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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 105 PCNSL / ALLG NHL24


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


Ho105 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.

1. Overview



Summary

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


Status

closed


Members

Participating groups: HOVON, ALLG


Validity

Protocol version 17DEC12 valid in The Netherlands



Type of study

Prospective randomized Phase III study


Echelon level

Level C-HIC


Echelon level specification

A limited nr. of hospitals can participate.


Type of monitoring for this study

Site evaluation visits


Target number of patients

202


Current number of patients

200


Date of activation

23-Jul-2010


Date closed

27-May-2016


Approved by

Eudra CT nr.: 2009-014722-42
CKS: 2009-4589
MEC: METC Erasmus MC 2009-399


Study objectives

To assess the effect of the addition of rituximab in a standard chemotherapy regime on EFS in newly diagnosed PCNSL
To evaluate the effect of the addition of rituximab to a standard chemotherapy regimen with respect to toxicity


2. Patient eligibility criteria



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 micro?mol/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


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) Monday through Sunday, 24 hours/day. 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:



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


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)


Coordinating Investigator(s)

Ms. Dr. I. Issa (Middlemore Hospital)


Statistician(s)

Ms. K. Bakunina (Erasmus MC - Daniel)


Monitor - Site Evaluation Visits

M. Spaans (Erasmus MC - Daniel)


Other functions

Central Coordinator - Special Investigations - Ms. J. Dracopoulos (Princess Alexandra)
Reviewer - Imaging - Mw. Dr. J.E.C. Bromberg (Erasmus MC - Daniel)
Reviewer - Pathology - Prof. M. Gonzales (Royal Melbourne Hospital)
Reviewer - Pathology - Prof. Dr. Ph.M. Kluin (UMCG)
Reviewer - Pathology - Dhr. Dr. K.H. Lam (Erasmus MC - Centrum)


Trial manager

Martine Abrahamse-Testroote


Central data management

Martine Abrahamse-Testroote


5. Participating sites



Site
Included patients *
AU-Adelaide-Royal Adelaide Hospital
5
AU-Brisbane-Princess Alexandra
3
AU-Camperdown-Royal Prince Alfred Hospital
1
AU-Hobart TAS-Royal Hobart Hospital
1
AU-Melbourne-Austin Health
0
AU-Melbourne, Parkville Vic-Royal Melbourne Hospital
7
AU-Perth-Sir Charles Gairdner Hospital
10
AU-Sydney-Concord Repatriation General Hospital
1
AU-Westmead, Sydney-Westmead Hospital
0
NL-Amsterdam-Antoni van Leeuwenhoek ZH
7
Show 18 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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