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Clinical picture: MDS (Myelo-dysplastic Syndrome)

Trial: HOVON 60 MDS / SAKK 33/99


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

Antithymocyte globulin (ATG) and cyclosporine (CSA) in high risk myelodysplastic syndrome (MDS): a randomized trial comparing ATG + CSA with best supportive care


Status

closed


Members

This is an intergroup study in collaboration with the SAKK and was initialized by the SAKK.



Type of study

Prospective randomized Phase III study


Target number of patients

84


Approved by

CKTO: CKTO 2003-15, 10-02-2004
cMETC: METC VUMC 2003/137, 18-09-2003


2. Patient eligibility criteria



Inclusion criteria

Documented MDS
Patients in any of the following groups:
a. Hypoplastic MDS
b. MDS subtype RA (refractory anemia)
c. MDS subtype RAS (refractory anemia with sideroblasts)
d. MDS subtype RAEB (refractory anemia with excess of blasts) with 10-20% blasts in bone marrow and patient unwilling or not eligible to participate in the HOVON 42 or 43 study
Transfusion dependence of less than 24 months duration, defined as any of the following conditions:
a. Packed red cells transfusion > 2 units per month for a period of >= 2 months
b. Untransfused hemoglobin level <= 8 g/dl
c. Platelet transfusion > 1 unit per 2 weeks for a period of > 1 month
d. Untransfused platelet count <= 20x10^9/l
e. Neutrophils < 0.5x109/l
Age > 18 years
ECOG/SAKK performance status <= 2
Written informed consent


Exclusion criteria

MDS types CMMoL (chronic myelo-monocytic leukemia), RAEBt (refractory anemia with excess blasts in transformation)
Patients scheduled for bone marrow transplant
History of other hemato-oncological disease except for non melanoma skin cancer and adequately treated in situ carcinoma of the cervix
Prior chemotherapy or radiotherapy
Serum creatinine or bilirubin > 2.5 x upper limit of normal
History of heart failure, or clinically relevant cardiac arrhythmia
History of allergy to horse proteins, anaphylactic reactions to animal proteins, or history of serum sickness
Female patients with stablished pregnancy, or of childbearing age not practicing adequate contraceptive
Positive HIV serology
Active chronic hepatitis B or C
Active uncontrolled infection


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
Patient's initials
Date of birth
Sex
Institution name
Name of caller/responsible investigator
Patient's hospital record number
Eligibility criteria


4. Participating parties



Principal investigator

G.J. Ossenkoppele (g.ossenkoppele@vumc.nl)


Statistician(s)

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


Central data management

Central Datamanagement HOVON:
M.C.J. Testroote(m.testroote@erasmusmc.nl)
Central Datamanagement SAKK:
SIAK Coordinating Center (siakcc@sakk.ch)


Other functions

SAKK Trial chairperson:
J.R. Passweg


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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