Study Complete
Sponsor ID
20150253

An study of patients with Ph- chromosome-negative relapsed or refractory acute lymphoblastic leukemia in the US

Sponsor ID
20150253
Clinicaltrials.gov ID
NCT02783651
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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

Additional Study Details

Phase
Phase 4
Product
blinatumomab
Type
Observational
Masking
N/A
Enrollment
212
Additional Study Details

Protocol Summary

Primary Outcome Measures

Treatment patterns in patients with Ph- R/R ALL

Timeframe: 86 months

Drug utilization in patients with Ph- R/R ALL

Timeframe: 86 months

Healthcare resource utilization in patients with Ph- R/R ALL

Timeframe: 86 months

Secondary Outcome Measures

Receipt of allogeneic stem cell transplantation following salvage treatment

Timeframe: 86 Months

Incidence of selected adverse events including cytokine release syndrome, neurologic events, any events resulting in hospitalizations, and other serious adverse events.

Timeframe: 86 Months

Best response to salvage treatment (chemotherapy or blinatumomab) within 8 weeks and within 12 weeks of initiation of salvage treatment.

Timeframe: 12 Weeks

MRD status within 12 weeks of initiation of salvage treatment

Timeframe: 12 Weeks

Overall survival from the time of initiation of salvage treatment

Timeframe: 86 Months

RFS from time remission achieved with salvage treatment

Timeframe: 86 Months

Locations

Location
Status
Contact Us
Location
Research Site
Baltimore, MD, United States, 21201
Status
Recruiting
Location
Research Site
Ames, IA, United States, 50010
Status
Recruiting
Location
Research Site
Detroit, MI, United States, 48201
Status
Recruiting
Location
Research Site
Philadelphia, PA, United States, 19107
Status
Recruiting
Location
Research Site
Duarte, CA, United States, 91010
Status
Recruiting
Location
Research Site
Chicago, IL, United States, 60612
Status
Completed
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