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

Completed

• Conditions: Acute Lymphoblastic Leukemia

• Registration Number: NCT02010931
• Lead Sponsor: Amgen

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-13
• Primary Completion: 2014-03
• Study Completion: 2014-06
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hematological relapse free survival	Approximately 18 months	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)

Secondary Outcome Measures

Name	Time	Method
overall survival	Approximately 18 months	to estimate overall survival in the 2 sets of patients described in the primary outcome measure, and the first secondary outcome measure.
mortality rate	100 days following allogeniec stem cell transplantation	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
hematological relapse free survival	Approximately 18 months	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

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom