ong-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
Phase 1
- Conditions
- Adult patients with relapsed and/or refractory B-precursor acute lymphoblastic leukaemialastic leukaemiaMedDRA version: 21.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-001575-37-IT
- Lead Sponsor
- AMGEN INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
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
NA
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method