Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| European EWALL study groups | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A retrospective analysis of historical data looking at relapse free survival and overall survival rates in adult philadelphia negative B-pre-cursor acute lymphoblastic leukemia patients.
A retrospective observational study reviewing historical survival data (relapse free survival and overall survival) for adult patients who have philadelphia negative B-precursor acute lymphoblastic leukemia, and are in complete hematological remission with minimal residual disease.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| primary | subjects who are 18 years or older, who have minimal residual disease detected by PCR at a level of 1/10-3 or higher, who are free form allogeneic stem cell transplantation until hematological relapse or until 18 months after minimal residual disease detection (whichever comes first) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| hematological relapse free survival | to estimate the hematological relapse free survival in patients who are 18 years or older, who have minimal residual disease detected by PCR at a level of 1/10-3 or higher, who are free form allogeneic stem cell transplantation until hematological relapse or until 18 months after minimal residual disease detection (whichever comes first) | Approximately 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| hematological relapse free survival | to estimate the hematological relapse free survival in patients who are 15 years or older, who have minimal residual disease regardless of detection method, with or without stem cell transplantation within18 months of minimal residual disease detection | Approximately 18 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
adult acute lymphoblastic leukemia
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Brno | 625 00 | Czechia | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31876009 | Background | Gokbuget N, Dombret H, Giebel S, Bruggemann M, Doubek M, Foa R, Hoelzer D, Kim C, Martinelli G, Parovichnikova E, Maria Ribera J, Schoonen M, Tuglus C, Zugmaier G, Bassan R. Blinatumomab vs historic standard-of-care treatment for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukaemia. Eur J Haematol. 2020 Apr;104(4):299-309. doi: 10.1111/ejh.13375. Epub 2020 Jan 24. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| overall survival |
to estimate overall survival in the 2 sets of patients described in the primary outcome measure, and the first secondary outcome measure. |
| Approximately 18 months |
| mortality rate | to estimate the mortality rate (proportion) at 100 days following allogeneic stem cell transplantation in patients who received an allogeneic stem cell transplantation within 18 months after minimal residual disease detection | 100 days following allogeniec stem cell transplantation |
| Paris |
| 75475 |
| France |
| Research Site | Frankfurt am Main | 60590 | Germany |
| Research Site | Bologna | 40138 | Italy |
| Research Site | Roma | 00161 | Italy |
| Research Site | Venezia | 30174 | Italy |
| Research Site | Gliwice | 44-101 | Poland |
| Research Site | Moscow | 125167 | Russia |
| Research Site | Badalona | Catalonia | 08916 | Spain |
| Research Site | London | NW3 2PF | United Kingdom |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |