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Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Course in the Treatment of Acute Myeloid Leukemia With Venetoclax
The aim of this study is to document all patients with AML who are treated with the BCL2 inhibitor Venetoclax outside a clinical trial in all hospitals participating in this registry study in a standardised manner. Data is collected retrospectively and multi-centric. It is neither a therapy study nor is the therapy influenced by this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | Registry study observing clinical and biological characteristics of patients with acute myeloid leukemia who are treated with Venetoclax. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate of Venetoclax treatment. | Overall response rate of Venetoclax treatment (complete remission, complete remission with incomplete regeneration, partial remission) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival during Venetoclax treatment | Event-free survival of patients with relapsed/refractory AML receiving Venetoclax | 5 years |
| Relapse-free survival during Venetoclax treatment | Relapse-free survival of patients with relapsed/refractory AML receiving Venetoclax |
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Inclusion Criteria:
relapsed/refractory AML
Exclusion Criteria:
-
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Patiens with relapsed/refractory AML including patients who received stem cell transplantation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Heuser, MD | Contact | +49511 5323720 | heuser.michael@mh-hannover.de | |
| Rabia Shahswar, MD | Contact | +49511 5329575 | shahswar.rabia@mh-hannover.de |
| Name | Affiliation | Role |
|---|---|---|
| Michael Heuser, MD | Hannover Medical School | Principal Investigator |
| Rabia Shahswar, MD | Hannover Medical School | Principal Investigator |
| Gernot Beutel, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical School Hannover | Recruiting | Hanover | Lower Saxony | 30625 | Germany |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
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Samples with DNA (either bone marrow or peripheral blood)
| 5 years |
| Overall survival during Venetoclax treatment | Overall survival of patients with relapsed/refractory AML receiving Venetoclax | 5 years |
| Hannover Medical School |
| Principal Investigator |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |