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Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON 97 AML


News
1. Overview
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


HO97 news

- 26OCT2016: 1 December 2016 the HOVON 97 study is going to be closed for the inclusion of new patients.

Please read the following letter form the PI, Prof. Dr. G.A. Huls:

 

Dear colleagues,

 

Thank you for your interest and support of the HOVON 97 study during the last years. Currently, 116 patients have been included. As discussed at the last HOVON leukemia group meeting, it has been decided to stop the study, mainly due to slow accrual and also because it has become clear that the number of events (especially after 1 year follow up) is low and therefore, the number of events as defined in the original statistical plan will not be reached (also not if more patients will be included).

 

In line with this we would like to announce that the HOVON 97 study will be closed for inclusion December 1st 2016. After additional follow up the study will be analyzed June/July 2017, to be able to submit an abstract to ASH 2017.

 

Best regards, Gerwin Huls

 

 

- 03JAN2012: The first amendment to the protocol has been approved by the central METC (UMCG). Please find the updated protocol below. Also the CRF instructions has been updated, for of the data management in favor of the interim analysis.

 

- 02DEC2011: An interim analyse has been planned for the first 40 included patients, in March 2013.

 

- 12APR2011: PLEASE FIND A NEW VERSION OF THE CRF and CRF instructions, SAE form and SAE instructions (see 6. Download documentation / forms)

 

- 23JUN2010: The HOVON 97 AML study has been approved for Belgium. Please find the documents for Belgium in the HO97 BELGIUM Portfolio (see Download documentation / forms - Belgium).

 

- 22JUN2010: A 'Verpleegkundig document' is available. This document is according to the UMCG directives. Please check this document before use.- 22JUN2010: A 'Verpleegkundig document' is available. This document is according to the UMCG directives. Please check this document before use.

 

- 18MAR2009: The HOVON 97 AML has been approved by the central METC (UMCG).


1. Overview



Summary

Randomized maintenance therapy with Azacitidine (Vidaza) in older patients (≥ 60 years of age) with acute myeloid leukemia (AML) and refractory anemia with excess of blasts (RAEB, RAEB-t)


Status

open


Members

HOVON



Type of study

Prospective randomized Phase III study


Echelon level

Level C-HIC


Type of monitoring for this study

Site evaluation visits


Target number of patients

126


Current number of patients

117


Date of activation

30-Jun-2009


Approved by

CKS: 2008-4291, 01-JUL-2008
MEC: METC UMCG 2009/044, 18-MAR-2009
EudraCTnr.: 2008-001290-15


Study objectives

To assess, in a randomized study the value of Azacitidine as post remission therapy (in comparison to observation) in elderly patients with AML, RAEB or RAEB-t with respect to the disease free survival.
In addition, post remission Azacitidine therapy will be evaluated with respect to toxicity, probability of relapse and probability of death in first CR and overall survival.
To evaluate prognostic factors (e.g. phenotype, cytogenetics) in the context of post remission therapy with Azacitidine as regards to overall survival, and disease free survival.


2. Patient eligibility criteria



Inclusion criteria

Age 60 years or more
Subjects with a cytopathologically confirmed diagnosis of
(a) AML (M0-M2 and M4-M7, FAB classification, appendix A), or
(b) 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 C)
Note: Subjects with a secondary AML progressing from antecedent myelodysplasia and biphenotypic leukaemia are eligible.
Less than 5% bone marrow blasts and absence of Auer rods after 2 cycles of induction therapy (this induction therapy can be according to HOVON81, HOVON92 or similar protocols. Of note: also patients who are treated according to one of these protocols but were not formally included in these studies are eligible for HOVON97)
Hematological recovery, i.e. ANC ≥ 0.5 x 109/l and platelets ≥ 50 x 109/l
WHO performance status ≤ 2 (see appendix F)
Written informed consent


Exclusion criteria

Extramedullary disease
Planned allogeneic hematopoietic cell transplantation
Previous polycythaemia rubra vera
Primary myelofibrosis
Blast crisis of chronic myeloid leukemia
AML-FAB type M3 or AML with cytogenetic abnormality t(15;17)
Impaired hepatic or renal function as defined by:
􀂃 ALT and/or AST > 2.5 x normal value
􀂃 Bilirubin > 2 x normal value
􀂃 Serum creatinin > 2 x normal value (after adequate hydration)
Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, 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


3. Registration (& randomization) of patients



Registration

Eligible patients should be randomized within 3 months after start of the 2nd cycle of induction therapy.
Patients need to be registered at the HOVON Data Center of the Erasmus MC - Daniel den Hoed
via the internet via Trial Online Process http://www.hdc.hovon.nl/top
or by phone call (+31.10.7041560) (working days 9.00-17.00)
or by fax (+31.10.7041028) (working days 9.00- 17.00)


Registration criteria

The following information will be requested:



Protocol number
Institution name
Name of caller / responsible investigator
Date of birth
Sex
Date of written informed consent
Registered in other HOVON trial (HO81, HO92 or other)
Stratification factors
Specific items patient gives consent for (see ICF)
Eligibility criteria


4. Participating parties



Principal Investigator(s)

Prof. G. Huls (UMCG)


Co-Investigator(s)

Prof. Dr. B. Löwenberg (Erasmus MC - Centrum)
Prof. Dr. G.J. Ossenkoppele (VUMC)
Prof.Dr. E. Vellenga (UMCG)


Coordinating Investigator(s)

Prof. Dr. G.E.G. Verhoef (UZ Gasthuisberg)


Statistician(s)

Mw. Dr.ir D. Chitu (Erasmus MC - Daniel)


Other functions

Reviewer - Cytogenetics - Mw. Dr. E. van den Berg (UMCG)
Reviewer - Cytogenetics - Mw. Dr. H.B. Beverloo (Erasmus MC - Medische Faculteit)
Reviewer - HRC - Mw. Dr. M. Jongen-Lavrencic (Erasmus MC - Daniel)


5. Participating sites



Site
Included patients *
BE-Antwerpen-ZNA Middelheim
1
BE-Antwerpen-ZNA Stuivenberg
4
BE-Bruxelles-Cliniques Universitaires St. Luc
15
BE-Haine-Saint-Paul-Hopital de Jolimont
0
BE-Leuven-UZ Gasthuisberg
2
BE-Liege-Hopital de la Citadelle
6
BE-Roeselare-AZDelta
3
BE-Wilrijk-Sint Augustinus
2
BE-Yvoir-Cliniques Universitaires de Mont-Godinne
5
NL-Amersfoort-Meander MC
4
Show 15 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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