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Clinical picture: ALL (Acute Lymphatic Leukemia)

Trial: HOVON 146 B-ALL


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


HO146 News

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 hieronder terugvinden bij 7.Download documentation.

 

Alvorens uw centrum geactiveerd kan worden voor de studie verzoeken wij u:

Ø Onderstaande documenten (die ook vermeld staan in het bijgevoegde site document checklist) naar het HDC te sturen:

- ‘’natte’’ Signed protocol signature page (per post t.a.v J.Refos)

- Site specific PIF – Word format (graag alleen de site specifieke contact informatie aanpassen) (via mail naar

j.refos@erasmusmc.nl)

- Signed signature log (via mail naar j.refos@erasmusmc.nl)

- Completed local contact form (via mail naar j.refos@erasmusmc.nl)

- Lab accreditation and reference values (indien van toepassing) (via mail naar j.refos@erasmusmc.nl)

Ø Een site agreement te tekenen (waarvoor uw ziekenhuis is benaderd door het HOVON bureau).

Ø Een ALEA account aan te maken; Let op: vanwege databasae technische redenen dient de local investigator altijd een account te hebben.

 

Wanneer alle documenten compleet zijn, zal het HDC de eerste medicatie bestelling doen en na ontvangst van de medicatie uw ziekenhuis activeren voor inclusie. U ontvangt een e-mail om u hierover te informeren.

 

Namens de PI , dr. Anita Rijneveld, wensen wij u veel succes met de lokale voorbereidingen en hopen samen met u de studie succesvol te kunnen volbrengen.

Voor vragen of opmerkingen kunt u contact opnemen met het Hovon data center.


1. Overview



Status

open



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

80


Approved by

NL: METC 9MAR2018
NL: CCMO 14DEC2017


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



Site
Included patients *
NL-Rotterdam-Erasmus MC - Centrum
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

 Patient Information & IC form (NL)



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