Historical Data Analysis of Complete Remission in Children With R/R Acute Lymphoblastic Leukemia (ALL)

Study Overview
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Brief Summary
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An historical data comparator study for children with relapsed/refactory acute lymphoblastic leukemia (ALL).

Detailed Description
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A retrospective observational study reviewing historical complete remission for pediatric patients who had either relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL)

Official Title
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A Retrospective Pooled Analysis of Complete Remission Among Pediatric Patients With Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

Conditions
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B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

Intervention / Treatment
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* Other: Other: not applicable - observational study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All subjects<br>All subjects will be included in a unique cohort | Other: Other: not applicable - observational study<br>* No intervention exists as this is a retrospective observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | OS following salvage therapy: defined as time to death. | Approx. 1 year | 
| Molecular CR | Defined as MRD <10-4 measured either by PCR or flow cytometry. | Approx. 1 year | 
| Relapse Free Survival (RFS) | Defined as time to relapse or death. | Approx. 1 year | 
| 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 | 
| Receipt of HSCT after salvage treatment | Defined as the receipt of HSCT after chemotherapy or a previously failed HSCT. | Approx. 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALL, pediatric, leukemia, childhood, lymphoblastic, lymphoma, acute, Precursor Cell