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

Amgen

Status: Completed

Conditions: Acute Lymphoblastic Leukemia

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT02010931

20120148

Details and patient eligibility

About

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.

Full 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.

Enrollment: 310 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

310 participants in 1 patient group

primary

Description:

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)