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 - NA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001575-37-IT

Enrollment

108

Registered

2021-05-25

Start date

2019-11-28

Completion date

Unknown

Last updated

2021-07-21

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

Product Name: Blinatumomab Product Code: [AMG 103] Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: BLINATUMOMAB CAS Number: 853426-35-4 Current Sponsor code: AMG 103 Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who were enrolled originally in the 00103311 trial (A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study)). 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: NA

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: NA;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	—

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 S.r.l.

medicalinformationitaly@amgen.com0039026241121

Outcome results

None listed

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