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 leukaemia; MedDRA version: 21.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864; MedDRA version: 21.0Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001575-37-DE
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-20
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 108

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

not applicable

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified