B-cell Precursor Acute Lymphoblastic Leukemia (ALL) Clinical Trial
Official title:
A Retrospective Pooled Analysis of Complete Remission Among Pediatric Patients With Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
| NCT number | NCT02303522 |
| Other study ID # | 20120299 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 9, 2014 |
| Est. completion date | January 22, 2015 |
| Verified date | May 2020 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
An historical data comparator study for children with relapsed/refactory acute lymphoblastic leukemia (ALL).
| Status | Completed |
| Enrollment | 207 |
| Est. completion date | January 22, 2015 |
| Est. primary completion date | January 22, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 17 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Research Site | Wien | |
| Germany | Research Site | Berlin | |
| Italy | Research Site | Roma |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
Austria, Germany, Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hematological Complete Remission (CR) | To estimate hematological Complete Remission (CR) in pediatric patients with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL) | Approx. 1 year | |
| Secondary | Overall survival | OS following salvage therapy: defined as time to death. | Approx. 1 year | |
| Secondary | Molecular CR | Defined as MRD <10-4 measured either by PCR or flow cytometry. | Approx. 1 year | |
| Secondary | Relapse Free Survival (RFS) | Defined as time to relapse or death. | Approx. 1 year | |
| Secondary | Time to hematological CR | 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 | Approx. 1 year | |
| Secondary | Receipt of HSCT after salvage treatment | Defined as the receipt of HSCT after chemotherapy or a previously failed HSCT. | Approx. 1 year |