The effect of blinatumomab administered before high-dose chemotherapy in treatment of acute lymphoblastic leukemia in adults.

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]; ewly diagnosed, previously untreated, Ph-negative B-precursor acute lymphoblastic leukemia; MedDRA version: 20.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864

• Registration Number: EUCTR2017-004577-14-CZ
• Lead Sponsor: Ústav hematologie a krevní transfuze

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

-Patients with newly diagnosed, previously untreated, Ph-negative B-precursor acute lymphoblastic leukemia;
-Age 18-65 years;
-Lymphoblasts positive for CD19;
-Eligible to intensive chemotherapy, due to general health status;
-ECOG performance status =2;
-Diagnostic sample of bone marrow (or peripheral blood with >50% of blasts) available for central MRD assessment;
-Subject has provided written informed consent prior to any screening procedure.
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

-History of malignancy other than ALL within 5 years prior to start of protocol-required therapy, except for adequately treated selected cancers without evidence of disease;
-History or presence of central nervous system (CNS) pathology as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis;
-Persisting ALL in the CNS at the end of run-in period; patients with initial cerebrospinal fluid (CSF) infiltration arriving into CSF negativity after up to 4 intrathecal applications of chemotherapy within the first 10 days of therapy are allowed for the study;
-Current autoimmune disease or history of autoimmune disease with potential CNS involvement;
-Active known HBV or HCV hepatitis or positive HIV serology;
-Hypersensitivity to any active substance contained in blinatumomab, including polysorbate 80;
-Vaccination with a live virus vaccine within 4 weeks prior to the study enrolment;
-Female patients who are pregnant or breast feeding or patients of childbearing potential not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug;
-Male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a double barrier method of contraception, one of which includes a condom, during the study;
-Any concurrent severe and/or uncontrolled medical condition, which could, in the opinion of the investigator, compromise participation in the study;
-Concurrent participation in another clinical study with an investigational medical product.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified