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

N/ACompletedNCT02003612

Amgen2,373 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

2,373

Conditions

Acute Lymphoblastic Leukemia

Interventions

Not applicable - observational studyOTHER

No intervention exists as this is a retrospective observational study

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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

Locations (10)

Research Site

Boston, Massachusetts, United States

Research Site

Cleveland, Ohio, United States

Research Site

Brno, Czechia

Research Site

Paris, France

Outcomes

Primary Outcomes

hematological complete remission

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)

Time frame: Approx 1 year

Secondary Outcomes

overall survival

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

Time frame: Approx 1 year

duration of complete remission

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

Time frame: Approx 1 year

proportion of patients receiving allogeneic hematological stem cell transplantation

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

Time frame: Approx 1 year

Data from ClinicalTrials.gov

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