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Clinical picture: MDS (Myelo-dysplastic Syndrome)

Trial: HOVON 34 MDS / EORTC 06961


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

Autologous Peripheral Blood Stem Cell Transplantation (PSCT) versus a second Intensive Consolidation Course after a Common Induction and Consolidation Course in Patients with bad prognosis Myelodysplatic Syndromes (MDS) and Acute Myelogenous Leukemia secondary (SAML) to MDS of more than 6 months duration: A Phase III Study.


Status

closed


Members

Hovon 34 is an Intergroup Study, with the following centers participating:
EORTC LEUKEMIA COOPERATIVE GROUP; R Willemze (Chairman)
EBMT CHRONIC LEUKEMIA WORKING PARTY; J Apperly (Chairman)
GIMEMA; F Mandelli (Chairman)
SAKK; A Goldhirsch (Chairman)
HOVON; B L�wenberg (Chairman)



Study details



Type of study

Prospective randomized Phase III study


Target number of patients

240


Date of activation

15-Dec-1996


Approved by

The promotor of the study is the EORTC.
Pharmacia and Upjoin provides an educational grant to this study.
The translational part of the study (Project CRIANT) is supported by the European commission through BIOMED-2 program and by an educational grant of Amgen.


2. Patient eligibility criteria



Inclusion criteria

All patients with untreated RAEBt, RAEB with > 10% blast cells in the bone marrow, other forms of MDS with multiple chromosomal abnormalities, and/or profound cytopenias, and secondary AML supervening after overt MDS of more than 6 months duration are eligible for the study.
Patients between 10 and 60 years.
Informed consent and expected cooperation of the patient with regard to treatment and follow-up.
Performance status according to WHO: scale 0, 1 or 2.


Exclusion criteria

Blast crisis of chronic myeloid leukemia.
Leukemias supervening after other myeloproliferative diseases.
Leukemias supervening after overt MDS of less than 6 months duration.
Inadequate renal and liver function.
Patients with severe heart failure.
Patients with severe concomitant neurological disease.
Other progressive malignant diseases. However, secondary acute leukemias following cured Hodgkin�s disease or other malignancies will be included, as well as secondary leukemias following other exposure to alkylating agents or radiations for any other reason.
Patients already treated for their MDS or AML by intensive chemotherapy, and/or radiotherapy.
Patients treated with biological response modifiers and/or low dose Ara-C within 4 weeks prior to entry.


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:



Institution number
Protocol number
Patient code
Patient�s hospital record number
Patient�s date of birth
Previous treatment


4. Participating parties



Principal investigator

T de Witte (Nijmegen)


Coordinating investigator(s)

G Verhoef (Leuven) (gregor.verhoef@uz.kuleuven.ac.be)
F Mandelli (Roma)
U Hess (St. Gallen)


Central data management

M Dardenne (Brussels)
G Solbu (Brussels)


Other functions

Statistician:
S Suciu (Brussels)

Please contact monitors at hdcmonitorteam@erasmusmc.nl


5. Participating sites



6. Instruction videos



7. Download documentation / forms




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