An observational study of patients with Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia in the US
For patients with relapsed or refractory (R/R) acute lymphoblastic leukemia (ALL), treatment options have been limited and prognosis unfavorable. With the recent approval of BLINCYTO® (blinatumomab) in the US, it is important to understand its “real-world” utilization and to assess and understand its effectiveness and safety when administered in clinical practice. This
observational study will be conducted using medical record review at multiple clinical sites in the US and aims to provide data on the real-world treatment and outcomes of patients with Philadelphia chromosome-negative (Ph-) R/R ALL, including the utilization of healthcare resources, and use, effectiveness, and safety of blinatumomab.
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Ages Eligible for Study: 18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample
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 disease category: Cancer
Sponsor: Amgen
Projected enrollment dates: May 2017 to December 2017
Official study title: An observational study of patients with Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia in the US
ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/NCT02783651