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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 85 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


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News


HO85 news

End of inclusion

As of March 1, 2012, the HOVON 85 NHL study is closed for entry of new patients since the target number of patients has been reached. We thank you for your cooperation in this study and we hope for a succesfull continuation towards the end of the trial.

New WMO certificate online

The new WMO certificate (which expires APRIL 2013) can now be found on this website.

 

CRFs

A new version of the CRFs is available. Mainly the R-PECC treatment form has been modified.

Please use this new version from now on and discard any old versions.


1. Overview



Summary

Phase II study on the feasibility and efficacy of consolidation with 90Y-ibritumomab tiuxetan in patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma having achieved partial or complete remission after induction with R-PECC chemotherapy.


Status

closed



Type of study

Prospective Phase II study


Type of monitoring for this study

Site evaluation visits


Target number of patients

60


Current number of patients

61


Date of activation

15-Aug-2008


Date closed

01-Mar-2012


Approved by

EudraCTnr.: 2006-007083-28
CKTO: 2007-10, 12 July 2007
MEC: METC Erasmus MC, 18 June 2008


2. Patient eligibility criteria



Inclusion criteria

Inclusion criteria R-PECC induction:
Histologically confirmed aggressive B-cell NHL according to the World Health Organization (WHO) classification (see appendix A):
Follicular lymphoma grade 3b
Diffuse large B-cell lymphoma
Refractory disease or histologically confirmed first or second relapse
(Refractory is defined as no response or partial remission according to CT. Patients in partial response (PR) can only be included in case of positive PET scan or positive biopsy)
CD20 positive (assessed at 1st diagnosis or from fresh histology at confirmation of relapse or immunophenotyping of circulating CD20-positive NHL cells from peripheral blood)
Current measurable disease, i.e. measurable in two perpendicular dimensions on physical examination or computerized tomography (CT) scan using standardized response criteria for NHL (Cheson et al21, 1999) (see appendix B)
Age > 18 years
WHO performance status 0, 1 or 2 (see
appendix E)
Life expectancy of at least 3 months
Absolute neutrophil count > 1.5 x 109/l and platelet count > 100 x 109/l (unless caused by NHL infiltration in the bone marrow)
Written informed consent

Inclusion criteria 90Y-ibritumomab tiuxetan consolidation:
Patients with PR or CR after 4 cycles of R-PECC
Less than 25% bone marrow involvement (confirmed by bone marrow biopsy of at least 1.5 cm, if initially positive)
WHO performance status 0, 1, or 2
Time interval since the start of the 4th R-PECC between 6 and 12 weeks
No rituximab-related adverse event necessitating stopping of rituximab administration


Exclusion criteria

Exclusion criteria R-PECC induction:
Prior allogeneic stem cell transplantation
Prior radioimmunotherapy
Patients who have received chemotherapy or radiotherapy within 6 weeks prior to study entry or who have not recovered from toxicities related to prior therapies
Eligibility for ASCT
ASCT within 12 months of study entry
Investigational drugs within 4 weeks prior to entry on this study or persistent toxic side effects of such therapy
Treatment with external-beam radiation therapy to more than 25% of active bone marrow (see appendix F)
A history of intolerance to rituximab
Severe cardiac, pulmonary, neurological, psychiatric or metabolic disease which could compromise participation in the study, or serious underlying medical conditions which could impair the ability of the patient to participate in the trial
Hepatic dysfunction, bilirubin or transaminases >= 2.5 x upper normal limit (unless caused by the NHL)
Renal dysfunction, serum creatinine >= 180 mmol/l or clearance <= 40 ml/min (unless caused by the NHL)
Active uncontrolled infections
Patients known to be HIV-positive
Current or chronic hepatitis B or hepatitis C infection
Symptomatic NHL localization in the central nervous system (CNS). Lumbal puncture is not required unless CNS involvement with NHL is clinically suspected
Transformed indolent lymphoma
Post-transplant lymphoproliferative disorder
Pregnant or breast-feeding female patients. Negative serum pregnancy test at study is mandatory for female patients of childbearing potential

Exclusion criteria 90Y-ibritumomab tiuxetan consolidation:
All exclusion criteria mentioned for R-PECC induction, plus the following:
Extensive pleural effusion or ascites
Impaired bone marrow reserve, as indicated by one or more of the following:
Absolute neutrophil count < 1.5 x 109/l, platelet count < 100 x 109/l, Hemoglobin < 5.0 mmol/l
Hypoplastic bone marrow at biopsy
Administration of systemic corticosteroids at doses higher than 20 mg/day prednisolone or equivalent 2 weeks prior to 90Y-ibritumomab tiuxetan administration.


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:



PA number
Original PA laboratory
Did patient give consent for PA review? (yes/no, see ICF)
Did patient give consent for participation in 'side studies'? (yes/no, see ICF)


4. Participating parties



Principal Investigator(s)

Dhr. Dr. R.E. Brouwer (Reinier de Graaf Gasthuis)
Dhr.Dr. G.W. van Imhoff (UMCG)
Mw.Dr. P.J. Lugtenburg (Erasmus MC - Centrum)
Mw. J.M. Zijlstra-Baalbergen (VUMC)


Statistician(s)

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


Trial Manager(s)

Mw M. Luten (Erasmus MC - Daniel)


Central Data Manager(s)

Dhr. H. Hofwegen (Erasmus MC - Daniel)


Other functions

Reviewer - Imaging - Mw. C. Karga (VUMC)
Reviewer - Pathology - Dhr. Dr. K.H. Lam (Erasmus MC - Centrum)


Principal investigator

Dr. P.J. Lugtenburg (Erasmus MC)


5. Participating sites



Site
Included patients *
NL-Amstelveen-Ziekenhuis Amstelland
0
NL-Amsterdam-AMC
2
NL-Amsterdam-Slotervaart Ziekenhuis
0
NL-Amsterdam-VUMC
7
NL-Capelle a/d IJssel-IJsselland Ziekenhuis
0
NL-Delft-Reinier de Graaf Gasthuis
2
NL-Delfzijl-Delfzicht ziekenhuis
0
NL-Den Bosch-Jeroen Bosch ziekenhuis
1
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
7
NL-Dordrecht-A. Schweitzer ZH, Dordwijk
3
Show 17 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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