Historical Data Analysis of Hematological Remission and Survival in Adults With R/R Acute Lymphoblastic Leukemia

Study Overview
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Brief Summary
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A retrospective analysis of historical data looking at hematological remission and survival in adult relapsed / refractory B-precursor acute lymphoblastic leukemia patients.

Detailed Description
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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

Official Title
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An Analysis of Historical Data on Hematological Remission and Survival Among Adult Patients With Relapsed / Refractory B-Precursor Acute Lymphoblastic Leukemia

Conditions
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Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Other: Not applicable - observational study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 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 | 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 | 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) | Approx 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | 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 | Approx 1 year | 
| duration of complete remission | 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 | Approx 1 year | 
| proportion of patients receiving allogeneic hematological stem cell transplantation | 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 | Approx 1 year |