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Clinical picture: MDS (Myelo-dysplastic Syndrome)

Trial: HOVON 89 MDS

1. Overview
Study details
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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HO89 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)



1. Overview


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



Study details

Type of study

Prospective randomized Phase II study

Echelon level

Level D

Echelon level specification

Level D

Type of monitoring for this study

Site evaluation visits

Target number of patients


Current number of patients


Date of activation


Date closed


Approved by

EudraCT nr.: 2008-002195-10
CKTO: 2008-4333
MEC: METC VUMC, 2009/50

Change history / amendement

AM 1 (sites) approved by central METC (VUMC)
AM 2 (sites) approved by central METC (VUMC)
AM 3 (sites) approved by central METC (VUMC)
AM 4 (protocol & ICF) approved by central METC
AM 5 (sites) approved by central METC (VUMC)
AM 6 (sites) approved by central METC (VUMC)
AM 7 (protocol & ICF) approved by central METC
AM 8 (sites) submitted 12-08-2015

Study objectives

Primary objective:
To evaluate the efficacy of lenalidomide (Revlimid) in low/int-1 risk MDS with or without a treatment with Epo (NeoRecormon)/G-CSF (Neupogen) in terms of Hematological Improvement (HI) as defined by the modified response criteria of the IWG 2006.
Secondary objectives:
To evaluate the safety and tolerability of lenalidomide (Revlimid) in low/int-1 risk MDS with or without Epo (NeoRecormon)/G-CSF (Neupogen)
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)
Transfusion requirements of red blood cells

2. Patient eligibility criteria

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 ≤ 12x109/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 ≤ 1.0x109/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. Note: any cytogenetic karyotype can be included (normal and abnormal (including del(5q) abnormalities).

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, auto-immune 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) < 0.5x109/l.
Patients dependent on platelet transfusions or with platelet counts < 25x109/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.

3. Registration (& randomization) of patients


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...:

Registration criteria

The following information will be requested:

1. Protocol number
2. Institution name
3. Name of caller/responsible investigator
4. Sex
5. Date of birth
6. Date written informed consent
7. Presence of consent for central tissue review and blood / bone marrow samples for side studies
8. Presence of cytogenetic abnormalities
9. MDS diagnosis (FAB and/or WHO)
10. Eligibility criteria

4. Participating parties

Principal Investigator(s)

Prof. Dr. A.A. van de Loosdrecht (VUMC)


Mw. Dr. G.E. de Greef (Erasmus MC - Daniel)
Mw. Dr. P. Muus (Radboudumc)
Dhr. Dr. P.W. Wijermans (Hagaziekenhuis, locatie Leyweg)


Mrs. Dr. D. Chitu (Erasmus MC - Daniel)

Central Data Manager(s)

Mw. S. Cunha (Erasmus MC - Daniel)

Monitor - Site Evaluation Visits

Mw. T. van de Klundert (Erasmus MC - Daniel)
Mrs. M. Spaans (Erasmus MC - Daniel)

Other functions

Central Coordinator - Special Investigations - Mw. Dr. C. Alhan (VUMC)
Central Coordinator - Special Investigations - Dr. E. Cremers (VUMC)
Reviewer - Cytogenetics - Dhr. D. Olde Weghuis (Medisch Spectrum Twente)
Reviewer - Cytogenetics - Drs. mw. S. Snijder (UMC Utrecht)
Reviewer - Cytogenetics - Mw. Dr. M.J.P.L. Stevens-Kroef (Radboudumc)
Reviewer - HRC - HRC (Erasmus MC - Daniel)


D. Chitu (

Trial manager

H.A. Visser-Wisselaar (

Other functions

Please contact monitors at

5. Participating sites

Included patients *
NL-Amersfoort-Meander MC
NL-Amstelveen-Ziekenhuis Amstelland
NL-Amsterdam-Sint Lucas Andreas ZH, Lucas
NL-Amsterdam-Slotervaart Ziekenhuis
NL-Apeldoorn-Gelre ziekenhuizen, Apeldoorn
NL-Arnhem-Ziekenhuis Rijnstate
Show 37 more...
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos

7. Download documentation / forms


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