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

Amgen207 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

207

Conditions

B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

Interventions

Other: not applicable - observational studyOTHER

No intervention exists as this is a retrospective observational study

Eligibility

Sex: ALLMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (3)

Research Site

Vienna, Austria

Research Site

Berlin, Germany

Research Site

Roma, Italy

Outcomes

Primary Outcomes

Hematological Complete Remission (CR)

To estimate hematological Complete Remission (CR) in pediatric patients with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL)

Time frame: Approx. 1 year

Secondary Outcomes

Overall survival

OS following salvage therapy: defined as time to death.

Time frame: Approx. 1 year

Molecular CR

Defined as MRD \<10-4 measured either by PCR or flow cytometry.

Time frame: Approx. 1 year

Relapse Free Survival (RFS)

Defined as time to relapse or death.

Time frame: Approx. 1 year

Time to hematological CR

Defined as time to unequivocal detection of \>5% leukemia cells in bone marrow as measured by cytological, microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia

Time frame: Approx. 1 year

Receipt of HSCT after salvage treatment

Defined as the receipt of HSCT after chemotherapy or a previously failed HSCT.

Time frame: Approx. 1 year

Data from ClinicalTrials.gov

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