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Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON 43 AML


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


HO43 news

Thanks to the efforts of many people, the HOVON 43 AML study is successfully completed and an article has been published in the New England Journal of Medicine.

This article can be found using the following Reference:
Löwenberg B, Ossenkoppele GJ, Van Putten WI, et al. High-dose daunorubicin in older patients with acute myeloid leukemia. N Engl J Med 2009;361:1235-48.

Or go to the following link:
http://nejm.highwire.org/cgi/content/short/361/13/1235

On behalf of the study team, we thank all that have contributed to this study profoundly.

1. Overview



Summary

Randomized induction and post induction therapy in older patients (>= 61 yrs of age) with acute myelocytic leukemia (AML) and refractory anemia with excess of blasts (RAEB, RAEB-t)


Status

closed



Type of study

Prospective randomized Phase III study


Target number of patients

600


Date of activation

09-Oct-2000


Date closed

15-Jun-2006


Approved by

CKVO: CKVO 2000-05, 19 September 2000
MEC: METC EUR/AZR, 30 August 2000


Study objectives

Evaluation of the effect of an escalated dose of Daunomycin in induction treatment
Evaluation of the effect of maintenance treatment with GO (gemtuzumab ozogamicin, anti-CD33-calicheamycin) for patients in CR.


2. Patient eligibility criteria



Inclusion criteria

Age 61 years or more
Subjects with a cytopathologically confirmed diagnosis of (a) AML (M0-M2 and M4-M7, FAB classification, appendix A), or (b) with refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-t) with an IPSS score of >=1.5 (appendix B)
Subjects with a secondary AML progressing from antecedent myelodysplasia and biphenotypic leukemia are eligible. Antecedent MDS refers to any antecedent hematological disease of at least 4 month duration
WHO performance status <= 2 (see appendix E)
Written informed consent

Patients who have completed induction cycles I and II are eligible for second randomization if:
they are in complete remission
serum bilirubin <= 2 x normal value
Hematological recovery, i.e. ANC >= 1.5 x 109/l and platelets >= 100 x 109/l
Written informed consent


Exclusion criteria

Previous induction treatment for AML/MDS
Prior chemotherapy within 6 months of study entry
Previous polycythemia rubra vera
Primary myelofibrosis
Blast crisis of chronic myeloid leukemia
AML-FAB type M3 or AML with cytogenetic abnormality t(15;17)
Impaired hepatic or renal function as defined by: - ALT and/or AST > 2.5 x normal value - Bilirubin > 2 x normal value - Serum creatinin > 2 x normal value(after adequate hydration) (unless these are most likely caused by AML organ infiltration)
Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, etc.)
Cardiac dysfunction as defined by:
a. Myocardial infarction within the last 6 months of study entry, or
b. Reduced left ventricular function with an ejection fraction <= 50% as measured by MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable)
c. Unstable angina
d. Unstable cardiac arrhythmias


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:



Name institute
Name of caller/physician who treats the patient
Name or initials of patient
Hospital record number
Sex
Date of birth
Eligibility criteria

For the second randomisation the following information is required:
Protocol number
Name institute
Name of caller/responsible investigator
Patient's study number
Eligibility criteria


4. Participating parties



Principal investigator

B Lowenberg (lowenberg@hema.fgg.eur.nl)


Coordinating investigator(s)

GJ Ossenkoppele (g.ossenkoppele@azvu.nl)
MA Boogaerts


Statistician(s)

Y. van Norden (y.vannorden@erasmusmc.nl)


Trial manager

P. Cornelisse (p.cornelisse@erasmusmc.nl)


Central data management

P. Cornelisse (p.cornelisse@erasmusmc.nl)
A.C.J. Ammerlaan (a.c.j.ammerlaan@erasmusmc.nl)


Other functions

Central Cytogeneticist:
Drs. K. Gerssen-Schoorl
Dr. E. van den Berg(E.van.den.Berg-de.Ruiter@medgen.azg.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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