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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02714790
Other study ID # LAM-MMR
Secondary ID
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


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
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