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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 61 NHL

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


Supportive care in chemotherapy-related anemia in elderly non-Hodgkin's lymphoma: Darbepoetin alfa (Ara-nesp�) versus red blood cell transfusion.

Study details

Type of study

Prospective randomized Phase III study

Target number of patients


Date of activation


Approved by

EudraCTnr.: 2004-000810-38
CKTO: CKTO 2004-08, 02-09-2004
cMETC: METC Erasmus MC, MEC-2004-209, 03-11-2004

Change history / amendement

Amendment 1: version 17-11-2004, activated 01-01-2005

2. Patient eligibility criteria

Inclusion criteria

Registration in the HOVON 46 NHL trial;
Hb levels <= 6.2 mmol/l (<= 10 g/dl);
Completion of baseline quality of life questionnaire;
Written informed consent

Exclusion criteria

Hypersensitivity to components of darbepoetin;
Treatment with epoetin or epoetin-related drugs within 4 weeks before registration in the HOVON 46 NHL trial;
Red cell transfusion after registration in the HOVON 46 NHL trial and within 4 weeks before randomization;
Correctable anemia not related to chemotherapy or bone-marrow infiltration such as deficiencies (iron, vit. B12, folic acid, autoimmune hemolysis);
Anemia due to other hematological diseases such as myelodysplastic syndromes or myeloproliferative syndromes;
Uncontrolled hypertension.

3. Registration (& randomization) of patients


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...:

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
Date of birth
Patient study number in HOVON 46 NHL trial
Treatment arm in HOVON 46 NHL trial
Number of cycles of CHOP (� rituximab) given according to HOVON NHL 46 trial before randomization
Eligibility criteria

4. Participating parties

Principal investigator

P.A.W. te Boekhorst (

Coordinating investigator(s)

P. Sonneveld (
P.C. Huijgens (

Trial manager

M.M.C. Steijaert (

Central data management

M.M.C. Steijaert (

Other functions

W.N. van Wieringen (

Please contact monitors at

5. Participating sites

Included patients *
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
NL-Nieuwegein-Antonius Ziekenhuis
NL-Rotterdam-Erasmus MC
NL-Rotterdam-Erasmus MC - Daniel
NL-Utrecht-UMC Utrecht

* 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


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