Relapsed/Refractory Acute Lymphoblastic Leukemia
Conditions
Brief summary
A retrospective chart review study of Philadelphia chromosome-negative R/R ALL patients in the US.
Interventions
OTHEROther
No intervention other than routine medical care
Sponsors
Amgen
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment patterns in patients with Ph- R/R ALL | 86 months |
| Drug utilization in patients with Ph- R/R ALL | 86 months |
| Healthcare resource utilization in patients with Ph- R/R ALL | 86 months |
Secondary
| Measure | Time frame |
|---|---|
| MRD status within 12 weeks of initiation of salvage treatment | 12 Weeks |
| Receipt of allogeneic stem cell transplantation following salvage treatment | 86 Months |
| RFS from time remission achieved with salvage treatment | 86 Months |
| Overall survival from the time of initiation of salvage treatment | 86 Months |
| Incidence of selected adverse events including cytokine release syndrome, neurologic events, any events resulting in hospitalizations, and other serious adverse events. | 86 Months |
| Best response to salvage treatment (chemotherapy or blinatumomab) within 8 weeks and within 12 weeks of initiation of salvage treatment. | 12 Weeks |
Countries
United States
Outcome results
None listed