Acute Lymphoblastic Leukemia
Conditions
Brief summary
A retrospective analysis of historical data looking at hematological remission and survival in adult relapsed / refractory B-precursor acute lymphoblastic leukemia patients.
Detailed description
A retrospective observational study reviewing historical survival data (hematological remission and survival) for adult patients who have either relapsed or refractory B-precursor acute lymphoblastic leukemia. Data are aggregated across multiple countries and study sites in the EU and US
Interventions
No intervention exists as this is a retrospective observational study
Sponsors
Amgen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients with relapsed / refractory B-precursor acute lymphoblastic leukemia * age 15 or older at time of de novo (initial) diagnosis of acute lymphoblastic leukemia * initial diagnosis of acute lymphoblastic leukemia in the year 1990 or later * No CNS involvement at relapse * No isolated extramedullary relapse * Other inclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hematological complete remission | Approx 1 year | To estimate the proportion of patients in hematological complete remission (CR) for R/R Philadelphia chromosome negative (Ph-) B-precursor ALL patients following relapse or salvage treatment, excluding patients with a first remission duration of \>12 months in first salvage (ie, patients with late relapse in first salvage) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | Approx 1 year | to estimate overall survival for relapsed / refractory philadelphia negative B-precursor acute lymphoblastic leukemia patients following salvage treatment, excluding patients with late relapse in first salvage |
| duration of complete remission | Approx 1 year | to estimate the duration of complete remission for philadelphia negative patients following treatment for relapsed / refractory B-precursor acute lymphoblastic leukemia, excluding patients with late relapse in first salvage |
| proportion of patients receiving allogeneic hematological stem cell transplantation | Approx 1 year | estimate the proportion of patients receiving allogeneic hematological stem cell transplantation for philadelphia negative patients following treatment for relapsed / refractory B-precursor acute lymphoblastic leukemia excluding those with late relapse in first salvage |
Countries
Czechia, France, Germany, Italy, Poland, Spain, United Kingdom, United States
Outcome results
None listed