Clinical trial NCT02003612: Historical Data Analysis of Hematological Remission and Survival in Adults With R/R Acute Lymphoblastic Leukemia
Official title: An Analysis of Historical Data on Hematological Remission and Survival Among Adult Patients With Relapsed / Refractory B-Precursor Acute Lymphoblastic Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 2373
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with relapsed / refractory B-precursor acute lymphoblastic leukemia identified in study group databases from multiple sites in EU and US

Brief summary: A retrospective analysis of historical data looking at hematological remission and survival in adult relapsed / refractory B-precursor acute lymphoblastic leukemia patients.

Detailed description: A retrospective observational study reviewing historical survival data (hematological remission and survival) for adult patients who have either relapsed or refractory B-precursor acute lymphoblastic leukemia. Data are aggregated across multiple countries and study sites in the EU and US

Eligibility criteria: Inclusion Criteria:

* adult patients with relapsed / refractory B-precursor acute lymphoblastic leukemia
* age 15 or older at time of de novo (initial) diagnosis of acute lymphoblastic leukemia
* initial diagnosis of acute lymphoblastic leukemia in the year 1990 or later
* No CNS involvement at relapse
* No isolated extramedullary relapse
* Other inclusion criteria may apply

Primary outcomes:
measure: hematological complete remission
timeFrame: Approx 1 year
Secondary outcomes:
measure: overall survival
timeFrame: Approx 1 year
measure: duration of complete remission
timeFrame: Approx 1 year
measure: proportion of patients receiving allogeneic hematological stem cell transplantation
timeFrame: Approx 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Brno
country: Czechia
facility: Research Site
city: Paris Cedex 10
country: France
facility: Research Site
city: Frankfurt am Main
country: Germany
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Venezia
country: Italy
facility: Research Site
city: Gliwice
country: Poland
facility: Research Site
city: Badalona
country: Spain
facility: Research Site
state: Cataluña
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Barlev A, Lin VW, Katz A, Hu K, Cong Z, Barber B. Estimating Long-Term Survival of Adults with Philadelphia Chromosome-Negative Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia Treated with Blinatumomab Using Historical Data. Adv Ther. 2017 Jan;34(1):148-155. doi: 10.1007/s12325-016-0447-x. Epub 2016 Nov 21.
citation: Gokbuget N, Dombret H, Ribera JM, Fielding AK, Advani A, Bassan R, Chia V, Doubek M, Giebel S, Hoelzer D, Ifrah N, Katz A, Kelsh M, Martinelli G, Morgades M, O'Brien S, Rowe JM, Stieglmaier J, Wadleigh M, Kantarjian H. International reference analysis of outcomes in adults with B-precursor Ph-negative relapsed/refractory acute lymphoblastic leukemia. Haematologica. 2016 Dec;101(12):1524-1533. doi: 10.3324/haematol.2016.144311. Epub 2016 Sep 1.