Acute Myeloid Leukemia Clinical Trial
— LAM-MMROfficial title:
Ruolo Prognostico Della Malattia Minima Residua Nella Leucemia Mieloide Acuta
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)
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Città della Salute e della Scienza di Torino |
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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