Long-term follow-up of adult patients previously enrolled in Study 00103311 with a type of acute lymphoblastic leukemia that did not respond to previous therapy or that relapsed after initially successful previous therapy

Long-term Follow-up of Adult Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia Relapsed Refractory Patients Enrolled in Study 00103311

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001575-37-DE

Enrollment

108

Registered

2019-12-20

Start date

2020-03-04

Completion date

Unknown

Last updated

2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients with relapsed and/or refractory B-precursor acute lymphoblastic leukaemialastic leukaemia MedDRA version: 21.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864 MedDRA version: 21.0 Level: LLT Classification code 10063625 Term: Acute lymphoblastic leukemia recurrent System Organ Class: 100000004864

Interventions

Trade Name: Blincyto Product Name: Blinatumomab Product Code: AMG 103 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Blinatumomab CAS Number: 853426-35-4 Cu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients that were alive at the last follow-up and still participating in the Phase III Study 00103311. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28

Exclusion criteria

Exclusion criteria: not applicable

Design outcomes

Primary

Measure	Time frame
Main Objective: To update the overall survival (OS) Kaplan-Meier probability estimates and the plot last reported in the randomized Phase 3 blinatumomab 00103311 study.;Secondary Objective: not applicable;Primary end point(s): overall survival;Timepoint(s) of evaluation of this end point: at the event of death or censoring at end of follow-up	—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Australia, Austria, Belgium, Bulgaria, Canada, France, Germany, Greece, Ireland, Israel, Italy, Korea, Republic of, Mexico, Poland, Russian Federation, Spain, Taiwan, Turkey, United Kingdom, United States

Contacts

Public ContactMedical Information

Amgen GmbH

eudemedinf@amgen.com+498002643644

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026