Historical Data Analysis of Hematological Remission and Survival in Adults With R/R Acute Lymphoblastic Leukemia

Completed

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Other: Not applicable - observational study

• Registration Number: NCT02003612
• Lead Sponsor: Amgen

Brief Summary

A retrospective analysis of historical data looking at hematological remission and survival in adult relapsed / refractory B-precursor acute lymphoblastic leukemia patients.

Detailed Description

A retrospective observational study reviewing historical survival data (hematological remission and survival) for adult patients who have either relapsed or refractory B-precursor acute lymphoblastic leukemia. Data are aggregated across multiple countries and study sites in the EU and US

Study Timeline

• Study Start: 2013-10-01
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Primary Completion: 2014-01-10
• Study Completion: 2014-04-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2373

Inclusion Criteria

• adult patients with relapsed / refractory B-precursor acute lymphoblastic leukemia
• age 15 or older at time of de novo (initial) diagnosis of acute lymphoblastic leukemia
• initial diagnosis of acute lymphoblastic leukemia in the year 1990 or later
• No CNS involvement at relapse
• No isolated extramedullary relapse
• Other inclusion criteria may apply

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All subjects	Not applicable - observational study	All subjects

Primary Outcome Measures

Name	Time	Method
hematological complete remission	Approx 1 year	To estimate the proportion of patients in hematological complete remission (CR) for R/R Philadelphia chromosome negative (Ph-) B-precursor ALL patients following relapse or salvage treatment, excluding patients with a first remission duration of \>12 months in first salvage (ie, patients with late relapse in first salvage)

Secondary Outcome Measures

Name	Time	Method
proportion of patients receiving allogeneic hematological stem cell transplantation	Approx 1 year	estimate the proportion of patients receiving allogeneic hematological stem cell transplantation for philadelphia negative patients following treatment for relapsed / refractory B-precursor acute lymphoblastic leukemia excluding those with late relapse in first salvage
overall survival	Approx 1 year	to estimate overall survival for relapsed / refractory philadelphia negative B-precursor acute lymphoblastic leukemia patients following salvage treatment, excluding patients with late relapse in first salvage
duration of complete remission	Approx 1 year	to estimate the duration of complete remission for philadelphia negative patients following treatment for relapsed / refractory B-precursor acute lymphoblastic leukemia, excluding patients with late relapse in first salvage

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom