Prognostic Role of Minimal Residual Disease in Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

— LAM-MMR  

Official title:

Ruolo Prognostico Della Malattia Minima Residua Nella Leucemia Mieloide Acuta

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714790
• Other study ID #: LAM-MMR
• Status: Completed
• Phase: N/A
• First received: March 3, 2016
• Last updated: March 22, 2016
• Start date: May 2015
• Est. completion date: June 2015

Study information

• Verified date: March 2016
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Minimal Residual Disease
• Neoplasm, Residual
• Wilms Tumor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response	Complete remission after chemotherapy	+28 days after End of induction chemotherapy - Before Allogeneic Transplant, average of 3 to 6 months from beginning of therapy	No
Secondary	Disease Free Survival	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)	No
Secondary	Overall Survival	Time to last follow-up or death	Date of last follow-up for at least 1 year (up to 10 years) or Death	No
Secondary	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.	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	No