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Participants with acute myelogenous leukemia (AML) will be randomized to SCH 727965 or gemtuzumab ozogamicin. All participants with acute lymphoblastic leukemia (ALL) will receive SCH 727965. Part 1 of the study will determine the activity of SCH 727965 treatment in participants with AML and participants with ALL. Part 2 of the study will determine the activity of SCH 727965 treatment in participants with AML who experienced disease progression after standard treatment with gemtuzumab ozogamicin during Part 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with AML randomized to SCH 727965 | Experimental |
| |
| Participants with AML randomized to gemtuzumab ozogamicin | Active Comparator |
| |
| AML treated w/ SCH 727965 after prog. on gemtuzumab ozogamicin | Experimental |
| |
| Participants with ALL treated with SCH 727965 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCH 727965 | Drug | SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate of initial treatment with SCH 727965 in subjects with AML or ALL. | Time to identified response or disease progression on SCH 727965 in Part 1 (approx. 5 months). | |
| Overall response rate in participants with AML treated with SCH 727965 after disease progression on comparator. | Time to identified response or disease progression on SCH 727965 in Part 2 (approx. 5 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to disease progression for initial treatment with SCH 727965 in subjects with AML or ALL. | Time to identified disease progression on SCH 727965 in Part 1 (approx. 5 months). | |
| Overall response rate and time to progression of treatment with gemtuzumab ozogamicin in subjects with AML. |
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Inclusion Criteria:
For participants with AML:
For participants with ALL:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23949430 | Result | Gojo I, Sadowska M, Walker A, Feldman EJ, Iyer SP, Baer MR, Sausville EA, Lapidus RG, Zhang D, Zhu Y, Jou YM, Poon J, Small K, Bannerji R. Clinical and laboratory studies of the novel cyclin-dependent kinase inhibitor dinaciclib (SCH 727965) in acute leukemias. Cancer Chemother Pharmacol. 2013 Oct;72(4):897-908. doi: 10.1007/s00280-013-2249-z. Epub 2013 Aug 15. |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C553669 | dinaciclib |
| D000079982 | Gemtuzumab |
| ID | Term |
|---|---|
| D000080084 | Calicheamicins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Gemtuzumab ozogamicin | Drug | Gemtuzumab ozogamicin 9 mg/m2 IV on Day 1 and Day 15. |
|
|
| Time to identified response or disease progression on gemtuzumab ozogamicin (approx. 5 months). |
| Time to disease progression for treatment with gemtuzumab ozogamicin in participants with AML. | Time to identified disease progression on gemtuzumab ozogamicin (approx. 5 months). |
| Time to disease progression in participants with AML treated with SCH 727965 after disease progression on gemtuzumab ozogamicin | Time to identified disease progression on SCH 727965 in Part 2 (approx. 5 months). |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D061067 |
| Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |