HOVON HO42A AML

Closed

Main info

Identifier:
HO42(A) AML
Sponsor:
HOVON
Working group party:
Leukemia
Age:
18-60
Stage:
1st Line
Echelon:
Limited Site Selection
Included patients:
518
(of 1440)
Active sites:
38
(of 39)
Title:

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

Timeline

Scheduled
Actual
2005
21 Nov
Opportunity
2005
15 Dec
EC Approval
2005
15 Dec
EC Approval
2006
01 Feb
FPI
2006
01 Feb
First Site
2006
01 Feb
First Site
2006
01 Feb
Activated
2006
17 Feb
FPI
2008
15 Oct
ClosedForInclusionActualStart
2009
31 Dec
Endpoint Analysis
2010
31 May
Endpoint Analysis

Flow

Flow

Details

Phase:
Prospective randomized Phase III study
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
    • AML (M0-M2 and M4-M7, FAB classification, appendix A), or
    • 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 ñ 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
  • Patientís initials or code
  • Patientís 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 and08.1.2)
  • 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
38 results
Order by
Accrual rate
Activation date
CH-Zürich-USZ
45
30 Jun 2006
NL-Rotterdam-EMCDANIEL
42
09 Jan 2006
CH-Bern-INSEL
39
05 Apr 2006
NL-Rotterdam-ERASMUSMC
39
09 Jan 2006
NL-Amsterdam-AMC
37
21 Feb 2006
NL-Amsterdam-VUMC
35
17 Feb 2006
NL-Groningen-UMCG
31
02 Jun 2006
BE-Bruxelles-STLUC
27
08 Jun 2006
CH-Basel-USB
22
04 May 2006
NL-Maastricht-MUMC
20
27 May 2006
NL-Den Haag-HAGA
17
14 Jul 2006
NL-Utrecht-UMCUTRECHT
16
28 Mar 2006
CH-Aarau-KSA
16
23 May 2006
BE-Yvoir-MONTGODINNE
16
26 Apr 2006
NL-Enschede-MST
15
21 Feb 2006
NL-Nieuwegein-ANTONIUS
14
02 Mar 2006
CH-Geneve (14)-HCUGE
11
19 Jul 2006
CH-St. Gallen-KSSG
11
15 Jun 2006
NL-Zwolle-ISALA
9
07 Mar 2006
BE-Leuven-UZLEUVEN
9
21 Feb 2007
NL-Amsterdam-OLVG
8
09 Feb 2007
BE-Antwerpen-ZNASTUIVENBERG
6
31 Jan 2007
NL-Leeuwarden-MCL
6
05 Jun 2007
BE-Roeselare-AZDELTA
5
10 Oct 2007
BE-Antwerpen-ZNAMIDDELHEIM
4
17 Aug 2007
NL-Amersfoort-MEANDERMC
4
12 May 2006
CH-Luzern-LUKS
4
06 Sep 2006
NL-Heerlen-ATRIUMMC
3
22 Aug 2007
CH-Bellinzona-SANGIOVANNI
3
13 Sep 2006
CH-Neuchatel-HNE
3
23 Oct 2006
BE-Haine-Saint-Paul-JOLIMONT
1
25 Jul 2006
DE-Frankfurt am Main-NORDWEST
BE-Liege-CHRCITADELLE
13 Feb 2008
CH-Lausanne-CHUV
CH-Winterthur-KSW
BE-Gilly-STJOSEPHGILLY
NL-Rotterdam-SFG
14 Dec 2006
DE-Mainz-KLINKUNIMAINZ
= Active hospitals
= Inactive hospitals

Participating Parties

Downloads

Up