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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 63 NHL


News
1. Overview
Study details
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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1. Overview



Summary

Randomized phase III study of Rituximab with intensified CHOP chemotherapy (R-iCHOP-14) versus Rituximab with High-Dose Sequential Therapy and Autologous Stem Cell Transplantation (R-HDT+ASCT) in Adult Patients (18-65 yrs) with Stage II-IV High-intermediate or High Risk Diffuse Large B-Cell Lymphoma


Status

closed



Study details



Type of study

Prospective randomized Phase III study


Target number of patients

250


Date of activation

28-Oct-2005


Date closed

25-Mar-2008


Approved by

EudraCTnr.: 2005-001370-27
CKTO: CKTO (2005-13), 20-10-2005
MEC: METc UMCG (2005.127), 16-08-2005


2. Patient eligibility criteria



Inclusion criteria

Patients with a confirmed histologic diagnosis of DLBCL according to the WHO classification;
Ann Arbor stage II-IV;
High-intermediate or high risk NHL according to age-adjusted IPI score (aa IPI=2-3);
DLBCL must be CD20 positive;
Age 18-65 years inclusive;
WHO performance status <= 2;
Negative preganacy test (if applicable);
Written informed consent;


Exclusion criteria

Intolerance of exogenous protein administration;
Severe cardiac dysfunction (NYHA classification II-IV, Appendix F) or LVEF < 45 %;
Significant renal dysfunction (serum creatinine >= 150 mmol/l), unless related to NHL;
Significant hepatic dysfunction (total bilirubin >= 30 mmol/l or transaminases >= 2.5 times normal level), unless related to NHL;
Suspected or documented Central Nervous System involvement by NHL;
Testicular DLBCL;
Primary mediastinal B cell lymphoma;
Patients known to be HIV-positive;
Patients with active, uncontrolled infections;
Patients with uncontrolled asthma or allergy, requiring steroid treatment;
Patient is a lactating woman;
Unwillingness or not capable to use effective means of anticonception (all men and pre-menopausal women);
Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except a short course of prednisone (< 1 wk) and/or cyclophosphamide (< 1 wk and not in excess of 900 mg/m^2 cumulative) or local radiotherapy in order to control life threatening tumor related symptoms;
History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma;


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 initials or code
Patient hospital record number
Sex
Date of birth
Date of diagnosis DLBCL
Age adjusted IPI score
Ann Arbor stage
LDH
ULN for LDH
PA number
Location of PA tissue blocks (pathologist and institution)
Eligibility criteria


4. Participating parties



Principal investigator

G.W. van Imhoff (g.w.van.imhoff@int.umcg.nl)


Coordinating investigator(s)

L.F.Verdonck (l.f.verdonck@umcu.nl)


Statistician(s)

B. van der Holt (b.vanderholt@erasmusmc.nl)


Trial manager

F.M. Spoelstra (f.spoelstra@erasmusmc.nl)


Central data management

F.M. Spoelstra (f.spoelstra@erasmusmc.nl)


Other functions

Central Pathologists:
Ph.M. Kluin (p.m.kluin@path.umcg.nl)
K. Hebeda (k.hebeda@pathol.umcn.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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