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Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON 138 APL


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


HO138 News

Due to an expired medication batch the HO138 study is 'on hold'.

 

Direct link to MACRO database:

https://macro4.medizin.tu-dresden.de
 
20-AUG-2019

Update from the sponsor (TU Dresden):

We (Sponsor TU Dresden) recently received good news from TEVA and the involved distributor ALMAC that we would like to share with you.

We can re-start the recruitment for the APOLLO-trial at the end of September 2019. At the end of September there will be 13.000 ampoules of IMP available which is enough to provide all participating trial sites in Europe with a new stock of medication (2 boxes for each pharmacy) and to include and treat potential patients in Europe. These 13.000 ampoules will be labelled with the still approved single label system and will give us the chance to re-start the recruitment earlier than anticipated. Further IMP will be labelled with a new booklet label system, which ensures more flexibility and shorter delivery times in the future. We haven’t yet received the final template of the booklet label, which will have to be submitted by all countries when available but we should receive it within the next 2 weeks.

Before restarting recruitment a substantial amendment needs to be submitted by all countries – this will include several changes in terms of IMP manufacturing, including the new label form mentioned above.


1. Overview



Summary

A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA
and idarubicin versus standard ATRA and anthracycLine-based chemotherapy (AIDA
regimen) for patients with newLy diagnosed, high-risk acute prOmyelocytic leukemia (APOLLO)


Status

planned


Members

participating groups: SAL, AML-CG, AML-SG, OSHO, PETHEMA, French-Belgian-Swiss APL group, HOVON, GIMEMA



Study details



Type of study

Prospective randomized Phase III study


Echelon level

Limited site selection


Type of monitoring for this study

Site evaluation visits


Target number of patients

280


Date of first EC&CA submission

02-May-2017


Date of activation

26-Apr-2018


Approved by

METc UMCG


Study objectives

Primary endpoint:
The primary endpoint of the study is event-free survival.

Secondary endpoints of the trial:
Rate of hematological CR after induction
Rate of early death during induction
Rate of overall survival (OS) at 2 years
Rate of cumulative incidence of secondary myelodysplasia or leukemia
Rate of cumulative incidence of relapse (CIR) at 2 years
Incidence of hematological and non-hematological toxicity
Rate of molecular remission after last consolidation cycle
Assessment of PML/RARA transcript level reduction during treatment
To investigate differences in the following an priori Quality of Life selected scales: physical and cognitive functioning as well as fatigue, nausea and vomiting, constipation and appetite loss
To investigate differences in the immune reconstitution between the two arms
Total hospitalization days during therapy and health economic impact


2. Patient eligibility criteria



Inclusion criteria

Informed consent
Women or men with a newly diagnosed APL by cytomorphology, confirmed by molecular analysis*
Age ≥18 and ≤ 65 years
ECOG performance status 0-3
WBC at diagnosis > 10 GPt/l
Serum total bilirubin ≤ 3.0 mg/dl (≤ 51 μmol/l)
Serum creatinine ≤ 3.0 mg/dl (≤ 260 μmol/l)
Women must fulfill at least one of the following criteria in order to be eligible for trial inclusion:
o Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with Serum FSH > 40 U/ml)
o Postoperative (i.e. 6 weeks) after bilateral ovariectomy with or without hysterectomy
o Continuous and correct application of a contraception method with a Pearl
o Index of <1% (e.g. implants, depots, oral contraceptives, intrauterine device IUD).
o Sexual abstinence
o Vasectomy of the sexual partner


Exclusion criteria

Patients who are not eligible for chemotherapy as per discretion of the treating physician
APL secondary to previous radio- or chemotherapy for non-APL disease
Other active malignancy at time of study entry (exception: basal-cell carcinoma)
Lack of diagnostic confirmation of APL at genetic level (*see above)
Significant arrhythmias, ECG abnormalities:
o Congenital long QT syndrome;
o History or presence of significant ventricular or atrial tachyarrhythmia;
o Clinically significant resting bradycardia (<50 beats per minute)
o QTc >500msec on screening ECG for both genders (using the QTcF formula detailed on protocol)
o Right bundle branch block plus left anterior hemiblock, bifascicular block
Other cardiac contraindications for intensive chemotherapy (L-VEF <50%)
Uncontrolled, life-threatening infections
Severe non controlled pulmonary or cardiac disease
Severe hepatic or renal dysfunction
HIV and/or active hepatitis infection
active multiple sclerosis (patients with inactive MS can be included)
Pregnant or breast-feeding patients
Allergy to trial medication or excipients in study medication
Substance abuse; medical, psychological or social conditions that may interfere with
the patients participation in the study or evaluation of the study results
Use of other investigational drugs at the time of enrolment or within 30 days before study entry


3. Registration (& randomization) of patients



4. Participating parties



5. Participating sites



Site
Included patients *
BE-Antwerpen-ZNA Stuivenberg
0
BE-Yvoir-Cliniques Universitaires de Mont-Godinne
0
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
0
NL-Groningen-UMCG
0
NL-Maastricht-AZ Maastricht
0
NL-Nieuwegein-Antonius Ziekenhuis
0
NL-Rotterdam-Erasmus MC
0
NL-Zwolle-Isala
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


 Protocol



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