sluit venster

Log in

Gebruikersnaam Wachtwoord Gebruikersnaam en/of wachtwoord vergeten? Gebruikersnaam en wachtwoord aanvragen

Zoek in de HOVON website

Let op!
Mogelijk ziet u niet alle beschikbare info op deze pagina, omdat u niet bent ingelogd, of omdat u niet de juiste privileges heeft.

Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 84 NHL


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


return to top

News


HO84 news

 
Updated documents:
5 mar 2013: Nieuwe versie WMO-verklaring; Einddatum verzekering gewijzigd van dec2012 naar dec2014.
14 jan 2013: Nieuwe versie Rituximab Bestelfax.
 
April 10, 2012: The study is closed for inclusion of new patients, because the target (600 patients) has been reached. The randomization for maintenance treatment will not be closed before the last patient has reached this timepoint.
 
Updated documents: 
12oct2011: a new version of the FAQ sheet is added.
6sep2011: Nieuwe versie CRFs (versie 5, 1SEP2011). In deze versie zijn 3 vragen uit het Informed Consent  en 1 vraag over het nieuwe PK Informed Consent toegevoegd. Vanaf heden graag alleen deze versie gebruiken voor ALLE patienten. (Het SAE form is niet gewijzigd.)
 
6 sep 2011: Addendum Pharmacokinetic Evaluation Rituximab geaktiveerd (Amendement 5, alleen NL)
Deze Rituximab PK Side Study in 40 HOVON84 patienten, zal slechts in 9 NL centra gaan lopen (Erasmus MC, VUMC, Amphia, Jeroen Bosch, Haga, Alb. Schweizer, UMCG, MCL Antonius). De overige NL/B/DK centra hoeven dus geen aktie te ondernemen. Alle PK specifieke documenten (PK Addendum, PK ICF template, METC goedkeuring amendement, Site Documents Checklist AM5:PK addendum) zijn vanaf vandaag te downloaden vanaf de website.
 
Updated documents:
7jul2011: FAQ voor datamanagers is toegevoegd.
22 jun 2010: Nieuwe versie SAE form (versie 03, 22JUN2010) en nieuwe versie SAE report instructions (versie 04, 27APR2010)
25 mar 2010: Nieuwe versie Flowchart Clinical Evaluations (versie AM1)
21 jan 2010: Nieuwe versie Rituximab Bestelfax.
13 okt 09: nieuwe versie CRFs (versie 4, 12okt2009). In deze versie zijn enkele fouten in het 'Registratie&Randomization Form (1)' gecorrigeerd. 
 
Amendement 1:
Amendement 1 is op 16 september 2009 goedgekeurd door de nederlandse centrale METC (Erasmus MC). 
De belangrijkste wijzigingen in dit amendement zijn:
-         Het terugbrengen van het aantal twee-wekelijkse rituximab-CHOP kuren van 8 naar 6 voor oudere patienten (66-80 jaar) (Opm.: al aktief sinds juli 2009)
-         Het includeren van jongere patienten (18-65 jaar) met een aa-IPI van 1-3
-         Kleine wijziging in de centrale PET review procedure
-         De evaluatie van de respons blijft op dezelfde momenten plaatsvinden, dus na 4 kuren en na de laatste kuur.
 
Dit amendement is in Nederland vanaf donderdag 1 oktober 2009 aktief. Momenteel is het amendment ook in Belgie en Denemarken aktief. Dat betekent dat alle centra óók jongere patienten(18-65 jaar) mogen includeren. Het terugbrengen van het aantal R-CHOP kuren was al eerder geadviseerd  (mailing juli 2009)

1. Overview



Summary

Randomized phase III study on the effect of early intensification of rituximab in combination with 2-weekly CHOP chemotherapy followed by rituximab maintenance in patients with diffuse large B-cell lymphoma


Status

closed



Type of study

Prospective randomized Phase III study


Type of monitoring for this study

Site evaluation visits


Target number of patients

600


Current number of patients

585


Date of activation

25-Oct-2007


Approved by

EudraCTnr.: 2006-005174-42
CKTO: 2006-14, 08 February 2007
MEC: METC Erasmus MC 2007-055, 25 May 2007


Change history / amendement

Amendment 1 approved by METC Erasmus MC, 16 September 2009
Amendment 5 (Addendum Pharmacokinetic Evaluation Rituximab) approved by METC Erasmus MC, 30 August 2011


Study objectives

To evaluate the efficacy of:
a. early intensification of rituximab combined with 2- weekly CHOP+G-CSF (R-CHOP14) in remission induction treatment in comparison to standard RCHOP14
b. maintenance treatment with rituximab in patients in remission after R-CHOP14 in comparison to no further treatment


2. Patient eligibility criteria



Inclusion criteria

Patients with a confirmed histologic diagnosis of diffuse large B-cell lymphoma (DLBCL) based upon a representative histology specimen according to the WHO classification (see appendix A)
DLBCL must be CD20 positive
Ann Arbor stages II-IV (see appendix C)
Age 18-65 (inclusive) years and aa-IPI 1-3 (see appedix G)
OR Age 66-80 (inclusive) years and aa-IPI 0-3 (see appendix G)
WHO performance status 0 - 2 (see appendix E)
Written informed consent


Eligibility criteria for second randomization: Patients achieving a CR (or FDG-PET negative PR/CRu) after 6 cycles (elderly patients) or 8 cycles (young patients) of R-CHOP14 will be randomized to maintenance treatment with rituximab or no further treatment.
Patients in complete remission or FDG-PET negative partial remission/unconfirmed complete remission at least 4 weeks after the last cycle of R-CHOP14 (including last rituximab administration)
Time interval since last cycle of R-CHOP14 (including last rituximab administration) between 4 and 8 weeks
No rituximab-related adverse event necessitating stopping of rituximab administration
No active infection
Written informed consent


Exclusion criteria

Age 18-65 (inclusive) years and aa-IPI 0 (no risk factors, see appendix G)
Intolerance of exogenous protein administration
Severe cardiac dysfunction (NYHA classification III-IV, see appendix F) or LVEF < 45% Congestive heart failure or symptomatic coronary artery disease or cardiac arrhythmias not well controlled with medication. Myocardial infarction during the last 6 months
Severe pulmonary dysfunction (vital capacity or diffusion capacity < 50% of predicted value) unless clearly related to NHL involvement
Patients with uncontrolled asthma or allergy, requiring systemic steroid treatment
Significant hepatic dysfunction (total bilirubin ≥ 30µmol/l or transaminases ≥ 2.5 x upper normal limit), unless related to NHL
Significant renal dysfunction (serum creatinine ≥ 150 umol/l or clearance ≤ 60 ml/min), unless related to NHL
Clinical signs of severe cerebral dysfunction
Suspected or documented Central Nervous System involvement by NHL
Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
Testicular DLBCL
Primary mediastinal B cell lymphoma
Transformed indolent lymphoma
(EBV) post-transplant lymphoproliferative disorder
Secondary lymphoma after previous chemotherapy or radiotherapy
Major surgery, other than diagnostic surgery, within the last 4 weeks
Patients with active uncontrolled infections
Patients known to be HIV-positive
Active chronic hepatitis B or C infection
Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease)
Life expectancy < 6 months
Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except a short course of prednisone (< 1 week) and/or cyclophosphamide (< 1 week and not in excess of 900 mg/m2 cumulative) or local radiotherapy in order to control life threatening tumor related symptoms
History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...: http://www.hdc.hovon.nl/top


Registration criteria

The following information will be requested:



Protocol number
Institution name
Name of caller/responsible investigator
Patient's initials or code
Patient's hospital record number (optional)
Sex
Date of birth
Age-adjusted IPI risk score
PA number
Original PA laboratory (pathologist and institution)
Eligibility criteria


4. Participating parties



Principal Investigator(s)

Mw.Dr. P.J. Lugtenburg (Erasmus MC - Centrum)


Co-Investigator(s)

Mw. J.M. Zijlstra-Baalbergen (VUMC)


Statistician(s)

Dr. W. Ghidey Alemayehu (Erasmus MC - Daniel)
Dhr. Dr. B. van der Holt (Erasmus MC - Daniel)


Other functions

Central Coordinator - Special Investigations - Dhr. dr. E.F.I. Comans (VUMC)
Central Coordinator - Special Investigations - Prof. Dr. W.J.G. Oyen (Radboudumc)
Central Coordinator - Special Investigations - Dr. J. Pruim (UMCG)
Reviewer - Imaging - Mw. C. Karga (VUMC)
Reviewer - Pathology - Prof. Dr. Ph.M. Kluin (UMCG)
Reviewer - Pathology - Dhr. Dr. K.H. Lam (Erasmus MC - Centrum)
Reviewer - Pathology - Dhr. Dr. J.J. Oudejans (Diakonessenhuis)


Central data management

Nicole Thuss (n.thuss@erasmusmc.nl)
Henk Hofwegen (h.hofwegen@erasmus.mc.nl)
Tamara van Dijk (t.m.r.vandijk@erasmusmc.nl)
Christel van Hooije (c.vanhooije@erasmusmc.nl)


5. Participating sites



Site
Included patients *
BE-Antwerpen-ZNA Stuivenberg
9
BE-Leuven-UZ Gasthuisberg
15
DK-Aalborg-Aalborg Hospital
6
DK-Aarhus C-Aarhus University Hospital
28
DK-Copenhagen-Rigshospitalet Copenhagen
30
DK-Herlev-Herlev Hospital
4
DK-Holstebro-Regionshospital Holstebro
5
DK-Odense-Odense Universitetshospital
13
DK-Roskilde-Roskilde Sygehus
13
DK-Vejle-Vejle Hospital
6
Show 58 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



return to top