Newly 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
Conditions
Interventions
Trade Name: BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
Product Name: BLINCYTO
Product Code: AMG103
Pharmace
Sponsors
Ústav hematologie a krevní transfuze
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the percentage of complete molecular responses after two cycles of induction therapy composed of a single cycle of blinatumomab followed by chemotherapy.;Timepoint(s) of evaluation of this end point: After two cycles of induction therapy, at Week 11.; Secondary Objective: To evaluate minimal residual disease (MRD) in bone marrow at the end of blinatumomab infusion (Induction cycle I); To evaluate progression-free survival (PFS) in patients treated with blinatumomab followed by chemotherapy in the induction therapy; To evaluate overall survival (OS) in patients treated with blinatumomab followed by chemotherapy in the induction therapy; To determine the percentage of patients undergoing allogeneic stem cell transplantation (alloSCT) due to the suboptimal molecular response after blinatumomab and chemotherapy; To evaluate the incidence of infectious complications during induction chemotherapy in patients treated with blinatumomab and chemotherapy; To evaluate the incidence and severity of blinatumomab-related adverse events in the induction therapy. ; Primary end point(s): Efficacy: Defined as a proportion of patients reaching the complete molecular response after two cycles of induction therapy. Molecular response will be monitored by a patient-specific Ig/TCR rearrangements in an assay with the sensitivity of at least 10e-04. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: All AEs will be collected and assessed using the NCI Common Terminology Criteria for Adverse Events, version 4.03. ;Timepoint(s) of evaluation of this end point: At 24 months (cumulatively) | — |
Countries
Czech Republic
Contacts
Public ContactDr. Cyril Šálek
Ústav hematologie a krevní transfuze
Outcome results
None listed