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Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON 145 AML


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


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1. Overview



Status

open


Study details



Type of study

Prospective randomized Phase III study


Echelon level

Level A


Echelon level specification

A


Type of monitoring for this study

Site evaluation visits


Target number of patients

55


Date of first EC&CA submission

14-Dec-2018


Approved by

METC Erasmus MC


Study objectives

Primary

To determine the efficacy of panobinostat maintenance therapy versus standard of care administered to patients with high-risk MDS or AML in complete hematologic remission after an
allogeneic hematologic stem cell transplantation (HSCT)

Secondary

To assess the safety and tolerability of panobinostat maintenance therapy after HSCT compared with standard of care

To evaluate HRQoL of patients under panobinostat maintenance therapy after HSCT

To study the treatment effect in subgroups of patients defined by treatment approach (i.e. HOVON-approach vs. RIC vs MAC conditioning), donor type (HLA-compatible versus haploidentical) and molecular distinct subgroups of AML/MDS


2. Patient eligibility criteria



Inclusion criteria

Inclusion criteria

Adult patients with high-risk AML or MDS as defined above
and
First allogeneic HSCT performed within 30 - 65 days prior to enrollment
Eastern Cooperative Group (ECOG) performance status ≤ 2 (Appendix 6)
Complete hematologic remission or complete hematologic remission with incomplete recovery (see section 14.1) documented by bone marrow aspiration within 14 days prior to randomization
Laboratory test results maximum 14 days prior to randomization within the following ranges:
o Absolute neutrophil count ≥ 1.0 x 109/L
o Platelet count ≥ 75 x 109/L
o Potassium, magnesium and phosphorus within
normal limits
o Serum creatinine clearance ≥ 30 mL/min
o Total bilirubin ≤ 1.5 x ULN
o AST (SGOT) and ALT (SGOT) ≤ 2.5 x ULN
Negative serum pregnancy test (within 14 days prior to enrollment) in women of child-bearing potential (WOCBP)
Written informed consent, willingness and ability to comply with all study procedures


Exclusion criteria

Exclusion criteria

Active acute GvHD grade III-IV according to modified Glucksberg criteria (Appendix 7)
Active acute GvHD grade II or chronic GvHD moderate/severe according to NIH criteria (Appendix 8) requiring systemic corticosteroids > 0.5 mg/kg body weight of methylprednisolone
equivalent or combination immunosuppressive treatment
Uncontrolled or significant heart disease, including recent myocardiac infarction, cardiac failure (NYHA II-IV), unstable angina pectoris, or clinically significant bradycardia
Long QT syndrome
QTcF >= 480 msec on screening ECG to be performed within 14 days prior to enrollment
Concurrent use of medications that have a relative risk of prolonging QT interval or of inducing Torsade de Pointes, if such treatment cannot be discontinued or switched to a different
medication prior to the first dose of study drug (see Table 9).
Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes mellitus, chronic obstructive or chronic restrictive pulmonary disease including dyspnoea at rest
from any cause) or history of serious organ dysfunction or disease involving the heart, kidney, or liver and/or seropositive HIV or HCV .
Serious active infection
CMV reactivation, which is not responsive to first-line valganciclovir or ganciclovir
Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea,
malabsorption syndrome, obstruction, or stomach and/or small bowel resection).


3. Registration (& randomization) of patients



Registration

Registration of patients via the eCRF provided by the sponsor.

https://ctcn.kgu.de/apps/WebObjects/ST21-productive-
DataCapture.woa/wa/choose?customer=HAEM1


4. Participating parties



5. Participating sites



Site
Included patients *
NL-Amsterdam-AMC
0
NL-Rotterdam-Erasmus MC - Daniel
0

* 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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