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

May 4, 2020 updated by: Amgen

A Retrospective Pooled Analysis of Complete Remission Among Pediatric Patients With Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 (Anticipated)

207

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

  • Austria
      • Wien, Austria, 1090
        • Research Site
  • Germany
      • Berlin, Germany, 13353
        • Research Site
  • Italy
      • Roma, Italy, 00165
        • 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

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All subjects
All subjects will be included in a unique cohort
Other: 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 (CR)
Time Frame: Approx. 1 year
To estimate hematological Complete Remission (CR) in pediatric patients with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL)
Approx. 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Approx. 1 year
OS following salvage therapy: defined as time to death.
Approx. 1 year
Molecular CR
Time Frame: Approx. 1 year
Defined as MRD <10-4 measured either by PCR or flow cytometry.
Approx. 1 year
Relapse Free Survival (RFS)
Time Frame: Approx. 1 year
Defined as time to relapse or death.
Approx. 1 year
Time to hematological CR
Time Frame: Approx. 1 year
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
Approx. 1 year
Receipt of HSCT after salvage treatment
Time Frame: Approx. 1 year
Defined as the receipt of HSCT after chemotherapy or a previously failed HSCT.
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.

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)

December 9, 2014

Primary Completion (Actual)

January 22, 2015

Study Completion (Actual)

January 22, 2015

Study Registration Dates

First Submitted

November 6, 2014

First Submitted That Met QC Criteria

November 28, 2014

First Posted (Estimate)

December 1, 2014

Study Record Updates

Last Update Posted (Actual)

May 6, 2020

Last Update Submitted That Met QC Criteria

May 4, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120299

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.

Clinical Trials on B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

Clinical Trials on Other: not applicable - observational study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe