NCT02714790

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)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
281

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

1 month

First QC Date

March 3, 2016

Last Update Submit

March 22, 2016

Conditions

Acute Myeloid LeukemiaMinimal Residual DiseaseWilms Tumor

Keywords

Acute Myeloid LeukemiaMinimal Residual DiseaseWilms Tumor

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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)

  • Overall Survival

    Date of last follow-up for at least 1 year (up to 10 years) 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

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient with new diagnosis of acute myeloid leukemia treated with intensive chemotherapy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Frairia C, Aydin S, Audisio E, Riera L, Aliberti S, Allione B, Busca A, D'Ardia S, Dellacasa CM, Demurtas A, Evangelista A, Ciccone G, Francia di Celle P, Nicolino B, Stacchini A, Marmont F, Vitolo U. Post-remissional and pre-transplant role of minimal residual disease detected by WT1 in acute myeloid leukemia: A retrospective cohort study. Leuk Res. 2017 Oct;61:10-17. doi: 10.1016/j.leukres.2017.08.008. Epub 2017 Aug 30.

    PMID: 28846953DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteNeoplasm, ResidualWilms Tumor

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Complex and MixedKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ernesta Audisio, MD

    AO Città della Salute e della Scienza di Torino

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 22, 2016

Study Start

May 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 23, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

paper publication