Historical Data Analysis of Complete Remission in Children With R/R Acute Lymphoblastic Leukemia (ALL)

Amgen

Status: Completed

Conditions: B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

Treatments: Other: Other: not applicable - observational study

Study type: Observational

Funder types: Industry

Identifiers

NCT02303522

20120299

Details and patient eligibility

About

An historical data comparator study for children with relapsed/refactory acute lymphoblastic leukemia (ALL).

Full description

A retrospective observational study reviewing historical complete remission for pediatric patients who had either relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL)

Enrollment: 207 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric (age less than 18 years) patients with relapsed or refractory B-cell precursor ALL, specifically those with
• 2nd or later relapse after chemotherapy (with no prior transplantation),
• Relapse after HSCT, or
• Refractory disease
• Had treatment for relapsed or refractory disease between 2005-2012
• Has data available on ALL treatment, including number of salvage treatments, response status after therapies, and HSCT

Exclusion criteria

• No CNS involvement at relapse
• No previous treatment with blinatumomab

Trial design

207 participants in 1 patient group

All subjects

Description:

All subjects will be included in a unique cohort

Treatment:

Other: Other: not applicable - observational study