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The study will be a prospective open-label single-center study in previously treated patients with Acute Myeloid Leukemia (AML) or Acute Lymphoid Leukemia (ALL). Treatment efficacy and safety of the combination of Oshadi D (DNase in Oshadi carrier) and Oshadi R (RNase in Oshadi carrier) with Salvage Chemotherapy will be evaluated. Oshadi D and Oshadi R were shown to have anti-tumor activity and good safety profile.
Patients will receive Oshadi D and Oshadi R oral treatment combined with salvage chemotherapy. Patient will be evaluated throughout the study for safety and tolerance to multiple dose regimens of Oshadi D and Oshadi R.
Efficacy will be determined by percentage of bone marrow blasts assessment at day 28 post therapy initiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 'Oshadi D & Oshadi R; salvage therapy' | Experimental | Oshadi D (180mg/tid) & Oshadi R (180mg/tid) will be administrated orally; Salvage therapy - HAM: Hi dose cytosar (5 or 6 days) and mitoxantrone (2 or 3 days) will be administrated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oshadi D & Oshadi R; | Drug | Oshadi D (180mg/TID) & Oshadi R (180mg TID) will be administrated; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation. | Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moshe Gatt, MD | Hadassah Medical Center, Jrusalem, Israel | Principal Investigator |
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| salvage therapy cytosar and mitoxantrone | Drug | Salvage therapy - HAM: Hi dose cytosar (5 or 6 days) and mitoxantrone (2 or 3 days) |
|
|
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007945 | Leukemia, Lymphoid |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| 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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| ID | Term |
|---|---|
| D000970 | Antineoplastic Agents |
| D008942 | Mitoxantrone |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
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