Retrospective Analysis of Survival in Adult MRD Positive Acute Lymphoblastic Leukemia Patients
NCT ID: NCT02010931
Last Updated: 2022-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
310 participants
OBSERVATIONAL
2013-09-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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primary
subjects who are 18 years or older, who have minimal residual disease detected by PCR at a level of 1/10-3 or higher, who are free form allogeneic stem cell transplantation until hematological relapse or until 18 months after minimal residual disease detection (whichever comes first)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Years
ALL
No
Sponsors
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European EWALL study groups
UNKNOWN
Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Brno, , Czechia
Research Site
Paris, , France
Research Site
Frankfurt am Main, , Germany
Research Site
Bologna, , Italy
Research Site
Roma, , Italy
Research Site
Venezia, , Italy
Research Site
Gliwice, , Poland
Research Site
Moscow, , Russia
Research Site
Badalona, Catalonia, Spain
Research Site
London, , United Kingdom
Countries
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References
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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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20120148
Identifier Type: -
Identifier Source: org_study_id
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