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Clinical picture: CML (Chronical Myeloide Leukemia)

Trial: HOVON 20 CML


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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1. Overview



Summary

A Randomized Phase III Study comparing Low Dose versus High Dose Interferon Alfa-2B (INTRON A) both combined with adapted doses of Hydroxyurea in Chronic Myeloid Leukemia.


Status

closed



Study details



Type of study

Prospective randomized Phase III study


Target number of patients

220


Date of activation

15-Jun-1993


Approved by

CKVO 93-06


2. Patient eligibility criteria



Inclusion criteria

Previously untreated newly diagnosed chronic myeloid leukemia in chronic phase.
Diagnosis made within 6 months before entry.
Presence of the Philadelphia chromosome or variant translocation without other unfavourable cytogenetic abnormalities.
Patients who do not show the presence of the Philadelphia chromosome may be included if the rearrangement of bcr/abl can be demonstrated.
Age above 18 years.
WHO performance status 0, 1 or 2.
Adequate hepatic and renal function.
Informed consent.


Exclusion criteria

Previous treatment for CML.
WHO performance status 3 or 4.
Life expectancy of less than 3 months.
Pregnancy and/or lactation.
Impossibility or unwillingness to take contraceptive measures.
Any underlying medical condition which will be aggravated by treatment or which cannot be adequately controlled.
Previous treatment with interferon or other lymphokines.
CML in acceleration or in blastic phase.
Patients unable to comply with the study medication schedules and necessary diagnostic procedures during follow-up.
Chromosomal abnormalities present at initial screening in addition to the t(9;22) and considered to be indicative for disease progression.
History of other malignancy except for treated non-melanotic skin cancer or surgically cured carcinoma in situ of the uterine cervix.
Clinically significant cardiomyopathy.
Those patients eligible for allogeneic BMT within 24 months from diagnosis.


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:



Patient's initials or code
Date of birth
Name of responsible physician and hospital
Date of diagnosis CML
Cytogenetics
The following data will be requested at randomization:
Patient's registration number
Name responsible physician and hospital
Date start Hydroxyurea
WBC count


4. Participating parties



Principal investigator

JC Kluin-Nelemans (J.C.Kluin-Nelemans@lumc.nl)


Central data management

Data Managers(Integraal Kankercentrum West):
JF van den Burgh
E Metselaar
J de Roo


Other functions

Statisticians:
J Hermans
JF van den Burgh
Central Cytogenetic Analysis:
A Hagemeijer (Anne.Hagemeijer@med.Kuleuven.ac.be)

Please contact monitors at hdcmonitorteam@erasmusmc.nl


5. Participating sites



6. Instruction videos



7. Download documentation / forms




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