Clinical trial NCT02783651: An Study of Patients With Ph- Chromosome-negative Relapsed or Refractory Acute Lymphoblastic Leukemia in the US
Official title: An Observational Study of Patients With Philadelphia Chromosome-negative Relapsed or Refractory Acute Lymphoblastic Leukemia in the US
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsed/Refractory Acute Lymphoblastic Leukemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-05-26
Enrollment: 212
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients initiating treatment for Philadelphia chromosome-negative (Ph-) R/R ALL between January 2013 and March 2019 at participating clinical sites in the US

Brief summary: A retrospective chart review study of Philadelphia chromosome-negative R/R ALL patients in the US.


Eligibility criteria: Inclusion Criteria

-Medical records of patients initiating treatment for Ph- R/R ALL at participating clinical centers in the US between January 2013 and March 2019 will be eligible for inclusion.

Exclusion Criteria

* Medical records of patients with Ph+ ALL will be excluded.
* If informed consent is required, medical records of patients who do not provide informed consent will be excluded.

Primary outcomes:
measure: Treatment patterns in patients with Ph- R/R ALL
timeFrame: 86 months
measure: Drug utilization in patients with Ph- R/R ALL
timeFrame: 86 months
measure: Healthcare resource utilization in patients with Ph- R/R ALL
timeFrame: 86 months
Secondary outcomes:
measure: Receipt of allogeneic stem cell transplantation following salvage treatment
timeFrame: 86 Months
measure: Incidence of selected adverse events including cytokine release syndrome, neurologic events, any events resulting in hospitalizations, and other serious adverse events.
timeFrame: 86 Months
measure: Best response to salvage treatment (chemotherapy or blinatumomab) within 8 weeks and within 12 weeks of initiation of salvage treatment.
timeFrame: 12 Weeks
measure: MRD status within 12 weeks of initiation of salvage treatment
timeFrame: 12 Weeks
measure: Overall survival from the time of initiation of salvage treatment
timeFrame: 86 Months
measure: RFS from time remission achieved with salvage treatment
timeFrame: 86 Months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Duarte
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Ames
country: United States
facility: Research Site
state: Iowa
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Hackensack
country: United States
facility: Research Site
state: New Jersey
city: Buffalo
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Austin
country: United States
facility: Research Site
state: Texas
city: Seattle
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: