Prognostic Role of Minimal Residual Disease in Acute Myeloid Leukemia

Ruolo Prognostico Della Malattia Minima Residua Nella Leucemia Mieloide Acuta

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02714790

Acronym

LAM-MMR

Enrollment

281

Registered

2016-03-22

Start date

2015-05-31

Completion date

2015-06-30

Last updated

2016-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Minimal Residual Disease, Wilms Tumor

Keywords

Acute Myeloid Leukemia, Minimal Residual Disease, Wilms Tumor

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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results