HOVON HO43 AML

Gearchiveerd

Main info

Identificatie:
HOVON 43 AML
Sponsor:
HOVON
Age:
> 60
Stadium:
1st lijn
Echelon:
Limited Site Selection
Included patients:
866
Active sites:
42
(of 44)
Title:

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)

Timeline

Scheduled
Actual
2000
09 okt.
Activated
2000
09 okt.
EC Approval
2000
27 okt.
First Site
2000
27 okt.
FPI
2006
09 jun.
ClosedForInclusionActualStart
2016
09 jun.
Closeout in Progress
2017
01 mrt.
Archived

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.

Flow

Flow

Details

Phase:
Prospective randomized Phase III study
Monitoring Type:
Not any more
Objectives:

Eligibility

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

Participating Sites

Site
41 results
Order by
Accrual rate
Activation date
BE-Leuven-UZLEUVEN
69
NL-Rotterdam-EMCDANIEL
62
NL-Rotterdam-ERASMUSMC
42
NL-Amsterdam-VUMC
41
NL-Maastricht-MUMC
38
BE-Yvoir-MONTGODINNE
34
NL-Amsterdam-AMC
31
NL-Utrecht-UMCUTRECHT
31
BE-Bruxelles-STLUC
30
NL-Groningen-UMCG
29
CH-Basel-USB
26
DE-Ulm-UNIKLINKULM
25
CH-Bern-INSEL
25
DE-Bonn-UNIBONN
24
NL-Zwolle-ISALA
23
NL-Den Haag-HAGA
21
NL-Enschede-MST
21
DE-Homburg-UNIKLINIKSAARLAND
19
NL-Nieuwegein-ANTONIUS
18
DE-Stuttgart-KLINIKUMSTUTTGART
18
CH-Aarau-KSA
14
CH-Geneve (14)-HCUGE
12
NL-Amersfoort-MEANDERMC
12
BE-Roeselare-AZDELTA
11
CH-Luzern-LUKS
11
BE-Haine-Saint-Paul-JOLIMONT
8
NL-Heerlen-ATRIUMMC
8
DE-München-IRZTUM
8
NL-Dordrecht-ASZ
8
CH-Lausanne-CHUV
8
DE-Hamburg-ASKLEPIOS
7
BE-Gilly-STJOSEPHGILLY
7
DE-Karlsruhe-KLINIKUMKARLSRUHE
6
UK-Cardiff-UHW
4
NL-Amsterdam-OLVG
3
DE-Oldenburg-KLINIKUMOLDENBURG
3
DE-Frankfurt am Main-NORDWEST
3
UK-Manchester-CHRISTIE
1
DE-Mainz-UNIMEDIZINMAINZ
CH-Bellinzona-IOSI
AT-Vienna-HANUSCH
= Active hospitals
= Inactive hospitals

Participating Parties

Downloads

Up