EUCTR2014-002476-92-PLActive, not recruitingPhase 1
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)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Amgen Inc
- Enrollment
- 202
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
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
- •* 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
- •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. Total bilirubin > 3.0 mg/dl 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). 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
- •* Documented infection with HIV
- •* Known hypersensitivity to immunoglobulins or any of the products or
- •components to be administered during dosing (excluding asparaginase)
- •* Post-menarchal female subject who is pregnant or breastfeeding, or is
- •planning to become pregnant or breastfeed while receiving protocolspecified
- •therapy and for at least 6 months after the last dose of
- •blinatumomab, or 12 months after the last dose of chemotherapy
- •* Post-menarchal female subject who is not willing to practice true
- •sexual abstinence or use a highly effective form of contraception while
- •receiving protocol-specified therapy and for at least 6 months after the
- •last dose of blinatumomab, or 12 months after the last dose of
- •chemotherapy
- •* Sexually mature male subject who is not willing to practice true sexual
- •abstinence or use a condom with spermicide while receiving protocolspecified
- •therapy and for at least 6 months thereafter. In countries
- •where spermicide is not available, a condom without spermicide is
- •acceptable.
- •* Sexually mature male subject who is not willing to abstain from sperm
- •donation while receiving protocol-specified 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
Investigators
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