Clinical trial · Observational

Prognostic Role of Minimal Residual Disease in Acute Myeloid Leukemia

Ruolo Prognostico Della Malattia Minima Residua Nella Leucemia Mieloide Acuta

NCT02714790CI-TRIAL-00021472LAM-MMRcompletedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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)

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Acute Myeloid Leukemia	Acute Myeloid Leukemia	CURATED_BROADER	0.80
Minimal Residual Disease	—	UNRESOLVED	—
Wilms Tumor	Wilms Tumor	ONTOLOGY_EXACT	0.90

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Response
timeFrame
+28 days after End of induction chemotherapy - Before Allogeneic Transplant, average of 3 to 6 months from beginning of therapy
description
Complete remission after chemotherapy

Secondary outcomes (3)

measure
Disease Free Survival
timeFrame
+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)
description
Date of relapse or date of remission status
measure
Overall Survival
timeFrame
Date of last follow-up for at least 1 year (up to 10 years) or Death
description
Time to last follow-up or death

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 19 Years

Show eligibility criteria text

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

References

Publications (1)

DERIVEDFrairia 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 28846953