sluit venster

Log in

Gebruikersnaam Wachtwoord Gebruikersnaam en/of wachtwoord vergeten? Gebruikersnaam en wachtwoord aanvragen

Zoek in de HOVON website

Let op!
Mogelijk ziet u niet alle beschikbare info op deze pagina, omdat u niet bent ingelogd, of omdat u niet de juiste privileges heeft.

Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON 138 APL (APOLLO)


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


return to top

News


No news


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



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


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



6. Instruction videos



7. Download documentation / forms




return to top