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| Name | Class |
|---|---|
| Racura Oncology Ltd | INDUSTRY |
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Induction of response in patients with AML that are either primary resistant (failed induction and or salvage therapy) or relapsed including post allogeneic stem cell transplantation and failed salvage therapy or cannot receive additional anthracycline .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bisantrene | Experimental | patients will receive bisantrene 250mg/m2/d for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bisantrene | Drug | The patients will receive bisantrene 250mg/m2/d for 7 days in conjunction with the conventional supportive care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival will be calculated from the day of bisantrene administration until death or last follow-up. | 24 months |
| Leukemia-free survival | Leukemia-free survival will be calculated from the day of bisantrene administration until relapse, death of any cause, or last follow-up. | 24 months |
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Inclusion Criteria:
Disease-related:
Demographic:
Exclusion Criteria:
Disease-related
Patients with grade III-IV GVHD will be excluded from the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaim Sheba Medical Center | Ramat Gan | 57261 | Israel |
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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 |
|---|---|
| C031404 | bisantrene |
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The patientswith Rel /Ref AML will receive bisantrene in conjunction with the conventional supportive care. In the event of a CR, patients will receive a 3-day consolidation course of bisantrene 250mg/m2/d (optional).
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |