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Clinical picture: CML (Chronical Myeloide Leukemia)

Trial: HOVON 38 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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News


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1. Overview



Summary

High-dose Cytarabin versus low-dose Cytarabin plus Interferon-Alpha-2a both followed by maintenance with Interferon-Alpha-2a in Chronic Myeloid Leukemia: A Phase III study by HOVON and the Belgian CMC Study Group.


Status

closed


Members

HOVON 38 is a study by HOVON and the Belgian CML Study Group.



Study details



Type of study

Prospective randomized Phase III study


Target number of patients

280


Date of activation

15-Jan-1998


Date closed

15-Jun-2001


Approved by

CKVO 97-05


2. Patient eligibility criteria



Inclusion criteria

Newly diagnosed patients with CML in first phase < 6 months.
Presence of Philadelphia chromosome or BCL/ABL rearrangement.
Age: 16-65 years inclusive.
WHO performance scale 0, 1, 2.
Informed consent.


Exclusion criteria

CML in blastic phase.
CML in accelerated phase.
CML without Ph chromosome or BCL/ABL rearrangement.
Hepatic dysfunction.
Renal dysfunction.
Patients with severe cardiac, pulmonary or neurologic disease.
Pregnant or lactating females.
Human Immunodeficiency Virus (HIV) infection.
Other malignancies, except stage I cervix carcinoma and basocellular carcinoma.


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
Name of caller and physicisn in charge
Institution�s name
Patient�s name code, date of birth and sex
Hospital record number


4. Participating parties



Principal investigator

JJ Cornelissen (cornelissen@hemh.azr.nl)


Coordinating investigator(s)

(HOVON) GJ Ossenkoppele (ossenkoppele@azvu.nl)
(Belgian CML Study Group) GEG Verhoef
(gregor.verhoef@uz.kuleuven.ac.be)


Statistician(s)

B. van der Holt (b.vanderholt@erasmusmc.nl)


Central data management

A Meurisse (E-mail Address: meurisse@stah.azr.nl)


Other functions

Please contact monitors at hdcmonitorteam@erasmusmc.nl


5. Participating sites



Site
Included patients *
BE-Antwerpen-ZNA Middelheim
0
BE-Antwerpen-ZNA Stuivenberg
0
BE-Bruxelles-Cliniques Universitaires St. Luc
1
BE-Leuven-UZ Gasthuisberg
15
NL-Alkmaar-MC Alkmaar
0
NL-Amersfoort-Meander MC
4
NL-Amsterdam-AMC
0
NL-Amsterdam-VUMC
16
NL-Apeldoorn-Gelre ziekenhuizen, Apeldoorn
1
NL-Den Bosch-Jeroen Bosch ziekenhuis
1
Show 12 more...
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos



7. Download documentation / forms




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