sluit venster

Log in

Gebruikersnaam Wachtwoord Gebruikersnaam en/of wachtwoord vergeten? Gebruikersnaam en wachtwoord aanvragen

Zoek in de HOVON website

Let op!
Mogelijk ziet u niet alle beschikbare info op deze pagina, omdat u niet bent ingelogd, of omdat u niet de juiste privileges heeft.

Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON 52 AML

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

return to top


No news

1. Overview


Treatment of Acute Promyelocytic Leukemia: Remission Induction with ATRA+Idarubicin (AIDA). Risk Adapted Intensity of Consolidation and Addition of ATRA Maintenance with ATRA + Methotrexate + Mercaptopurine Rescue Therapy for Molecular and Haematological Relapses



Study details

Type of study

Prospective Phase II study

Target number of patients


Date of activation


Approved by

MEC: METC AZG 2001/140c, 24 August 2001

2. Patient eligibility criteria

Inclusion criteria

Age 18-75 years, inclusive;
ECOG Performance status <= 3;
Morphological diagnosis of M3 or M3v. Those cases without typical morphology but with PML-RARa rearrangement may also be included;
Genetic diagnosis: t(15;17), PML-RARa rearrangement, monoclonal anti-PML positive. Obviously, the result of these tests may become available after having initiated the treatment based on a tentative morphological diagnosis. The presence of secondary cytogenetic changes associated with t(15;17) is not a reason for exclusion nor do they require a different therapeutic approach;
Written informed consent.

Exclusion criteria

Age >75 years (the treatment with this protocol can be considered on an individual basis but these patients will be analysed separately);
Absence of PML-RARa rearrangement;
Prior antileukemic chemotherapy;
Presence of an associated neoplasm;
Presence of a severe psychiatric disease;
HIV seropositivity;
Contraindication for intensive chemotherapy, especially to anthracyclines;
Serum creatinine >= 2.5 mg/dL;
Bilirubin, alkaline phosphatase, or SGOT > 3 times the upper normal limit;
Positive pregnancy test;

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�s initials or code
Patient�s hospital record number
Date of birth
Date of diagnosis of AML
Eligibility criteria

4. Participating parties

Principal investigator

E. Vellenga (

Coordinating investigator(s)

B. L�wenberg (


W.L.J. van Putten (

Trial manager

F. Spoelstra (

Central data management

F. Spoelstra (

Other functions

Please contact monitors at

5. Participating sites

6. Instruction videos

7. Download documentation / forms


return to top