Blinatumomab added to prephase and consolidation therapy in precursor B-acute lymphoblastic leukemia in adults.A phase II trial.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 71

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

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;
-Patients with a currently active second malignancy. Patients are not
considered to have a currently active malignancy if they have completed
therapy and are considered by their physician to be at < 30% risk of
relapse within one year. However, patients with the following
history/concurrent conditions are allowed:
o Basal or squamous cell carcinoma of the skin
o Carcinoma in situ of the cervix
o Carcinoma in situ of the breast
o Incidental histologic finding of prostate 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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