An observational study in Relapsed/Refractory Acute Lymphoblastic Leukemia, sponsored by Amgen. Completed at 19 sites in United States. Per ClinicalTrials.gov, last updated 2020-04-27.
Sponsored by Amgen · Observational
A retrospective chart review study of Philadelphia chromosome-negative R/R ALL patients in the US.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 212 is above the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients initiating treatment for Philadelphia chromosome-negative (Ph-) R/R ALL between January 2013 and March 2019 at participating clinical sites in the US
-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
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.
Other: 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.
Other: Other
No intervention other than routine medical care
Treatment patterns in patients with Ph- R/R ALL
Time frame: 86 months
Drug utilization in patients with Ph- R/R ALL
Time frame: 86 months
Healthcare resource utilization in patients with Ph- R/R ALL
Time frame: 86 months
Receipt of allogeneic stem cell transplantation following salvage treatment
Time frame: 86 Months
Incidence of selected adverse events including cytokine release syndrome, neurologic events, any events resulting in hospitalizations, and other serious adverse events.
Time frame: 86 Months
Best response to salvage treatment (chemotherapy or blinatumomab) within 8 weeks and within 12 weeks of initiation of salvage treatment.
Time frame: 12 Weeks
MRD status within 12 weeks of initiation of salvage treatment
Time frame: 12 Weeks
Overall survival from the time of initiation of salvage treatment
Time frame: 86 Months
RFS from time remission achieved with salvage treatment
Time frame: 86 Months
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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