An Study of Patients With Ph- Chromosome-negative Relapsed or Refractory Acute Lymphoblastic Leukemia in the US
Completed
- Conditions
- Relapsed/Refractory Acute Lymphoblastic Leukemia
- Interventions
- Other: Other
- Registration Number
- NCT02783651
- Lead Sponsor
- Amgen
- Brief Summary
A retrospective chart review study of Philadelphia chromosome-negative R/R ALL patients in the US.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 212
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description No Treatment 2 Other Initial record abstraction will occur at study site with subsequent reviews occurring at the site every 3 months thereafter until study conclusion on March 2020. No treatment 1 Other It is planned to have 20-30 sites participating on the trial for chart review of approximately 200-235 patients initiating treatment for Philadelphia chromosome-negative (Ph-) Relapsed or Refractory (R/R) Acute Lymphoblastic Leukemia (ALL) between January 2013 and March 2019.
- Primary Outcome Measures
Name Time Method Drug utilization in patients with Ph- R/R ALL 86 months Treatment patterns in patients with Ph- R/R ALL 86 months Healthcare resource utilization in patients with Ph- R/R ALL 86 months
- Secondary Outcome Measures
Name Time Method Incidence of selected adverse events including cytokine release syndrome, neurologic events, any events resulting in hospitalizations, and other serious adverse events. 86 Months RFS from time remission achieved with salvage treatment 86 Months MRD status within 12 weeks of initiation of salvage treatment 12 Weeks Overall survival from the time of initiation of salvage treatment 86 Months Receipt of allogeneic stem cell transplantation following salvage treatment 86 Months Best response to salvage treatment (chemotherapy or blinatumomab) within 8 weeks and within 12 weeks of initiation of salvage treatment. 12 Weeks
Trial Locations
- Locations (1)
Research Site
🇺🇸Seattle, Washington, United States