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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 61 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


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1. Overview



Summary

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



Type of study

Prospective randomized Phase III study


Target number of patients

150


Date of activation

17-Nov-2004


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



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
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 (p.teboekhorst@erasmusmc.nl)


Coordinating investigator(s)

P. Sonneveld (p.sonneveld@erasmusmc.nl)
P.C. Huijgens (pc.huijgens@vumc.nl)


Trial manager

M.M.C. Steijaert (m.steijaert@erasmusmc.nl)


Central data management

M.M.C. Steijaert (m.steijaert@erasmusmc.nl)


Other functions

Statistician:
W.N. van Wieringen (w.vanwieringen@erasmusmc.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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