A Randomized, Open-label, Controlled Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)

Amgen Inc0 sites320 target enrollmentMay 22, 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with Philadelphia chromosome negative (Ph-) high-risk (HR) first relapse B-precursor ALL (as defined by I-BFM SG/IntReALL criteria)
Sponsor: Amgen Inc
Enrollment: 320
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

May 22, 2015

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•\* Subjects with Philadelphia (Ph\-) chromosome negative high\-risk (HR) first relapse B\-precursor ALL (as defined by I\-BFM SG/IntReALL criteria)
•\* Subjects with M1 or M2 marrow (\< 25% leukemic cells by cytomorphology) at the time of randomization
•\* Age \> 28 days and \< 18 years at the time of informed consent/assent
•\* 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
•Availability of the following material from relapse diagnosis for central analysis of MRD by PCR: clone\-specific primers and reference DNA, as well as primer sequences and analyzed sequences of clonal rearrangements (cases with isolated extramedullary relapse or cases with technical and/or logistic hurdles to obtain and process bone marrow material are exempt from providing this material. In these cases, central MRD analysis only by Flow is permitted).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 202
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no

•\* Clinically relevant CNS pathology requiring treatment (eg, unstable epilepsy) Evidence of current CNS (CNS 2, CNS 3\) involvement by ALL. Subjects with CNS relapse at the time of relapse are eligible if CNS is successfully treated prior to enrollment.
•\* Abnormal renal or hepatic function prior to start of treatment (day 1\) as defined in the 20120215 protocol
•a. Serum creatinine levels above upper limit of normal, based on the normal ranges for age and gender of the local laboratories
•b. Total bilirubin \> 3\.0 mg/dL (for subjects with total bilirubin \< 1\.5 mg/dL, measurement of direct bilirubin is not required) prior to start of treatment (unless related to Gilbert’s or Meulengracht disease)
•\* Peripheral neutrophils \< 500/µl prior to start of treatment
•\* Peripheral platelets \< 50,000/µl prior to start of treatment
•\* Currently receiving treatment in another investigational device or drug study, or less than 4 weeks since ending treatment on another investigational device or drug study(s). Procedures required by IntReALL HR guidelines are allowed.
•\* Chemotherapy related toxicities that have not resolved to \= grade 2
•\* Symptoms and/or clinical signs and/or radiological and/or sonographic signs that indicate an acute or uncontrolled chronic infection, any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol
•\* Documented infection with HIV