
AM2 NL:CCMO 2NOV2015
AM3 NL: METC VUMC 11JUL2016
AM3 NL: CCMO 11JUL2016

BE: METC St. Luc 18 JUL 2016 (AM3)
BE: FAGG St. Luc 20 JUL 2016 (AM3)


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;
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;
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 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 hematological 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 jeopardize the patient's ability to receive the regimen with reasonable safety, includig active hepatitis B (HBV) 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



Registration

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, https://www.hdc.hovon.nl/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)


Co-Investigator(s)

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


Coordinating Investigator(s)

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


Statistician(s)

Mw. Dr.ir D. Chitu (Erasmus MC - Daniel)


Trial Manager(s)

Dhr. N. Lamers (Erasmus MC - Daniel)
Mw. J. Refos (Erasmus MC - Daniel)


Central Data Manager(s)

Dhr.drs. R. Sewsaran (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

N.G.J.H. Lamers (n.lamers@erasmusmc.nl)


Central data management

R. Sewsaran (r.sewsaran@erasmusmc.nl)


Other functions

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


5. Participating sites



Site
Included patients *
BE-Antwerpen-ZNA Stuivenberg
2
BE-Bruxelles-Cliniques Universitaires St. Luc
1
BE-Roeselare-AZDelta
0
NL-Amsterdam-AMC
1
NL-Amsterdam-OLVG
1
NL-Amsterdam-VUMC
1
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
0
NL-Eindhoven-Maxima Medisch Centrum
1
NL-Enschede-Medisch Spectrum Twente
0
NL-Groningen-UMCG
1
Show 7 more...
* 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


 Protocol



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