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Clinical Trials/EUCTR2014-002476-92-PL
EUCTR2014-002476-92-PL
Active, not recruiting
Phase 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)

Amgen Inc0 sites202 target enrollmentJune 11, 2015
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ConditionsPatients 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 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10063625 Term: Acute lymphoblastic leukemia recurrent System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10066109 Term: Precursor B-lymphoblastic leukemia acute System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsBlincyto

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
202
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 11, 2015
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Amgen Inc

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

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)

Outcomes

Primary Outcomes

Not specified

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