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Clinical picture: MDS (Myelo-dysplastic Syndrome)

Trial: HOVON 89 MDS


News
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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News


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.

 

28-11-2012

IPSS score:

During randomization the IPSS score will be calculated automatically. While filling in the registration form a default value (0.5) is visible. Please do not overwrite this value. The calculated IPSS score will be visible after randomization. In case of problems please contact the HOVON Data Center.

 

Updated documents:

18 July 2017: Updated CRF version and new version of SAE form is available

09 January 2017: Updated CRF version 16 December 2016

20 September 2016: New version of WMO is available

01 March 2016: Updated CRF version 01 March 2016

09 January 2015: Protocol version 02 October 2014 and new version Patient Information & IC form

09 January 2015: New version of SAE form is available

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)

07 November 2012: New version of SPM CRF.

25 June 2012: New CRF version (complete set)

09 May 2012: Protocol version 14 December 2011 and new version Patient Information & IC form

 

New documents:

24 July 2014: New version of SAE form is available.

23 July 2013: New version 'medication order form' is available.

06 June 2013: 'Statement of expenses form' (new roomnumber) available under heading 'news'.

09 May 2012: Newsletter 5 is available under heading 'news'.

HOVON 89 RMP is available under heading 'other documents'.


1. Overview



Summary

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


Status

closed



Study details



Type of study

Prospective randomized Phase II study


Echelon level

Level D


Type of monitoring for this study

Site evaluation visits


Target number of patients

200


Current number of patients

184


Date of activation

27-May-2009


Date closed

12-Aug-2015


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)
Progression-Free-Survival
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



Registration

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...: http://www.hdc.hovon.nl/top


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)


Co-Investigator(s)

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


Statistician(s)

Mw. Dr.ir 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)
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 - Mw. D. Olde Weghuis (Medisch Spectrum Twente)
Reviewer - Cytogenetics - Mw. S. Snijder (AMC)
Reviewer - Cytogenetics - Mw. Dr. M.J.P.L. Stevens-Kroef (Radboudumc)
Reviewer - HRC - HRC (Erasmus MC - Daniel)


Statistician(s)

D. Chitu (d.chitu@erasmusmc.nl)


Trial manager

H.A. Visser-Wisselaar (h.visser-wisselaar@erasmusmc.nl)


5. Participating sites



Site
Included patients *
NL-Almere-Flevoziekenhuis
2
NL-Amersfoort-Meander MC
12
NL-Amstelveen-Ziekenhuis Amstelland
1
NL-Amsterdam-AMC
3
NL-Amsterdam-OLVG
1
NL-Amsterdam-Sint Lucas Andreas ZH, Lucas
2
NL-Amsterdam-Slotervaart Ziekenhuis
3
NL-Amsterdam-VUMC
19
NL-Apeldoorn-Gelre ziekenhuizen, Apeldoorn
4
NL-Arnhem-Ziekenhuis Rijnstate
1
Show 44 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


 Protocol



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