Historical Data Analysis of Complete Remission in Children With R/R Acute Lymphoblastic Leukemia (ALL)
- Conditions
- B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
- Registration Number
- NCT02303522
- Lead Sponsor
- Amgen
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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.
Receipt of HSCT after salvage treatment Approx. 1 year Defined as the receipt of HSCT after chemotherapy or a previously failed HSCT.
Trial Locations
- Locations (1)
Research Site
🇮🇹Roma, Italy