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Clinical picture: AML (Acute Myeloide Leukemia)
Trial: HOVON 59 AML / SAKK / OSHO
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
News
No news
1. Overview
Summary
Anti-CD33 antibody (Gemtuzumab Ozogamicin) prior to allografting with reduced intensity conditioning in patients with acute myelocytic leukemia (AML) or myelodysplasia: a phase II feasibility study
Status
closed
Members
HOVON, SAKK, OSHO
Study details
Type of study
Prospective Phase II study
Target number of patients
20
Date of activation
16-Apr-2004
Date closed
27-May-2005
Approved by
METC: Erasmus MC March 23, 2004
2. Patient eligibility criteria
Inclusion criteria
HLA identical sibling donor, or molecularly matched (9/10 or 10/10) unrelated donor
Donor must consent to hematopoietic stem cell harvest from peripheral blood (preferably) or from bone marrow
Donor meets the institutional guidelines for stem cell harvest
Age = 16 years or = 75 years
Exclusion criteria
Pregnancy
HIV positivity
Current serious systemic illness
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's initials or code
Patient's hospital record number
Sex
Date of birth
Date of diagnosis of AML, RAEB or RAEB-t
Inclusion in other study?
Eligibility criteria.
4. Participating parties
Principal investigator
J.J. Cornelissen
Coordinating investigator(s)
A. Gratwohl
L.F. Verdonck
D. Niederwieser
B. L�wenberg
Statistician(s)
W.L.J. van Putten (w.vanputten@erasmusmc.nl)
Trial manager
C.M.C. van Hooije (c.vanhooije@erasmusmc.nl)
Central data management
C.M.C. van Hooije (c.vanhooije@erasmusmc.nl)
Other functions
Please contact monitors at hdcmonitorteam@erasmusmc.nl
5. Participating sites
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.
