Retrospective Analysis of Survival in Adult MRD Positive Acute Lymphoblastic Leukemia Patients

NCT ID: NCT02010931

Last Updated: 2022-09-15

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European EWALL study groups

UNKNOWN

Sponsor Role collaborator

Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Research Site

Brno, , Czechia

Site Status

Research Site

Paris, , France

Site Status

Research Site

Frankfurt am Main, , Germany

Site Status

Research Site

Bologna, , Italy

Site Status

Research Site

Roma, , Italy

Site Status

Research Site

Venezia, , Italy

Site Status

Research Site

Gliwice, , Poland

Site Status

Research Site

Moscow, , Russia

Site Status

Research Site

Badalona, Catalonia, Spain

Site Status

Research Site

London, , United Kingdom

Site Status

Countries

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Czechia France Germany Italy Poland Russia Spain United Kingdom

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.

Reference Type BACKGROUND
PMID: 31876009 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20120148

Identifier Type: -

Identifier Source: org_study_id

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