Prognostic Role of Minimal Residual Disease in Acute Myeloid Leukemia (LAM-MMR)

March 22, 2016 updated by: Ernesta Audisio, Azienda Ospedaliera Città della Salute e della Scienza di Torino

Ruolo Prognostico Della Malattia Minima Residua Nella Leucemia Mieloide Acuta

Study purpose is to assess the prognostic role of Minimal Residual Disease (defined as medullary expression of WT1 gene), performed at Baseline and during treatment according to clinical practice. MRD results will be relate to treatment outcome and survival analysis variables (Overall Survival, Disease Free Survival, Cumulative Incidence of Relapse)

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

281

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patient with new diagnosis of acute myeloid leukemia treated with intensive chemotherapy

Description

Inclusion Criteria:

  • Diagnosis of Acute Myeloid Leukemia
  • Age > 18 years
  • Intensive chemotherapy as first line curative treatment
  • Observation period: March 2004 - September 2014
  • Bone marrow WT1 expression and Immunophenotyping by multi-parametric flow cytometry performed at baseline
  • Written informed consent

Exclusion Criteria:

  • Diagnosis of Acute Promyelocytic Leukemia
  • Bone marrow WT1 expression and Immunophenotyping by multi-parametric flow cytometry NOT performed at baseline
  • Patient ineligible to intensive chemotherapy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response
Time Frame: +28 days after End of induction chemotherapy - Before Allogeneic Transplant, average of 3 to 6 months from beginning of therapy
Complete remission after chemotherapy
+28 days after End of induction chemotherapy - Before Allogeneic Transplant, average of 3 to 6 months from beginning of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival
Time Frame: +28 days after End of induction chemotherapy -Before Allogeneic Transplant, average of 3 to 6 months from beginning of therapy - +30 days after Allogeneic Transplant - Date of Relapse for at least 1 year (up to 10 years)
Date of relapse or date of remission status
+28 days after End of induction chemotherapy -Before Allogeneic Transplant, average of 3 to 6 months from beginning of therapy - +30 days after Allogeneic Transplant - Date of Relapse for at least 1 year (up to 10 years)
Overall Survival
Time Frame: Date of last follow-up for at least 1 year (up to 10 years) or Death
Time to last follow-up or death
Date of last follow-up for at least 1 year (up to 10 years) or Death
Cumulative Incidence of Relapse
Time Frame: Date of Allogeneic Transplant, Date of Relapse for at least 1 year (up to 10 years - assessed every 3 months), Date of last follow-up for at least 1 year (up to 10 years) or Death
CIR was calculated from the date of allo-HCT to the date of relapse or the date of the last follow-up, with death without relapse as a competing event.
Date of Allogeneic Transplant, Date of Relapse for at least 1 year (up to 10 years - assessed every 3 months), Date of last follow-up for at least 1 year (up to 10 years) or Death

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Investigators

  • Principal Investigator: Ernesta Audisio, MD, AO Città della Salute e della Scienza di Torino

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

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

May 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (Estimate)

March 22, 2016

Study Record Updates

Last Update Posted (Estimate)

March 23, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAM-MMR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

paper publication

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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