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Prognostic Role of Minimal Residual Disease in Acute Myeloid Leukemia (LAM-MMR)

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ClinicalTrials.gov Identifier: NCT02714790
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Ernesta Audisio, Azienda Ospedaliera Città della Salute e della Scienza di Torino

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)

Condition or disease
Acute Myeloid Leukemia Minimal Residual Disease Wilms Tumor

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Study Type : Observational
Actual Enrollment : 281 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Ruolo Prognostico Della Malattia Minima Residua Nella Leucemia Mieloide Acuta
Study Start Date : May 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patient with new diagnosis of acute myeloid leukemia treated with intensive chemotherapy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714790


Sponsors and Collaborators
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Investigators
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Principal Investigator: Ernesta Audisio, MD AO Città della Salute e della Scienza di Torino
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ernesta Audisio, MD, Azienda Ospedaliera Città della Salute e della Scienza di Torino
ClinicalTrials.gov Identifier: NCT02714790    
Other Study ID Numbers: LAM-MMR
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: paper publication
Keywords provided by Ernesta Audisio, Azienda Ospedaliera Città della Salute e della Scienza di Torino:
Acute Myeloid Leukemia
Minimal Residual Disease
Wilms Tumor
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasm, Residual
Wilms Tumor
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms, Complex and Mixed
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Kidney Diseases
Urologic Diseases
Genetic Diseases, Inborn