HOVON HO42 AML

Closed

Main info

Identifier:
HO42 AML
Sponsor:
HOVON
Working group party:
Leukemia
Age:
18-60
Stage:
1st Line
Echelon:
Limited Site Selection
Included patients:
1018
(of 800)
Active sites:
37
(of 38)
Title:

Randomized induction and post induction therapy in adult patients (<= 60 yrs of age) with acute myelocytic leukemia (AML) or refractory anemia with excess of blasts (RAEB, RAEB-t) with IPSS score >= 1.5

Timeline

Scheduled
Actual
2000
30 Jun
Opportunity
2000
29 Nov
EC Approval
2000
29 Nov
EC Approval
2001
02 Jan
FPI
2001
02 Jan
First Site
2001
02 Jan
First Site
2001
02 Jan
Activated
2001
17 Jan
FPI
2006
18 Jul
Endpoint Analysis
2007
15 Feb
ClosedForInclusionActualStart
2010
31 May
Endpoint Analysis

News

The HO42 AML study has been published in the New England Journal of Medicine. This resulted in a lot of media attention, please find a selection of the publications here.

Flow

Flow

Details

Phase:
Select:
Monitoring Type:
Not any more
Objectives:
  • To study in a randomized comparison the use of granulocyte-colony stimulating factor (GCSF) for priming during induction cycles I and II as regards the complete remission rate, disease free survival, risk of relapse and overall survival.
  • To evaluate the outcome of allogeneic sibling SCT in intermediate risk patients and compare the results with those after chemotherapy and ablation + PBSCT
  • To assess the value of early allogeneic family donor and unrelated donor SCT in patients with poor risk AML in comparison to the results in those treated with chemotherapy and ablation + PBSCT
  • To determine the prognostic value of molecular markers and gene expression profiles of the leukemia assessed at diagnosis
  • To assess minimal residual disease following therapy by standardized sampling of marrow/blood

Eligibility

Inclusion Criteria:
  • Age 18-60 years (incl.)
  • 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)

  • Patients with therapy-related AML/RAEB/RAEB-t are eligible provided they have not received chemotherapy during the past 6 months. Also patients with biphenotypic leukemia may be included.
  • Subjects with a secondary AML progressing from antecedent myelodysplasia are eligible. Antecedent MDS refers to a condition of at least 4 month duration
  • WHO performance status ≤ 2 (see appendix E)
  • Written informed consent
Exclusion Criteria:
  • Prior chemotherapy within 6 months of study entry
  • Relapse of AML or MDS after induction chemotherapy
  • Prior stem cell transplant
  • Previous polycythemia rubra vera
  • Primary myelofibrosis
  • Blast crisis of chronic myeloid leukemia
  • AML-FAB type M3 or AML with cytogenetic abnormality t(15;17) or AML with a PML/RAR alpha or a variant RAR alpha fusion gene
  • Impaired hepatic or renal function as defined by:
    • ALT and/or AST > 3 x normal value
    • Bilirubin > 3 x normal value
    • Serum creatinin > 3 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:
    • Myocardial infarction within the last 6 months of study entry, or
    • Reduced left ventricular function with an ejection fraction <50% as measured by MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable)
    • Unstable angina
    • Unstable cardiac arrhythmias
  • Pregnancy

Registration Details

Eligible patients should be registered immediately after diagnosis (on the basis of cytological examination of marrow and blood smears in the participating center), and before the start of chemotherapy. Patients can be registered at the HOVON Data Center of the Erasmus MC – Daniel den Hoed by phone call: +31.10.4391568 or fax +31.10.4391028 Monday through Friday, from 09:00 to 17:00, or via the Internet through TOP (Trial Online Process; https://www.hdc.hovon.nl/top). A logon to TOP can be requested at the HOVON Data Center for participants.

The following information will be requested at registration:

  • Protocol number
  • Institution name
  • Name of caller/responsible investigator
  • Patient’s initials or code
  • Patient’s hospital record number
  • Sex
  • Date of birth
  • Date of diagnosis of AML or RAEB or RAEB-t
  • WHO performance status
  • White blood cell count (WBC)
  • FAB type of AML or RAEB or RAEB-t
  • Eligibility criteria (see 8.1.1 and 8.1.2)
  • Prior hematological or oncological disease
  • Previous chemotherapy or radiotherapy

Participating Sites

Ziekenhuizen die deelnemen aan het onderzoek staan benoemd op de HOVON website bij het onderzoek. Het kan zijn dat uw ziekenhuis niet genoemd wordt, maar wel aan het onderzoek deelneemt. Informeer hiernaar bij uw arts.

Site
37 results
Order by
Accrual rate
Activation date
NL-Rotterdam-EMCDANIEL
92
17 Jan 2001
NL-Amsterdam-VUMC
73
24 Jun 2001
CH-Zürich-USZ
70
25 Oct 2001
BE-Leuven-UZLEUVEN
69
04 May 2001
NL-Groningen-UMCG
69
13 Mar 2001
NL-Rotterdam-ERASMUSMC
66
19 Jan 2001
CH-Bern-INSEL
64
10 Aug 2001
NL-Maastricht-MUMC
49
27 Jun 2001
DE-Mainz-KLINKUNIMAINZ
45
18 Apr 2001
NL-Utrecht-UMCUTRECHT
43
19 Jun 2001
NL-Amsterdam-AMC
43
02 Apr 2001
CH-Basel-USB
36
15 Nov 2001
NL-Enschede-MST
35
15 Oct 2001
BE-Bruxelles-STLUC
30
19 Apr 2001
BE-Yvoir-MONTGODINNE
30
19 Jun 2001
CH-Luzern-LUKS
25
21 May 2002
NL-Nieuwegein-ANTONIUS
22
07 Jun 2001
NL-Zwolle-ISALA
21
29 Mar 2001
CH-St. Gallen-KSSG
16
11 Jun 2001
NL-Den Haag-HAGA
16
05 Mar 2001
CH-Aarau-KSA
16
06 Jul 2001
NL-Amersfoort-MEANDERMC
15
17 Apr 2001
CH-Lausanne-CHUV
11
02 May 2002
BE-Haine-Saint-Paul-JOLIMONT
10
24 Aug 2001
NL-Heerlen-ATRIUMMC
9
21 May 2003
BE-Roeselare-AZDELTA
8
24 Dec 2012
DE-Frankfurt am Main-NORDWEST
6
02 Mar 2001
CH-Bellinzona-SANGIOVANNI
6
10 Jan 2003
CH-Geneve (14)-HCUGE
5
06 Jul 2001
NL-Rotterdam-SFG
5
11 Nov 2002
BE-Gilly-STJOSEPHGILLY
5
02 Feb 2001
NL-Amsterdam-OLVG
4
12 Mar 2003
CH-Neuchatel-HNE
3
26 Oct 2001
CH-Winterthur-KSW
1
13 Aug 2003
NL-Leiden-LUMC
BE-Antwerpen-ZNASTUIVENBERG
30 Mar 2010
BE-Liege-CHRCITADELLE
= Active hospitals
= Inactive hospitals

Participating Parties

Downloads

Up