An Open-Label, Multi-center, Expanded Access Protocol of Blinatumomab for the Treatment of Pediatric and Adolescent Subjects with Relapsed and/or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (Rialto Study) - Rialto Study

Amgen Inc.0 sites110 target enrollmentJanuary 7, 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Pediatric and Adolescent Subjects with Relapsed and/or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
Sponsor: Amgen Inc.
Enrollment: 110
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

January 7, 2015

End Date

January 10, 2020

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Morphologic and immunophenotypic evidence of CD19 positive B\-precursor ALL (pro B\-, pre B\-, common ALL) with \= 5% blasts in bone marrow (M2 and M3\) at study enrollment
•2\. Age \> 28 days and \< 18 years at the time of informed consent/assent
•3\. Relapsed/refractory disease, defined as one of the following:
•Second or later bone marrow relapse;
•Any marrow relapse after alloHSCT; or
•Refractory to other treatments:
•o For patients in first relapse: failure to achieve a CR following a full standard reinduction chemotherapy regimen
•o For patients who have not achieved a first remission: failure to achieve remission following a full standard induction regimen
•Subjects previously treated with blinatumomab may be eligible, if subject ended treatment for reason(s) other than disease progression or intolerability to blinatumomab
•4\. Subject’s legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study\-specific activities/ procedures being initiated

•1\. Any active acute Graft\-versus\-Host Disease (GvHD) grade 2 to grade 4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment
•2\. Immunosuppressive agents to prevent or treat GvHD within 2 weeks prior to blinatumomab treatment (except for topical corticosteroids)
•3\. Active (overt) ALL in the CNS (confirmed by cerebrospinal fluid \[CSF] analysis) or in testes
•4\. History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis
•\- With the exception of CNS leukemia that is well controlled with intrathecal therapy
•5\. Current autoimmune disease or history of autoimmune disease with potential CNS involvement
•6\. Cancer chemotherapy within 2 weeks prior to start of blinatumomab (except for tyrosine kinase inhibitors (TKI) and/or low dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, glucocorticoids; intrathecal chemotherapy and dexamethasone are allowed until start of blinatumomab).
•7\. Chemotherapy related toxicities that haven’t resolved to \= grade 2
•8\. Radiotherapy within 2 weeks prior to blinatumomab treatment
•9\. Immunotherapy (eg, rituximab) within 4 weeks prior to blinatumomab treatment