Clinical trial NCT02010931: Retrospective Analysis of Survival in Adult MRD Positive Acute Lymphoblastic Leukemia Patients
Official title: A Retrospective Analysis of Hematological Relapse Free Survival and Overall Survival in Adult Patients With Philadelphia-Negative B-Precursor Acute Lymphoblastic Leukemia in Complete Hematological Remission With Minimal Residual Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: European EWALL study groups
First posted: 2013-12-13
Enrollment: 310
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: adult acute lymphoblastic leukemia

Brief summary: A retrospective analysis of historical data looking at relapse free survival and overall survival rates in adult philadelphia negative B-pre-cursor acute lymphoblastic leukemia patients.

Detailed description: A retrospective observational study reviewing historical survival data (relapse free survival and overall survival) for adult patients who have philadelphia negative B-precursor acute lymphoblastic leukemia, and are in complete hematological remission with minimal residual disease.

Eligibility criteria: Inclusion Criteria:

* patients with Philadelphia-negative B-Precursor Acute Lyphmoblastic Leukemia in complete hematological remission defined as less than 5% blasts in bone marrow after at least 3 intensive chemotherapy blocks (i.e. any standard or investigational regimen according to adult protocols as long as 3 age appropriate chemotherapy blocks were given, this also includes relapse treatment
* detection of minimal residual disease (molecular failure or molecular relapse) at a level of greater than or equal to 10\*(-4) by PCR or greater than or equal to 10\*(-3) by flow cytometry at a reference lab
* Age 15 or greater at time of initial diagnosis with acute lymphoblastic leukemia. For patients aged 15-17 treatment according to adult protocols is required
* Initial diagnosis in the year 2000 or later
* History of acute lymphoblastic leukemia treatment (including response to first therapy, number of prior relapses) is available
* Relapse status and disease follow up after timepoint of minimal residual disease detection is available

Exclusion Criteria:

* Patients with extramedullary disease at timepoint of minimal residual disease detection
* Use of Blinatumomab within 18 months of minimal residual disease detection
* Allogeneic hematopoietic stem cell transplantation prior to minimal residual disease detection at the required level

Primary outcomes:
measure: hematological relapse free survival
timeFrame: Approximately 18 months
Secondary outcomes:
measure: hematological relapse free survival
timeFrame: Approximately 18 months
measure: overall survival
timeFrame: Approximately 18 months
measure: mortality rate
timeFrame: 100 days following allogeniec stem cell transplantation
Other outcomes:
Locations:
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: Roma
country: Italy
facility: Research Site
city: Venezia
country: Italy
facility: Research Site
city: Gliwice
country: Poland
facility: Research Site
city: Moscow
country: Russian Federation
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: Gokbuget N, Dombret H, Giebel S, Bruggemann M, Doubek M, Foa R, Hoelzer D, Kim C, Martinelli G, Parovichnikova E, Maria Ribera J, Schoonen M, Tuglus C, Zugmaier G, Bassan R. Blinatumomab vs historic standard-of-care treatment for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukaemia. Eur J Haematol. 2020 Apr;104(4):299-309. doi: 10.1111/ejh.13375. Epub 2020 Jan 24.