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Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON 116 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


HO116 Amendement 03 approved in NL

21SEP16:

Amendment 03 approved by EC Netherlands. Please send in requested forms (site documents checklist, ICF + protocol signature page).

BE: all Belgium sites temporarily closed for inclusion of new patients until amendment has been approved in Belgium.

 

Current dose levels:

Patients 1-100: Panobinostat 20 mg/day on days 1, 4, 8 and 11 of each treatment cycle, and Decitabine 1 dd of 10 mg/m2 on day 1, 2 and 3 of each treatment cycle.

Patients 101-above: Panobinostat 20 mg/day on days 1, 4, 8 and 11 of each treatment cycle

 

Please note that currently both poor and very poor risk patients can be included.

 

- August 26, 2015

Based on the decision rules as defined in the protocol the dose level has been deescalated.

As from now, patients will be treated according to dose level 2reduced (see above).

 

Patients who have already started treatment on dose level 1 or 2 should continue in dose level 1 or 2.

Patients who are included at dose level 1 or 2 but did not start panobinostat/decitabine treatment yet, should start treatment at dose level 2reduced.

 

- July 3, 2015

Protocol version 7 has been approved in the Netherlands

 

 - Januari 30, 2015

Based on the decision rules as defined in the protocol the dose level has been escalated.

As from now, patients will be treated according to dose level 2 (see above).

 

Patients who have already started treatment on dose level 1 should continue in dose level 1.

Patients who are included at dose level 1 but did not start panobinostat/decitabine treatment yet, should start treatment at dose level 2.

 

 - March 24, 2014

Central approval for the HOVON 116 AML trial in Belgium has been obtained from the METC UZ Gent.

 

 - November 12, 2013

Central approval for the HOVON 116 AML trial in The Netherlands has been obtained from the METC Erasmus MC Rotterdam.

 


1. Overview



Summary

A phase I/II feasibility study of the combination of panobinostat alone and panobinostat and decitabine prior to donor lymphocyte infusion in recipients of allogeneic stem cell transplantation with poor and very poor-risk AML


Status

open


Members

HOVON



Type of study

Prospective Phase I/II study


Echelon level

Level A


Type of monitoring for this study

Site evaluation visits


Target number of patients

145


Current number of patients

136


Date of activation

29-Nov-2013


Approved by

METC Erasmus MC


Study objectives

Primary objective:
Part I
To asses the safety and feasibility of post-transplant panobinostat combined with decitabine to a regimen of T-cell replete RIC alloHSCT and DLI and select the dose level for part II of the study
Part II
Assess the feasibility and efficacy of post-transplant panobinostat combined with decitabine to a regimen of T-cell replete RIC alloHSCT and DLI in patients with (very) poor-risk AML
Part III
Assess the feasibility and efficacy of post-transplant
panobinostat monotherapy to a regimen of T-cell replete RIC alloHSCT and DLI in patients with (very) poor-risk AML
Secondary objectives:
Assess efficacy in terms of complete remission rate, overall and progression free survival.
Assess toxicity.


2. Patient eligibility criteria



Inclusion criteria

• Patients with poor-risk or very poor-risk AML or RAEB with IPSS ≥ 1.5 , (see appendix D). During the phase I part only very poor-risk patients will be included until demonstrated feasibility in 5 patients receiving combination therapy, thereafter also poor-risk can be included.
• Eligibility for continuation with intensive induction/consolidation chemotherapy
• Eligible for allogeneic donor search (related/unrelated)
• 18-70 years, inclusive
♦ Negative serum pregnancy test for female patients of childbearing potential, at registration
♦ Female patients of childbearing potential must use an effective contraceptive method during
the study and for a minimum of 6 months after study treatment
• Written informed consent


Exclusion criteria

• History of active malignancy during the past 2 years with the exception of basal carcinoma of the skin or carcinoma “in situ” of the cervix or breast
• Known HIV-positivity
• Pregnant or breast-feeding female patients


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Clinical Trial Center
Erasmus MC - Cancer Institute
Postbus 2040
3000 CA Rotterdam
Phone number: +31.10.7041560 (working days 9.00 - 17.00)
Fax number: +31.10.7041028
TOP address: https://www.hdc.hovon.nl/top


Registration criteria

The following information will be requested:



Protocol number
Institution name
Name of caller/responsible investigator
Sex
Date of birth
Date of diagnosis of AML or RAEB
Date written informed consent
Eligibility criteria


4. Participating parties



Principal Investigator(s)

Prof.dr. J.J. Cornelissen (Erasmus MC - Daniel)


Co-Investigator(s)

Mw. dr. M. Jongen-Lavrencic (Erasmus MC - Daniel)
Mw. Dr. E. Meijer (VUMC)
Prof. Dr. G.J. Ossenkoppele (VUMC)


Coordinating Investigator(s)

Dhr. Dr. D.A. Breems (ZNA Stuivenberg)


Statistician(s)

Mw. Dr.ir. Y. van Norden (Erasmus MC - Daniel)


Monitor - Site Evaluation Visits

Dhr. T. Volker (Erasmus MC - Daniel)


Other functions

Central Coordinator - MRD - MRD coordination center (VUMC)
Reviewer - HRC - HRC (Erasmus MC - Daniel)


5. Participating sites



Site
Included patients *
BE-Antwerpen-ZNA Stuivenberg
4
BE-Gent-UZ Gent
0
BE-Leuven-UZ Gasthuisberg
4
NL-Amsterdam-AMC
0
NL-Amsterdam-VUMC
42
NL-Maastricht-AZ Maastricht
27
NL-Rotterdam-Erasmus MC - Daniel
59

* 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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