Acute Lymphoblastic Leukemia
Conditions
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.
Interventions
None listed
Sponsors
European EWALL study groups
Amgen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Czechia, France, Germany, Italy, Poland, Russia, Spain, United Kingdom
Outcome results
None listed