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Clinical picture: CML (Chronical Myeloide Leukemia)

Trial: HOVON 78 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


HO78 news

On 31 December 2013 HOVON 78 CML was closed. No further data will be collected.

1. Overview



Summary

Imatinib in combination with Cytarabin as compared to Imatinib alone in patients with first chronic phase Chronic Myeloid Leukemia. A prospective randomized study.


Status

closed



Study details



Type of study

Prospective randomized Phase III study


Type of monitoring for this study

Site evaluation visits


Target number of patients

330


Date of activation

24-May-2006


Date closed

01-May-2010


Approved by

CKTO: 27 March 2006 (with respect to content)
MEC: 09 May 2006


Study objectives

To determine the efficacy of the combination of imatinib with cytarabine as compared to imatinib alone in terms of the rate of molecular response at 12 months from randomization.


2. Patient eligibility criteria



Inclusion criteria

Newly diagnosed patients with CML in first chronic phase ? 2 months;
Presence of Philadelphia chromosome or bcr-abl rearrangement;
Age 18-65 years inclusive;
WHO performance status ? 2 (see appendix E);
Written informed consent.


Exclusion criteria

CML in accelerated phase or blastic crisis as defined by the WHO criteria (see appendix A).
Hepatic dysfunction (serum bilirubin ? 2 x N, and/or ALAT ? 4 x N, and/or ASAT ? 4 x N);
Renal dysfunction (creatinine ? 200 ?mol/l or 2.3 mg/dl);
Severe cardiac dysfunction (NYHA classification II-IV, see appendix F);
Severe pulmonary or neurologic disease;
Pregnant or lactating females;
Patients with a history of active malignancy during the past 5 years with the exception of
basal carcinoma of the skin or stage 0 cervical carcinoma;
Patients known to be HIV-positive;
Patients with active, uncontrolled infections;
Previous treatment other than hydroxyurea ? 2 months or imatinib ? 1 month;
Male and female patients of reproductive potential who are not practicing effective means of
contraception.


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
Institution name
Name of caller/responsible investigator
Patient?s initials or code
Patient?s hospital record number (optional)
Sex
Date of birth
Date of diagnosis CML
Eligibility criteria


4. Participating parties



Principal investigator

J.J. Cornelissen (j.cornelissen@erasmusmc.nl)


Coordinating investigator(s)

G.J. Ossenkoppele (g.ossenkoppele@vumc.nl)
G.E.G. Verhoef (gregor.verhoef@uz.kuleuven.ac.be)


Statistician(s)

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


Trial manager

A.H.M. Ammerlaan (a.ammerlaan@erasmusmc.nl)


Central data management

A.H.M. Ammerlaan (a.ammerlaan@erasmusmc.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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