Ruolo Prognostico Della Malattia Minima Residua Nella Leucemia Mieloide Acuta

A.O.U. Città della Salute e della Scienza0 sites281 target enrollmentMay 2015

ConditionsAcute Myeloid Leukemia Minimal Residual Disease Wilms Tumor

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Myeloid Leukemia
Sponsor: A.O.U. Città della Salute e della Scienza
Enrollment: 281
Primary Endpoint: Response
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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)

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

June 2015

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

A.O.U. Città della Salute e della Scienza

Responsible Party

Principal Investigator

Ernesta Audisio

A.O.U. Città della Salute e della Scienza

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

Disease Free Survival(+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(Date of last follow-up for at least 1 year (up to 10 years) or Death)
Cumulative Incidence of Relapse(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)