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 130 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


HOVON 130 status

Link to the eCRF: https://prod.tenalea.net/emc/DM/DELogin.aspx?refererPath=DEHome.aspx (log in required)

 

Updated documents:

   25-jul-2017 (For The Netherlands only)

HO130 NHL protocol v6 18-may-2017 final _signed.pdf replaces the previous version HO130 NHL protocol v5 19-06-2016 final_signed is available for the Dutch participating centers 

ho130 ICF v6 18may2017 final voor sites.doc replaces the previous version HO130 ICF v5 12jun2015 voor site, for the Dutch participating centers 

HO130 NHL Positive decision letter METC VUmc for amendment 06 18-jul-2017 is available for the Dutch participating centers (added to cumulative document)

HO130 CCMO no objection statement amendment 06 11-jul-2017 is available for the Dutch participating centers  (added to cumulative document)

HO130 NHL CRF v9 24-jul-2017 replaces the previous version for the Dutch participating centers

HO130 Instructions for e-CRF completion version 17-jul-2017 replaces the previous version for the Dutch participating centers.

 

    18-AUG-2016

HO130 NHL protocol v5 19-06-2016 final_signed replaces the previous version HO130 NHL protocol v4 21-05-2016 (for all participating countries)

HO130 NHL Positive decision letter METC VUmc for amendment 04 17-AUG-2016 is available for the Dutch participating centers. (attached to cumulative document)

HO130 NHL CCMO no objection statement amendment 04 12-AUG-2016 is available for the Dutch participating centers. (attached to cumulative document)

HO130 NHL ABR-formulier versie 07 30-JUN-2016 replaces the previous version ABR versie 06 dd 05-APR-2016.pdf 

 

    23-may-2016

HO130 METc positief oordeel site amendement 3 NL50964.029.14 17-MAY-2016.pdf is available (attached to cumulative document)

HO130 CA goedkeuring_site amendement 3 20-MAY-2016.pdf is available. (attached to cumulative document)

HO130 ABR versie 06 dd 05-APR-2016.pdf is available.

    13-may-2016

HO130 Instructions for e-CRF completion version 19-APR-2016.pdf replaces the previous version HO130 Instructions for e-CRF completion version 29-JAN-2016.pdf

HOVON 130 NHL-CRF final v7 11-may-2016.pdf replaces HOVON 130 NHL CRF final v6 16-FEB-2016.pdf

    18-feb-2016

HO130 Instructions for e-CRF completion version 29-JAN-2016.pdf made available

HO130 HOVON 130 NHL CRF final v6 16-FEB-2016.pdf replaces previous version HOVON 130 NHL CRF final v5 11DEC2015.pdf

HO130 NHL-registration-form v6 16-FEB-2016.pdf replaces previous version HO130 NHL-registration-form v5 11DEC2015

    22-dec-2015

HOVON 130 NHL CRF final v5 11DEC2015.pdf replaces previous version HOVON 130 NHL CRF final v4 01APR2015.pdf

HO130 NHL-registration-form v5 11DEC2015 replaces previous version HOVON 130 NHL Registration form 01APR2015

    17-nov-2015

New IDOS manual HO130_IDOS_Training_Shipment to Participant Sites_V5_07-okt-2015 replaces previous version 3.1

 

News

   Update 25-JUL-2017

Amendment 06 containing an updated protocol, ICF, IB Lenalidomide v21 and approval for usage for rituximab IV biosimilars was approved and communicated to the participating centers in The Netherlands only. Amendment for Belgium is pending.

   Update 14-NOV-2016

Amendement 02 BE containing 'IB lenalidomide V19', 'IB lenalidomide V20' and 'study protocol v5 19-06-2016 final' been CA/EC approved for participating centers in Belgium

    Update 18-AUG-2016

Amendment 04 containing 'IB lenalidomide V19' and 'study protocol v5 19-06-2016 final' been CA/EC approved for  participating centers in The Netherlands.

     Update 23-MAY-2016

Site amendment 03 has been EC/CA approved. This amendment concerns only the participating centers in The Netherlands.

    Update 18-feb-2016

Activated centers have been informed about the availability of the ALEA eCRF database for the HOVON 130 NHL study

    Update 17-nov-2015

Various centers have opened for inclusion

     Update 14-jul-2015

De studie is geopend. Deelnemende sites zijn aan het opstarten.

    Update 14-apr-2015

De studie is op dit moment alleen open in VUMC.
Er wordt een amendment voorbereid en ingediend, alvorens de overige sites kunnen starten.


1. Overview



Summary

Patients with diffuse large B cell lymphoma (DLBCL) and with B-cell lymphomas, unclassifiable with features intermediate between diffuse large B cell lymphoma and Burkitt lymphoma (BCL-U) that harbor a MYC rearrangement (MYC+ DLBCL) have a dismal prognosis following treatment with standard therapy (R-CHOP). Lenalidomide is able to down-regulate MYC and its target genes and proteins in B cells that harbor a MYC rearrangement. The addition of lenalidomide to R-CHOP (R2CHOP) has been shown to be safe and might improve the prognosis of these patients.


Status

open


Members

HOVON



Type of study

Prospective Phase II study


Echelon level

Level D


Echelon level specification

Limited nr of sites


Type of monitoring for this study

Site evaluation visits


Target number of patients

85


Current number of patients

65


Approved by

NL METC: 25FEB2015
NL CA: 26JAN2015


Change history / amendement

AM01: Approved


Study objectives

Primary objective:

To evaluate the efficacy of the combination of lenalidomide and R-CHOP in MYC+ DLBCL patients in terms of CR rate by end-of-treatment 18F-FDG PET-CT scan and BM.

For DH -DLBCL patients the complete remission rate on R-CHOP was reported by Green at 64% in 2012. Later publications showed CR rates of 35%, 40% and 50%. For all DLBCL patients the CR/Cru rate after R-CHOP will be 58-63%. In this protocol we aim to improve the CR rate by end-of-treatment as assessed by 18F-FDG PET-CT from 45% to 60%.

Secondary objectives

To evaluate the efficacy of the addition of lenalidomide to R-CHOP for MYC+ DLBCL patients in terms of EFS, DFS and OS.

To evaluate the value of mid-treatment 18F-FDG PET-CT scanning in predicting end-of-treatment 18F-FDG PET-CT result.


2. Patient eligibility criteria



Inclusion criteria

DLBCL or BCL-U, histologically confirmed according to the WHO classification 2008 with a MYC rearrangement as determined by FISH comprising:
* single hit (SH MYC+ lymphoma, not fulfilling the criteria for Burkitt Lymphoma ) or
* double hit lymphoma (DH) MYC+/BCL2+ or MYC+/BCL6+ or
* triple hit lymphoma (TH) MYC+/BCL2+/BCL6+
Age ≥ 18 year
No prior treatment except
* local radiation or short course (max 7 days) steroids (max 100 mg/day)
* 1 course of R-CHOP in case MYC positivity became evident during first cycle of treatment
WHO performance status (PS) 0-3, status 4 only if disease related (see appendix C)
Ann Arbor stage II-IV
Measurable disease: on contrast-enhanced CT scan at least 1 lesions/node with a long axis of >1.5 cm and at least one positive lesion on 18F-FDG PET scan.
Negative pregnancy test at study entry
Patient is willing and able to adhere to the requirements of the lenalidomide
Pregnancy Prevention Risk Management Program
Written informed consent
Patient is capable of giving informed consent


Exclusion criteria

All histopathological diagnoses other than not otherwise specified DLBCL or BCL-U according to the WHO classification 2008 (like Burkitt lymphoma, DLBCL associated with chronic inflammation) irrespective of the presence of MYC rearrangement
Known history of indolent lymphoma, or presence of indolent lymphoma in the diagnostic lymph node. If during screening localization of an indolent lymphoma in the bone marrow biopsy is diagnosed, the patient is eligible.
absence of contrast-enhanced CT scan (neck, thorax, abdomen, pelvis) and 18F-FDG PET scan performed before first cycle of R-CHOP
Inadequate renal function or creatinine clearance < 30 mL/min (after rehydration). Creatinine clearance may be calculated by Cockcroft –Gault formula:
CrCl = (140 - age [in years]) x weight [kg] (x 0.85 for females) : (0.815 x serum creatinine [μmol/L])
Inadequate hepatic function: bilirubin > 3 times ULN (total) except patients with Gilbert's syndrome as defined by > 80% unconjugated bilirubin
Inadequate hematological function: ANC < 1.0x109/L or platelets < 75x109 /L unless lymphoma related
CNS localization of the lymphoma. Liquor analysis before start of treatment is only necessary in case of suspicion
Female subject pregnant or breast-feeding
History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
Active symptomatic ischemic heart disease, myocardial infarction, or congestive heart failure within the past year. If echo or MUGA is obtained the LVEF should exceed 40%
Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.) that would jeopardize the patient's ability to receive the regimen with reasonable safety
HIV positivity
Active Hepatitis B or C infection as defined by positive serology and transaminitis. Non-active Hepatitis B carriers may be included if protected with lamivudine (see 9.4)
Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D)
Severe neurological or psychiatric disease
Current participation in another clinical trial interfering with this trial
Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Claustrophobia to the extent that PET-CT is impossible


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
Age at registration
Date written informed consent
Specific items patient gives consent for (see ICF)
Eligibility criteria


4. Participating parties



Principal Investigator(s)

Mw. Dr. M. Chamuleau (VUMC)


Statistician(s)

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


Trial Manager(s)

Mw. J. Refos (Erasmus MC - Daniel)


Other functions

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


Principal investigator

Dr. M.E.D. Chamuleau


Coordinating investigator(s)

Dr. D. Dierickx


Trial manager

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


5. Participating sites



Site
Included patients *
BE-Leuven-UZ Gasthuisberg
2
NL-Amersfoort-Meander MC
0
NL-Amsterdam-AMC
8
NL-Amsterdam-VUMC
9
NL-Breda-Amphia ziekenhuis, locatie Langendijk
1
NL-Den Bosch-Jeroen Bosch ziekenhuis
0
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
2
NL-Dordrecht-A. Schweitzer ZH, Dordwijk
1
NL-Eindhoven-Maxima Medisch Centrum
1
NL-Enschede-Medisch Spectrum Twente
1
Show 13 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