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NCT02003612 Clinical Trial

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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:
An Analysis of Historical Data on Hematological Remission and Survival Among Adult Patients With Relapsed / Refractory B-Precursor Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02003612
Other study ID # 20120310
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2013
Est. completion date April 28, 2014

Study information
Verified date November 2022
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 2373
Est. completion date April 28, 2014
Est. primary completion date January 10, 2014
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Not applicable - observational study
No intervention exists as this is a retrospective observational study

Locations
Country Name City State
Czechia Research Site Brno
France Research Site Paris Cedex 10
Germany Research Site Frankfurt am Main
Italy Research Site Bologna
Italy Research Site Venezia
Poland Research Site Gliwice
Spain Research Site Badalona Cataluña
United Kingdom Research Site London
United States Research Site Boston Massachusetts
United States Research Site Cleveland Ohio

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Czechia,  France,  Germany,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) Approx 1 year
Secondary 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 Approx 1 year
Secondary 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 Approx 1 year
Secondary 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 Approx 1 year
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