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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: ALL (Acute Lymphatic Leukemia)

Trial: HOVON 146 ALL

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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HO146 News




Nog te inlcuderen aantal patienten in de HO146 : 5 (24 Sept 15:04 hrs.)

Belangrijk: Alleen patiënten die op de "HO146 screeningslijst" zijn ( m.a.w. patiënt waarbij een
‘’SCR146- letter code ziekenhuis-XXX ‘’nummer is toegekend) komen in aanmerking, om daadwerkelijk door ons geregistreerd te worden in ALEA.
Patientregistratie in ALEA vindt heden uitsluitend plaats via het HOVON Data Center ( HDC)

 23-07-2020: aanpassing in labmanual NL & B,E nieuwe versies beschikbaar op website.


 02-06-2020: aanpassing verzendformulier Central NL&BE, nieuwe versie v2 beschikbaar op de website


20-12-2019: Vanaf heden ( 20 dec 2019)  kunt u nieuwe HO146 patienten direct via ALEA registreren. Het is dus niet langer mogelijk om via TOP te registreren. ALEA regstration patient instructie kunt u onder ''other documents'' vinden op de website.


11-12-2019: Nieuwe versie RegRand  form v2_25NOV2019 geplaatst op de website


15-10-2019: Nieuwe versie labmanual v04 voor Belgie geplaatst op de website, samples versturen via SDX


8-10-2019: Nieuwe versie labmanual v03 voor Belgie geplaatst op de website



De HOVON 146 studie is goedgekeurd voor de Nederlandse sites door de CCMO en de centrale Ethische Commissie van het Erasmus MC. Dit betekent dat u de lokale procedures kunt opstarten.

De benodigde documenten hiervoor kunt u terugvinden bij 7.Download documentation.



1. Overview



 Patienten informatie

Study details

Type of study

Prospective Phase II study

Echelon level

Level A
Level B

Echelon level specification

Level A and B

Type of monitoring for this study

Site evaluation visits

Target number of patients


Date of first EC&CA submission


Date of activation


Approved by

Initital approval
NL: CCMO 14DEC2017

BE: EC UZ Leuven: 3AUG2018

Amendement 1
NL: METC 24OKT2018
NL: CCMO 18SEP2018

BE: EC UZ Leuven: 2APR2019
BE:FAGG: 21DEC2018

Study objectives

Primary objective
•To assess the percentage of patients that achieve MRD negative response (by PCR) after the first consolidation phase including blinatumomab

Secondary objectives
• To assess the complete and molecular response rate following induction and after blinatumomab consolidation II by the addition of i.v. blinatumomab to standard prephase, consolidation and intensification therapy
• To evaluate EFS
• To evaluate DFS
• To evaluate OS
• To document safety and toxicity of adding blinatumomab to standard prephase and consolidation therapy in adult ALL (two times)
• To assess clinical outcome of patients receiving maintenance or allogeneic SCT
• To assess kinetics of T-cells and B-cells and their various subsets during treatment and assess their predictive value as regard to molecular response
• To compare the results of molecular and flowcytometric MRD measurements at the same timepoints.

2. Patient eligibility criteria

Inclusion criteria

• Primary CD19 positive precursor B-ALL (excluding mature B-cell ALL and B-lymphoblastic lymphoma, but including Philadelphia positive/BCR-ABL positive ALL and CD19 positive mixed phenotype acute lymphoblastic leukemia (MPAL);
• Patients aged 18 to 70 years inclusive;
• WHO performance status 0-2;
• Negative pregnancy test at inclusion, if applicable;
• Written informed consent;
• Patient is capable of giving informed consent.

Exclusion criteria

• Mature B-cell leukemia/lymphoma, B-lymphoblastic lymphoma, isolated extramedullary disease;
• CML in blast crisis;
• Acute undifferentiated leukemia;
• Previous treatment with chemotherapy for precursor B-ALL (maximum 5 days of steroid treatment is allowed)
• Persistent liver enzyme disorders (ASAT/ALAT) >5xULN despite steroid pre-treatment (see also 8.1.3.)
• Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease);
• Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);
• Severe neurological or psychiatric disease;
• Active, uncontrolled infection;
• Clinically overt central nervous system disease;
• History of active malignancy during the past 5 years with the exception of basal cell carcinoma of the skin or stage 0 cervical carcinoma;
• Patient known to be HIV-positive;
• Pregnant or breast-feeding female patients;
• Unwilling or not capable to use effective means of birth control (all men, all premenopausal women under the age of 50 need contraception for two years after the last period, and women older than 50 years for at least one year);
• Current participation in another clinical trial;
• Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

3. Registration (& randomization) of patients

4. Participating parties

5. Participating sites

6. Instruction videos

7. Download documentation / forms

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