Clinical Study to Investigate the Efficacy, Safety, and Tolerability of the bispecific antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse Acute Lymphoblastic Leukemia (ALL)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 320

Inclusion Criteria

* 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 320
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
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

* 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. Direct bilirubin > 1.5 mg/dl prior to start of treatment (unless related to Gilbert?s or Meulengracht disease)
* Peripheral neutrophils < 500/?l prior to start of treatment
* Peripheral platelets < 50,000/?l 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). Other investigational procedures while participating in this study are excluded. 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
* Known infection with HIV
* Known hypersensitivity to immunoglobulins or any of the products or components to be administered during dosing
* Post-menarchal subject who is pregnant or breastfeeding, or is planning to become pregnant or breastfeed while receiving protocol-required therapy and for at least 12 months thereafter
* Post-menarchal female subject who is not willing to practice true abstinence or use a highly effective form of contraception while receiving protocol-required therapy and for at least 12 months thereafter
* Sexually mature male subject who is not willing to practice true abstinence or use a condom while receiving protocol-required therapy and for at least 6 months thereafter
* Sexually mature male subject who is not willing to abstain from sperm donation while receiving protocol-required therapy and for at least 6 months thereafter
* Subject likely to not be available to complete all protocol-required study visits or procedures, including follow-up visits, and/or to comply with all required study procedures to the best of the subject?s and investigator?s knowledge
* History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
* Placed into an institution due to juridical or regulatory ruling

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

Related Trials