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Clinical picture: MDS (Myelo-dysplastic Syndrome)


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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1. Overview


Randomised Phase II Study on the Value of Fludarabine in addition to ARA-C and G-CSF in the Treatment of Patients with Myelodysplastic Syndromes and Elderly Acute Myeloid Leukemia.



Study details

Type of study

Prospective randomized Phase II study

Target number of patients


Date of activation


Approved by

CKVO 96-03

2. Patient eligibility criteria

Inclusion criteria

Patients with ages between 15 and 75 years with a primary or secondary hematological diagnosis of myelodysplasia.
Patients with ages between 61 and 75 years with a primary or secondary diagnosis of AML.
Performance status 0, 1 or 2 according to the WHO performance scale
Serum creatinin < 120 �mol/l
Serum bilirubin < 25 �mol/l. ALAT and ASAT and AP less than 2.5 times the upper limit of normal.
Informed consent.

Exclusion criteria

Severe cardiac, pulmonary, neurologic, metabolic or psychiatric disease.
Malignancy, except stage I cervix carcinoma and basal carcinoma of the skin.
Active uncontrolled infections.
Chemotherapy within 6 months before entry to the study.
Blastic crisis of CML, or leukemia developing from Mypro.

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�s name
Patients Hospital registration number
Name of the responsible physician
Patient initials
Date of Birth
WHO performance status
Type of MDS or AML
Date of diagnosis

4. Participating parties

Principal investigator

GJ Ossenkoppele (

Coordinating investigator(s)

GEG Verhoef (

Trial manager

PHM Westveer (

Central data management

PHM Westveer (

Other functions

WJ Graveland (E-mail

Please contact monitors at

5. Participating sites

6. Instruction videos

7. Download documentation / forms

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