HOVON HO105 NHL

Closed

Main info

Identifier:
HO105 NHL
Sponsor:
HOVON
Working group party:
Lymphoma
Age:
18-70
Stage:
1st Line
Echelon:
Level C-HIC
Included patients:
202
(of 202)
Active sites:
28
(of 29)
Title:

Rituximab in Primary Central Nervous system Lymphoma. A randomized HOVON / ALLG intergroup study

Timeline

Scheduled
Actual
2009
01 Jan
Opportunity
2009
27 May
Development
2009
08 Oct
Submission in Progress
2010
23 Jul
Activated
2010
23 Jul
EC Approval
2010
03 Aug
FPI
2010
03 Aug
First Site
2016
27 May
ClosedForInclusionActualStart
2017
30 Jun
Endpoint Analysis
2026
27 May
CloseoutInProgressLastPtOutScheduledStart

News

Amendment 5, concerning protocol (17DEC12), ICF template (17DEc12) and ICF template partner (17DEC12) has been approved by the cEC and CA of The Netherlands and must be implemented in Dutch sites from 22FEB2013 on.

Flow

Flow

Details

Phase:
Prospective randomized Phase III study
Monitoring Type:
Not any more
Objectives:

Primary objective:

  • To assess the effect of the addition of rituximab in a standard chemotherapy regime on EFS in newly diagnosed PCNSL

Secondary objective

  • To evaluate the effect of the addition of rituximab to a standard chemotherapy regimen with respect to toxicity

Eligibility

Inclusion Criteria:
  • Patients with a histologically confirmed diagnosis of CD20 positive DLBCL based upon a representative histology specimen of brain biopsy according to the WHO classification (see appendix A): OR
  • Patients with a diagnosis of PCNSL based on MRI evidence of brain parenchymal lesion showing homogeneous contrast enhancement suspect for lymphoma AND
    • Unequivocal morphological and/or immunophenotypical evidence of CSF CD20 + large cell lymphoma
    • AND/OR Unequivocal morphological and/or immunophenotypical evidence of CD20 + large cell lymphoma in vitreous fluid OR
  • Patients with unequivocal morphological and/or immunophenotypical evidence of CD20 + large cell lymphoma in vitreous fluid AND CSF but without a brain parenchymal lesion
  • Age 18-70 years inclusive
  • Performance status with or without administration of steroids WHO/ECOG 0 – 3 (see appendix D)
  • Written informed consent
Exclusion Criteria:
  • Evidence of systemic lymphoma
  • History of intolerance of exogenous protein administration
  • Severe cardiac dysfunction (NYHA classification III-IV, appendix G, or LVEF < 45%)
  • Congestive heart failure or symptomatic coronary artery disease or cardiac arythmias not well controlled with medication
  • Severe pulmonary dysfunction (vital capacity or diffusion capacity < 50% of predicted value)
  • Significant hepatic dysfunction (bilirubin or transaminase ≥ 2.5 x upper normal limit) at Screening.
  • Significant renal dysfunction (serum creatinine ≥150 μmol/l or clearance < 60 ml/min) at Screening
  • Presence of “third space fluid”, such as pleural effusion or ascites
  • Prior cranial radiotherapy
  • Active uncontrolled infection
  • HIV-positivity
  • (EBV positive) post-transplant lymphoproliferative disorder
  • Untreated hepatitis B infection (inclusion is possible if adequate antiviral medication e.g. lamivudine or alternative is started and continued for the duration of the trial)
  • Positive pregnancy test in women of reproductive potential
  • Lactating women
  • Unable or unwilling to use adequate contraceptive methods (all men, pre-menopausal women) until 12 months after last chemotherapy treatment
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • An active malignancy, that is expected to require treatment with chemotherapy within one year, or results in a life expectancy less than one year.

Registration Details

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:

  • By ALEA; Use goto eCRF button > select the [Patient tab] and click the [Add new patient] button. Complete all items and click the [Submit] button
  • By faxing the completed registration/randomization CRF +31 (0)10 704 1028 Monday through Friday, from 09:00 to 17:00 CET
  • By phone +31 (0)10 704 1560 Monday through Friday, from 09:00 to 17:00 CET

The following information will be requested at registration:

  • Protocol number
  • Institution name
  • Name of caller/responsible investigator
  • Patient’s name code
  • Gender
  • Date of birth
  • Date written informed consent
  • Specific items patient gives consent for (see ICF)
  • Eligibility criteria
  • Stratification factors

All eligibility criteria will be checked with a checklist. Patients will be randomized, stratified by center, age (≤ 60 vs ≥ 61 years) and WHO/ECOG performance status (0-1 vs 2-3) with a minimization procedure, ensuring balance within each stratum and overall balance. Each patient will be given a unique patient study number. Patient study number and result of randomization will be given immediately by TOP or phone and confirmed by fax or email.

Participating Sites

Ziekenhuizen die deelnemen aan het onderzoek staan benoemd op de HOVON website bij het onderzoek. Het kan zijn dat uw ziekenhuis niet genoemd wordt, maar wel aan het onderzoek deelneemt. Informeer hiernaar bij uw arts.

Site
28 results
Order by
Accrual rate
Activation date
NL-Rotterdam-EMCDANIEL
51
23 Jul 2010
NL-Utrecht-UMCUTRECHT
23
21 Oct 2010
NL-Tilburg-ETZ
17
31 May 2011
NZ-Auckland-MIDDLEMORE
15
23 Nov 2010
AU-Perth-SCGH
12
09 Dec 2010
NL-Maastricht-MUMC
9
26 Jul 2011
NL-Nijmegen-RADBOUDUMC
9
04 Jun 2013
NL-Amsterdam-VUMC
8
16 Dec 2010
NL-Hoofddorp-SPAARNEGASTHUIS
7
27 Apr 2012
NL-Groningen-UMCG
7
07 Apr 2011
AU-Melbourne-RMELBOURNE
7
09 Jan 2012
NL-Amsterdam-AVL
7
30 Nov 2010
NL-Den Haag-HAGA
6
29 Mar 2013
AU-Adelaide-RAH
5
16 Apr 2012
NL-Nieuwegein-ANTONIUS
5
08 Apr 2011
NL-Groningen-MARTINI
3
28 Nov 2013
AU-Brisbane-PAH
3
05 May 2011
NL-Zwolle-ISALA
3
13 Jun 2013
AU-Camperdown-RPA
1
31 May 2011
AU-Hobart TAS-RHOBART
1
27 Feb 2014
AU-Sydney-CONCORD
1
05 May 2011
NL-Den Bosch-JBZ
1
10 Jan 2012
NL-Enschede-MST
1
12 May 2011
AU-Melbourne-AUSTIN
16 Jun 2011
AU-Sydney-WSAH
23 Jun 2011
NL-Amsterdam-OLVG
23 Mar 2012
NZ-Christchurch-RBCHCHRISTCHURCH
19 Jul 2012
NZ-Wellington-CCDHB
29 May 2012
= Active hospitals
= Inactive hospitals

Participating Parties

Downloads

Up