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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | All subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not applicable - observational study | Other | No intervention exists as this is a retrospective observational study |
|
| 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 |
| 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 |
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Inclusion Criteria:
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Adults with relapsed / refractory B-precursor acute lymphoblastic leukemia identified in study group databases from multiple sites in EU and US
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Boston | Massachusetts | 02215 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27873237 | Derived | Barlev A, Lin VW, Katz A, Hu K, Cong Z, Barber B. Estimating Long-Term Survival of Adults with Philadelphia Chromosome-Negative Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia Treated with Blinatumomab Using Historical Data. Adv Ther. 2017 Jan;34(1):148-155. doi: 10.1007/s12325-016-0447-x. Epub 2016 Nov 21. | |
| 27587380 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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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 |
| Cleveland |
| Ohio |
| 44195 |
| United States |
| Research Site | Brno | 625 00 | Czechia |
| Research Site | Paris | 75475 | France |
| Research Site | Frankfurt am Main | 60590 | Germany |
| Research Site | Bologna | 40138 | Italy |
| Research Site | Venezia | 30174 | Italy |
| Research Site | Gliwice | 44-101 | Poland |
| Research Site | Badalona | Catalonia | 08916 | Spain |
| Research Site | London | NW3 2PF | United Kingdom |
| Gokbuget N, Dombret H, Ribera JM, Fielding AK, Advani A, Bassan R, Chia V, Doubek M, Giebel S, Hoelzer D, Ifrah N, Katz A, Kelsh M, Martinelli G, Morgades M, O'Brien S, Rowe JM, Stieglmaier J, Wadleigh M, Kantarjian H. International reference analysis of outcomes in adults with B-precursor Ph-negative relapsed/refractory acute lymphoblastic leukemia. Haematologica. 2016 Dec;101(12):1524-1533. doi: 10.3324/haematol.2016.144311. Epub 2016 Sep 1. |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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