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

Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010931
• Other study ID #: 20120148
• Status: Completed
• Start date: September 2013
• Est. completion date: June 2014

Study information

• Verified date: September 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Czechia	Research Site	Brno
France	Research Site	Paris Cedex 10
Germany	Research Site	Frankfurt am Main
Italy	Research Site	Bologna
Italy	Research Site	Roma
Italy	Research Site	Venezia
Poland	Research Site	Gliwice
Russian Federation	Research Site	Moscow
Spain	Research Site	Badalona	Cataluña
United Kingdom	Research Site	London

Sponsors (2)

Lead Sponsor	Collaborator
Amgen	European EWALL study groups

Countries where clinical trial is conducted

Czechia,  France,  Germany,  Italy,  Poland,  Russian Federation,  Spain,  United Kingdom, 

References & Publications (1)

Gökbuget N, Dombret H, Giebel S, Brüggemann 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. Erratum in: Eur J Haematol. 2021 Apr;106(4):593. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hematological relapse free survival	to estimate the hematological relapse free survival in patients 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)	Approximately 18 months
Secondary	hematological relapse free survival	to estimate the hematological relapse free survival in patients who are 15 years or older, who have minimal residual disease regardless of detection method, with or without stem cell transplantation within18 months of minimal residual disease detection	Approximately 18 months
Secondary	overall survival	to estimate overall survival in the 2 sets of patients described in the primary outcome measure, and the first secondary outcome measure.	Approximately 18 months
Secondary	mortality rate	to estimate the mortality rate (proportion) at 100 days following allogeneic stem cell transplantation in patients who received an allogeneic stem cell transplantation within 18 months after minimal residual disease detection	100 days following allogeniec stem cell transplantation

External Links

•   AmgenTrials clinical trials website