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

November 4, 2022 updated by: Amgen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2373

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 625 00
        • Research Site
  • France
      • Paris Cedex 10, France, 75475
        • Research Site
  • Germany
      • Frankfurt am Main, Germany, 60590
        • Research Site
  • Italy
      • Bologna, Italy, 40138
        • Research Site
      • Venezia, Italy, 30174
        • Research Site
  • Poland
      • Gliwice, Poland, 44-101
        • Research Site
  • Spain
    • Cataluña
      • Badalona, Cataluña, Spain, 08916
        • Research Site
  • United Kingdom
      • London, United Kingdom, NW3 2PF
        • Research Site
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with relapsed / refractory B-precursor acute lymphoblastic leukemia identified in study group databases from multiple sites in EU and US

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All subjects
Other: Not applicable - observational study
No intervention exists as this is a retrospective observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hematological complete remission
Time Frame: 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)
Approx 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 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
Approx 1 year
duration of complete remission
Time Frame: 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
Approx 1 year
proportion of patients receiving allogeneic hematological stem cell transplantation
Time Frame: 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
Approx 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

January 10, 2014

Study Completion (Actual)

April 28, 2014

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

December 2, 2013

First Posted (Estimate)

December 6, 2013

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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