B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Conditions
Keywords
ALL, pediatric, leukemia, childhood, lymphoblastic, lymphoma, acute, Precursor Cell
Brief summary
An historical data comparator study for children with relapsed/refactory acute lymphoblastic leukemia (ALL).
Detailed description
A retrospective observational study reviewing historical complete remission for pediatric patients who had either relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL)
Interventions
OTHEROther: not applicable - observational study
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
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric (age less than 18 years) patients with relapsed or refractory B-cell precursor ALL, specifically those with * 2nd or later relapse after chemotherapy (with no prior transplantation), * Relapse after HSCT, or * Refractory disease * Had treatment for relapsed or refractory disease between 2005-2012 * Has data available on ALL treatment, including number of salvage treatments, response status after therapies, and HSCT
Exclusion criteria
* No CNS involvement at relapse * No previous treatment with blinatumomab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hematological Complete Remission (CR) | Approx. 1 year | To estimate hematological Complete Remission (CR) in pediatric patients with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Approx. 1 year | OS following salvage therapy: defined as time to death. |
| Molecular CR | Approx. 1 year | Defined as MRD \<10-4 measured either by PCR or flow cytometry. |
| Relapse Free Survival (RFS) | Approx. 1 year | Defined as time to relapse or death. |
| Time to hematological CR | Approx. 1 year | Defined as time to unequivocal detection of \>5% leukemia cells in bone marrow as measured by cytological, microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia |
| Receipt of HSCT after salvage treatment | Approx. 1 year | Defined as the receipt of HSCT after chemotherapy or a previously failed HSCT. |
Countries
Austria, Germany, Italy
Outcome results
None listed