Retrospective Analysis of Survival in Adult MRD Positive Acute Lymphoblastic Leukemia Patients

September 12, 2022 updated by: Amgen

A Retrospective Analysis of Hematological Relapse Free Survival and Overall Survival in Adult Patients With Philadelphia-Negative B-Precursor Acute Lymphoblastic Leukemia in Complete Hematological Remission With Minimal Residual Disease

A retrospective analysis of historical data looking at relapse free survival and overall survival rates in adult philadelphia negative B-pre-cursor acute lymphoblastic leukemia patients.

Study Overview

Status

Completed

Conditions

Detailed Description

A retrospective observational study reviewing historical survival data (relapse free survival and overall survival) for adult patients who have philadelphia negative B-precursor acute lymphoblastic leukemia, and are in complete hematological remission with minimal residual disease.

Study Type

Observational

Enrollment (Actual)

310

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
      • Roma, Italy, 00161
        • Research Site
      • Venezia, Italy, 30174
        • Research Site
  • Poland
      • Gliwice, Poland, 44-101
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation, 125167
        • Research Site
  • Spain
    • Cataluña
      • Badalona, Cataluña, Spain, 08916
        • Research Site
  • United Kingdom
      • London, United Kingdom, NW3 2PF
        • 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

adult acute lymphoblastic leukemia

Description

Inclusion Criteria:

  • patients with Philadelphia-negative B-Precursor Acute Lyphmoblastic Leukemia in complete hematological remission defined as less than 5% blasts in bone marrow after at least 3 intensive chemotherapy blocks (i.e. any standard or investigational regimen according to adult protocols as long as 3 age appropriate chemotherapy blocks were given, this also includes relapse treatment
  • detection of minimal residual disease (molecular failure or molecular relapse) at a level of greater than or equal to 10*(-4) by PCR or greater than or equal to 10*(-3) by flow cytometry at a reference lab
  • Age 15 or greater at time of initial diagnosis with acute lymphoblastic leukemia. For patients aged 15-17 treatment according to adult protocols is required
  • Initial diagnosis in the year 2000 or later
  • History of acute lymphoblastic leukemia treatment (including response to first therapy, number of prior relapses) is available
  • Relapse status and disease follow up after timepoint of minimal residual disease detection is available

Exclusion Criteria:

  • Patients with extramedullary disease at timepoint of minimal residual disease detection
  • Use of Blinatumomab within 18 months of minimal residual disease detection
  • Allogeneic hematopoietic stem cell transplantation prior to minimal residual disease detection at the required level

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
primary
subjects who are 18 years or older, who have minimal residual disease detected by PCR at a level of 1/10-3 or higher, who are free form allogeneic stem cell transplantation until hematological relapse or until 18 months after minimal residual disease detection (whichever comes first)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hematological relapse free survival
Time Frame: Approximately 18 months
to estimate the hematological relapse free survival in patients who are 18 years or older, who have minimal residual disease detected by PCR at a level of 1/10-3 or higher, who are free form allogeneic stem cell transplantation until hematological relapse or until 18 months after minimal residual disease detection (whichever comes first)
Approximately 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hematological relapse free survival
Time Frame: Approximately 18 months
to estimate the hematological relapse free survival in patients who are 15 years or older, who have minimal residual disease regardless of detection method, with or without stem cell transplantation within18 months of minimal residual disease detection
Approximately 18 months
overall survival
Time Frame: Approximately 18 months
to estimate overall survival in the 2 sets of patients described in the primary outcome measure, and the first secondary outcome measure.
Approximately 18 months
mortality rate
Time Frame: 100 days following allogeniec stem cell transplantation
to estimate the mortality rate (proportion) at 100 days following allogeneic stem cell transplantation in patients who received an allogeneic stem cell transplantation within 18 months after minimal residual disease detection
100 days following allogeniec stem cell transplantation

Collaborators and Investigators

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

Sponsor

Amgen

Collaborators

European EWALL study groups

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

September 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 25, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimate)

December 13, 2013

Study Record Updates

Last Update Posted (Actual)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120148

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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