Prognostic Role of Minimal Residual Disease in Acute Myeloid Leukemia

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)

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Key information

Conditions

Acute Myeloid Leukemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Kidney Neoplasms Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Male Urogenital Diseases Minimal Residual Disease Neoplasm, Residual Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplastic Processes Neoplastic Syndromes, Hereditary Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Wilms Tumor

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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)

Date of relapse or date of remission status
Overall Survival

Time frame: 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

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

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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Ruolo Prognostico Della Malattia Minima Residua Nella Leucemia Mieloide Acuta

Acronym: LAM-MMR

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Mar 22, 2016
Registry last updated: Mar 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed