Clinical trial · Observational

Acute Myeloid Leukemia Real World Treatment Patterns

Characteristics, Treatment Patterns, and Clinical Outcomes in Non-intensive Chemotherapy Acute Myeloid Leukemia (AML) Patients - a US Real-World Study Using Electronic Medical Record Data

NCT04230564CI-TRIAL-00066959withdrawnClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Study was cancelled prior to any enrollment

Summary

Brief summary (as posted)

Among patients with a diagnosis of AML who received non-intensive chemotherapy: * Describe patient demographic and clinical characteristics * Describe treatment patterns * Describe effectiveness outcomes * Evaluate tumor response

Conditions

Conditions (1)

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

Condition (as posted)	Mapped entity	Match	Confidence
Leukemia, Myeloid, Acute	Leukemia	ONTOLOGY_EXACT	0.85

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
azacitidine	Drug	Azacitidine	ALIAS
glasdegib	Drug	Glasdegib	ALIAS
venetoclax	Drug	Venetoclax	ALIAS

Design

Arms and outcomes

Arms (1)

label
AML
description
Patients diagnosed with AML
interventionNames
1. Drug: azacitidine
2. Drug: venetoclax
3. Drug: glasdegib

Primary outcomes (6)

measure
Overall Survival
timeFrame
January 1, 2012 to January 10, 2020
description
Overall survival was the duration from diagnosis of disease to death.
measure
Event Free Survival
timeFrame
January 1, 2012 to January 10, 2020
description
Time from the treatment initiation date to the date of treatment failure (TF), relapse from CR or better, or death from any cause, whichever comes first

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Confirmed diagnosis of AML on or after 01 January 2012 through Clinical Research Nurse (CRN) review of provider documentation of AML diagnosis in the medical record.
2. Receipt of non-intensive therapy at any point during first line therapy following initial AML diagnosis. For this study, non-intensive therapy will be defined as 1 of the following agents, alone or in combination with any other agent:

   1. AZA
   2. GLAS
   3. VEN
3. Age ≥18 years at initial diagnosis of AML.

Exclusion Criteria:

Patients meeting any of the following criteria will not be included in the study:

1\. Record of 1 or more of the following confounding diagnoses at any point before or after AML diagnosis: Acute lymphoblastic leukemia; acute promyelocytic leukemia, aggressive systemic mastocytosis; hypereosinophilic syndrome and/or chronic eosinophilic leukemia; dermatofibrosarcoma protuberans; gastrointestinal stromal tumors.

References

Publications (0)

Data not yet available

No reference posted for this study.