Prognostic Role of Minimal Residual Disease in Acute Myeloid Leukemia

Completed

• Conditions: Acute Myeloid Leukemia; Minimal Residual Disease; Wilms Tumor

• Registration Number: NCT02714790
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-03
• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-22
• Last Update Submitted: 2016-03-22
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response	+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 Outcome Measures

Name	Time	Method
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)	Date of relapse or date of remission status
Overall Survival	Date of last follow-up for at least 1 year (up to 10 years) or Death	Time to last follow-up 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	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.