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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-500765-27-00 | Registry Identifier | EU CT Number |
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This extension study is designed to enroll participants with hematologic malignancies who are receiving clinical benefit from tafasitamab treatment in a parent study with tafasitamab..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tafasitamab Dose | Experimental | Treatment with tafasitamab is as per the treatment dose and schedule they received in the parent protocols. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafasitamab | Drug | Treatment with tafasitamab is as per the treatment dose and schedule they received in the parent protocols. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | Defined as any Adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after the last dose of study drug. | up to approximately 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation Call Center (US) | Contact | 1.855.463.3463 | medinfo@incyte.com | |
| Incyte Corporation Call Center (ex-US) | Contact | +800 00027423 | eumedinfo@incyte.com |
| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Director | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Petz Aladar County Teaching Hospital | Recruiting | Győr | 09023 | Hungary | ||
| Hospital S.M. Terni University of Perugia |
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| Label | URL |
|---|---|
| Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab | View source |
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Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
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| Completed |
| Terni |
| 05100 |
| Italy |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Clinica Universitad de Navarra | Completed | Pamplona | 31008 | Spain |
| Gazi University Hospital Gazi University Faculty of Medicine | Recruiting | Ankara | 06500 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000613469 | tafasitamab |
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