HOVON HO89 AML

Closed

Main info

Identifier:
HO89 MDS
Sponsor:
HOVON
Working group party:
Leukemia
Age:
>= 18
Stage:
1st Line
Echelon:
Level D
Included patients:
200
(of 200)
Active sites:
60
(of 46)
Title:

A Phase II randomized multicenter study to assess the efficacy of lenalidomide with or without erythropoietin and granulocyte-colony stimulating factor in patients with low and intermediate-1 risk myelodysplastic syndrome.

Timeline

Scheduled
Actual
2008
30 Jan
Opportunity
2009
18 Mar
EC Approval
2009
31 Mar
First Site
2009
06 May
EC Approval
2009
27 May
Activated
2009
27 May
First Site
2009
29 May
FPI
2015
12 Aug
ClosedForInclusionActualStart
2018
01 Nov
Endpoint Analysis

News

12 August 2015: The HOVON 89 MDS study is closed for entry of new patients, because it has reached its target of 200 patients.

Updated documents:
30 November 2018: New version of SAE and SPM forms and new CRF (23 October 2018) is available
31 October 2018: New version of WMO is available
09 January 2015: Protocol version 02 October 2014 and new version Patient Information & IC form
04 March 2014: New version 'Overview labinvestigations' (address change HOVON Data Center)
04 March 2014: New version site document checklist and HRF (new address HOVON Data Center)

Flow

Flow

Details

Phase:
Prospective Phase II study
Monitoring Type:
Not any more
Objectives:

Primary objective

  • To evaluate the efficacy of lenalidomide (RevlimidTM) in low/int-1 risk MDS with or without a treatment with Epo (NeoRecormonTM)/G-CSF (NeupogenTM) in terms of hematological improvement (HI) as defined by the modified response criteria of the IWG for MDS [40], see appendix C.

Secondary objectives

  • To evaluate the safety and tolerability of lenalidomide (RevlimidTM) in low/int-1 risk MDS with or without Epo (NeoRecormonTM)/G-CSF (NeupogenTM)
  • Time-to-HI and duration-of-HI
  • The number of given treatment cycles per patient and for arm B the number of patients receiving Epo and/or G-CSF
  • The response rate (in terms of CR, PR, including cytogenetic response according to the modified response criteria of the IWG for MDS [40], see appendix C)
  • Progression-Free-Survival (i.e. time from registration to disease progression, including progression to leukemia, or death from any cause)
  • Transfusion requirements of red blood cells

Eligibility

Inclusion Criteria:
  • Patients with MDS classified as
    • RA, RARS and RAEB (with <10% myeloid blasts), CMML (with <10% myeloid blasts), according to FAB (see appendix A3) or
    • RA, RARS, RCMD, RCMD-RS, RAEB-1, MDS-U according to WHO (see appendix A1) or
    • patients with MPD/MDS (CMML-1 according to WHO) with a WBC ≤ 12x10^9/l (see appendix A2)

with an IPSS ≤ 1.0 (see appendix B1)

  • Hb ≤ 6.2 mmol/l (10.0 g/dl)

or Hb ≤ 7.2 mmol/l and ANC ≤ 1.0x10^9/l
or red blood cell transfusion dependent (≥ 2 units RBC during at least 8 weeks; units must be given for a Hb ≤ 5.6 mmol/l)

  • Age ≥ 18 years
  • WHO performance status 0-2 (see appendix D)
  • Patient not previously treated with Epo/G-CSF, or failure of response or relapse after hematological improvement or disease progression to maximal RAEB-1 after previous therapy with Epo/G-CSF
  • Serum creatinin < 150 μmol/l
  • Serum billirubin < 25 μmol/l and ASAT, ALAT and Alkaline phosphatase < 2.5 times the upper limit of normal, except if related to disease
  • The patient must give written informed consent
  • Negative pregnancy test within 7 days prior to start of study drug, if applicable.
  • Patient (all men, pre-menopausal women) agrees to use adequate contraceptive methods.
  • Serum erythropoietin level
    • > 200 U/l or
    • ≤ 200 U/l if failure of response or loss of hematological improvement or disease progression to maximal RAEB-1 after prior standard therapy with Epo/G-CSF; Epo/G-CSF should be stopped at least 1 month before randomization.
Exclusion Criteria:
  • Severe cardiac, pulmonary, neurologic, metabolic or psychiatric diseases or active malignancies.
  • Anemia due to other causes than MDS including iron, B12 and folate deficiencies, autoimmune hemolysis and/or paroxysmal noctural hemoglobinuria (PNH)
  • Hypoplastic MDS
  • High predictive score (score 0 or 1) to respond on standard treatment with Epo/G-CSF according to guidelines; see appendix H
  • Active uncontrolled infection
  • Absolute neutrophil count (ANC) < 0.5x10^9/l
  • Patients dependent on platelet transfusions or with platelet counts < 25x10^9/l or patients with active bleeding
  • Patients treated with biological response modifiers (i.e. growth factors, immunosuppressive agents and/or chemotherapy) within 1 month prior to randomization
  • Lactating women
  • Prior treatment with lenalidomide
  • Prior CTCAE ≥ grade 3 allergic reaction/hypersensitivity to thalidomide
  • Prior CTCAE ≥ grade 3 rash/blistering while taking thalidomide
  • Prior CTCAE ≥ grade 3 allergic/hypersensitivity to Epo and/or G-CSF

Registration Details

Eligible patients should be randomized before start of treatment. Patients need to be registered at the HOVON Data Center of the Erasmus MC Rotterdam – location Daniel den Hoed, via the Internet via TOP (Trial Online Process; https://www.hdc.hovon.nl/top) or by phone call: +31.10.7041560 or fax +31.10.7041028, Monday through Friday, from 09:00 to 17:00 CET. 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
  • Sex
  • Date of birth
  • Date written informed consent
  • ‘Risk Management Program’ is discussed with patient
  • Approval for central tissue review
  • Approval for blood and/or bone marrow storage for scientific research
  • Presence of cytogenetic abnormalities
  • MDS diagnosis (FAB and/or WHO)
  • Eligibility criteria

Final analysis for manuscript (Q2/Q3-2020)

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
60 results
Order by
Accrual rate
Activation date
NL-Amsterdam-VUMC
19
06 May 2009
NL-Groningen-UMCG
13
14 Oct 2009
NL-Amersfoort-MEANDERMC
13
23 Nov 2009
NL-Nijmegen-RADBOUDUMC
12
16 Feb 2010
NL-Rotterdam-ERASMUSMC
9
20 Jul 2009
NL-Zwolle-ISALA
9
25 Aug 2009
NL-Enschede-MST
8
12 Feb 2010
NL-Deventer-DZ
7
16 Nov 2009
NL-Hilversum-TERGOOI
7
13 Nov 2009
NL-Rotterdam-EMCDANIEL
7
14 Aug 2009
NL-Nieuwegein-ANTONIUS
7
08 Oct 2010
NL-Sittard-Geleen-ZUYDERLAND
5
13 Jan 2010
NL-Den Haag-HAGA
5
12 Aug 2009
NL-Hoorn-DIJKLANDERHOORN
5
28 Oct 2009
NL-Goes-ADRZ
5
01 Oct 2010
NL-Dirksland-VANWEELBETHESDA
4
09 Nov 2009
NL-Helmond-ELKERLIEK
4
12 Apr 2012
NL-Apeldoorn-GELREAPELDOORN
4
29 Jun 2009
NL-Haarlem-SPAARNEHAARLEM
4
11 Oct 2011
NL-Amsterdam-AMC
4
07 Jul 2009
NL-Breda-AMPHIA
4
07 Dec 2009
NL-Gouda-GROENEHART
4
28 Jun 2010
NL-Capelle a/d IJssel-YSL
3
03 Oct 2011
NL-Hoofddorp-SPAARNEGASTHUIS
3
01 Jul 2009
NL-Eindhoven-MAXIMAMC
3
02 Jun 2010
NL-Leiden-LUMC
3
15 Dec 2010
NL-Amsterdam-SLOTERVAART
3
01 Oct 2009
NL-Amsterdam-SLAZLUCAS
2
10 Dec 2009
NL-Almere-FLEVOZIEKENHUIS
2
01 Sep 2009
NL-Den Bosch-JBZ
2
23 Mar 2010
NL-Ede-ZGV
2
08 Nov 2011
NL-Rotterdam-MAASSTADZIEKENHUIS
2
28 Jun 2010
NL-Delft-RDGG
2
23 Nov 2009
NL-Leeuwarden-MCL
2
04 Jan 2011
NL-Maastricht-MUMC
2
07 Oct 2010
NL-Arnhem-RIJNSTATE
1
31 Jul 2009
NL-Terneuzen-ZORGSAAM
1
30 Sep 2013
NL-Amsterdam-OLVG
1
18 Jun 2010
NL-Roermond-LZR
1
05 Aug 2010
NL-Beverwijk-RKZ
1
20 Jan 2010
NL-Heerlen-ATRIUMMC
1
03 Feb 2010
NL-Schiedam-FRANCISCUSVLIETLAND
1
07 Feb 2011
NL-Nijmegen-CWZ
1
10 Oct 2013
NL-Eindhoven-CATHARINA
1
23 Jan 2013
NL-Amstelveen-AMSTELLAND
1
09 Nov 2010
NL-Purmerend-DIJKLANDERPURMEREND
NL-Geldrop-STANNA
27 Sep 2010
NL-Doetinchem-SLINGELAND
NL-Uden-BERNHOVEN
06 Mar 2012
NL-Tiel-RIVIERENLAND
NL-Venlo-VIECURI
23 Sep 2010
NL-Drachten-NIJSMELLINGHE
23 Jun 2010
NL-Zutphen-GELREZUTPHEN
07 Jul 2014
NL-Tilburg-ETZ
29 Oct 2010
NL-Alkmaar-NWZ
NL-Leidschendam-HMCANTONIUSHOVE
NL-Dordrecht-ASZ
30 Jun 2009
NL-Roosendaal-BRAVIS
09 Nov 2010
NL-Winterswijk-SKBWINTERSWIJK
10 Mar 2010
NL-Hardenberg-SAXENBURGH
= Active hospitals
= Inactive hospitals

Participating Parties

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