Prognostic Role of Minimal Residual Disease in Acute Myeloid Leukemia

A.O.U. Città della Salute e della Scienza281 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

281

Conditions

Acute Myeloid Leukemia Minimal Residual Disease Wilms Tumor

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Complete remission after chemotherapy

Time frame: +28 days after End of induction chemotherapy - Before Allogeneic Transplant, average of 3 to 6 months from beginning of therapy

Secondary Outcomes

Disease Free Survival

Date of relapse or date of remission status

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)

Overall Survival

Time to last follow-up or death

Time frame: Date of last follow-up for at least 1 year (up to 10 years) or Death

Cumulative Incidence of Relapse

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.

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

Data from ClinicalTrials.gov

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