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)
- Conditions
- Patients with Philadelphia chromosome negative (Ph-) high-risk (HR) first relapse B-precursor ALL (as defined by I-BFM SG/IntReALL criteria)MedDRA version: 20.0 Level: LLT Classification code 10063625 Term: Acute lymphoblastic leukemia recurrent System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 20.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10066109 Term: Precursor B-lymphoblastic leukemia acute System Organ Class: 100000004864
- Registration Number
- EUCTR2014-002476-92-PL
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 202
* 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
* 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
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