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 80 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


HO 80 news

As of November 4, 2011 the Ho80 NHL study is closed for patient inclusion.

Reason: total number of patients has been reached.


1. Overview



Summary

Phase II study on the feasibility and efficacy of R-DHAP + HD-MTX, combined with autologous stem cell transplantation in patients with a recurrent aggressive B-cell lymphoma with CNS localisation


Status

closed



Type of study

Prospective Phase II study


Type of monitoring for this study

Site evaluation visits


Target number of patients

39


Current number of patients

36


Date of activation

03-Oct-2006


Date closed

04-Nov-2011


Approved by

EudraCTnr.: 2006-002141-37
CKTO: 2006-11, 12 July 2006
MEC: METC Erasmus MC, MEC 2006-210, 28 September 2006


Change history / amendement

02-06-2009: MEC approval for
protocol version 10-02-2009
ICF version 10-02-2009


Study objectives

Evaluation of intensive therapy for relapsed B-cell
lymphoma with CNS localisation. Treatment includes:
a. intrathecal administration of rituximab
b. combining R-DHAP with high dose methotrexate intravenously
The following endpoints will be evaluated:
progression free survival, response rate and overall survival.


2. Patient eligibility criteria



Inclusion criteria

Diagnosis of aggressive malignant B-cell lymphoma based upon a representative histology specimen according to the WHO classification (see appendix A):
1. Follicular lymphoma grade III
2. Diffuse large B-cell lymphoma
Prior "low-grade" lymphoma with histologically proven transformation to follicular lymphoma grade III or DLBCL is also permitted.
CD 20 positive
First progression or relapse with CNS localisation (see below) without or with systemic relapse (preferably histologically proven). "Progressive" includes patients who have progressive disease (PD), without prior response and patients who have progression after first PR.
Diagnosis of CNS localisation based on at least one of the following:
1. Unequivocal morphological and/or immunophenotypical evidence of CSF lymphoma
2. clinical AND MRI evidence of leptomeningeal localisation
3. brain parenchymal lesion showing homogeneous contrast enhancement suspect for lymphoma, concurrently with systemic progression or recurrence
4. biopsy-proven brain parenchymal NHL localisation of previously diagnosed systemic NHL
Age 18-65 years inclusive
WHO performance status 0 - 2 (see appendix F) with or without administration of steroids
Written informed consent according to the centre's requirements
Negative pregnancy test in women of reproductive potential


Exclusion criteria

History of intolerance of exogenous protein administration
Severe cardiac dysfunction (NYHA classification III-IV, appendix G, or LVEF < 45%)
Severe pulmonary dysfunction (vital capacity or diffusion capacity < 50% of predicted value) unless clearly related to NHL involvement
Hepatic dysfunction, bilirubin or transaminase ? 2.5 x upper normal limit, unless related to lymphoma.
Renal dysfunction (serum creatinine ?150 umol/l or clearance ? 60 ml/min)
Prior cranial radiotherapy
Active uncontrolled infection
Known HIV-positivity
(EBV) post-transplant lymphoproliferative disorder
Documented CNS involvement during 1st line therapy (MTX intrathecal profylaxis during 1st line therapy is no exclusion criterium)


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
WHO classification
PA number (original, relapse and CNS if available)
PA laboratory (original, relapse and CNS if available)
Eligibility criteria


4. Participating parties



Principal Investigator(s)

Mw. Dr. J.K. Doorduijn (Erasmus MC - Daniel)


Co-Investigator(s)

Mw. Dr. J.E.C. Bromberg (Erasmus MC - Daniel)


Statistician(s)

Prof.dr.ir C.A.G. van Montfort (Erasmus MC - Daniel)


Trial Manager(s)

Mw. M.C.J. Abrahamse - Testroote (Erasmus MC - Daniel)


Central Data Manager(s)

Mw. M.C.J. Abrahamse - Testroote (Erasmus MC - Daniel)
Mw. E. de Klerk (Erasmus MC - Daniel)


Other functions

Reviewer - Pathology - Dhr. Dr. K.H. Lam (Erasmus MC - Centrum)


Principal investigator

J.E.C. Bromberg (j.bromberg@erasmusmc.nl)


Coordinating investigator(s)

J.K. Doorduijn (j.doorduijn@erasmusmc.nl)


Statistician(s)

W.L.J. van Putten (w.vanputten@erasmusmc.nl)


Trial manager

M. Abrahamse-Testroote (m.testroote@erasmusmc.nl)


Central data management

M. Abrahamse-Testroote (m.testroote@erasmusmc.nl)


5. Participating sites



Site
Included patients *
NL-Amsterdam-AMC
1
NL-Amsterdam-Antoni van Leeuwenhoek ZH
1
NL-Amsterdam-VUMC
0
NL-Enschede-Medisch Spectrum Twente
2
NL-Groningen-UMCG
7
NL-Maastricht-AZ Maastricht
7
NL-Nieuwegein-Antonius Ziekenhuis
0
NL-Nijmegen-Radboudumc
1
NL-Rotterdam-Erasmus MC - Daniel
16
NL-Rotterdam-Erasmus MC - Centrum
1
Show 2 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