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Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON 66 AML


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

Hoge dosis ARA-C in combinatie met gemtuzumab ozogamicine (ARGO) als tweedelijns behandeling voor volwassen patiŽnten tot en met 60 jaar met AML en MDS die onvoldoende gereageerd hebben op eerstelijns behandeling.


Status

closed



Type of study

Prospective Phase II study


Target number of patients

44


Approved by

EudraCTnr.: 2004-002230-19
CKTO: CKTO 2004-11 (30-05-2005)
MEC: CMO Region Arnhem-Nijmegen (nr. 2004/237, 15-05-2005)


2. Patient eligibility criteria



Inclusion criteria

Age 18-60 years inclusive;
Diagnosis (cytopathologically confirmed) of AML (M0-M2 and M4-M7) or RAEB or RAEB-t with an IPSS score of >= 1.5;
The blood and BM picture, assessed after the first or second remission induction course in the latest non-GO intensive treatment should indicate failure to achieve CR and should be assessed by the local cytologist;
WHO performance status <= 2;
Written informed consent;


Exclusion criteria

AML M3 or AML with cytogenetic abnormality t(15;17) or AML with a PML/RAR alpha or a variant RAR alpha fusion gene;
Prior stem cell transplant;
Previous polycythemia rubra vera;
Primary myelofibrosis;
Blast crisis of chronic myeloid leukemia;
Hepatic dysfunction (bilirubin >= 2 x ULN);
Renal dysfunction (creatinine >= 2 x ULN);
Concomitant severe lung disease;
Concomitant severe cardiac dysfunction;
Concomitant neurological or psychiatric disease;
Concomitant malignant disease;
Active uncontrolled infection;
History of alcohol abuse, i.e. an average of > 5 alcoholic consumptions daily in the preceding year;
Pregnant or nursing woman;
Not able or willing to use adequate contraception during therapy (pre-menopausal women);
Known to HIV positivity;
Pretreatment with GO;
Any psychological, familial sociological and geographical condition potentially hampering compliance with the study protocol;


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 AML, RAEB or RAEB-t
Eligibility criteria


4. Participating parties



Principal investigator

T. de Witte (t.dewitte@hemat.umcn.nl)


Coordinating investigator(s)

S.M.G.J. Daenen (s.m.g.daenen@int.azg.nl)


Statistician(s)

W.L.J. van Putten (w.vanputten@erasmusmc.nl)


Trial manager

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


Central data management

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


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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