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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


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News


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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. Löwenberg


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)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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