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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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1. Overview



Status

planned



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


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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