Historical Data Analysis of Hematological Remission and Survival in Adults With R/R Acute Lymphoblastic Leukemia
Study Details
Study Description
Brief Summary
A retrospective analysis of historical data looking at hematological remission and survival in adult relapsed / refractory B-precursor acute lymphoblastic leukemia patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| All subjects All subjects |
Other: Not applicable - observational study
No intervention exists as this is a retrospective observational study
|
Outcome Measures
Primary Outcome Measures
- hematological complete remission [Approx 1 year]
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)
Secondary Outcome Measures
- overall survival [Approx 1 year]
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
- duration of complete remission [Approx 1 year]
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
- proportion of patients receiving allogeneic hematological stem cell transplantation [Approx 1 year]
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
Eligibility Criteria
Criteria
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
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initial diagnosis of acute lymphoblastic leukemia in the year 1990 or later
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No CNS involvement at relapse
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No isolated extramedullary relapse
-
Other inclusion criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Boston | Massachusetts | United States | 02215 |
| 2 | Research Site | Cleveland | Ohio | United States | 44195 |
| 3 | Research Site | Brno | Czech Republic | 625 00 | |
| 4 | Research Site | Paris Cedex 10 | France | 75475 | |
| 5 | Research Site | Frankfurt am Main | Germany | 60590 | |
| 6 | Research Site | Bologna | Italy | 40138 | |
| 7 | Research Site | Venezia | Italy | 30174 | |
| 8 | Research Site | Gliwice | Poland | 44-101 | |
| 9 | Research Site | Badalona | Cataluña | Spain | 08916 |
| 10 | Research Site | London | United Kingdom | NW3 2PF |
Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20120310