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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001437-14 | EudraCT Number | ||
| MK-7965-011 | Other Identifier | Merck Study Number |
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The purpose of this study is to determine the maximum-tolerated dose (MTD) of dinaciclib therapy in combination with rituximab in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dinaciclib + Rituximab | Experimental | Rituximab will be administered in Cycles 1 and 3-13. Dinaciclib will be administered in Cycles 2-13. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dinaciclib | Drug | Dinaciclib is given as a single intravenous (IV) dose on Days 1, 8, and 15 in Cycle 2 through Cycle 13 (28 day cycles) at a starting dose of 7 mg/m^2 up to a maximum dose of 14 mg/m^2. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing a Dose Limiting Toxicity (DLT) | Cycles 2 & 3 (Days 29-84) |
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Inclusion Criteria:
fludarabine or equivalent nucleoside analogue or an alternative regimen
lymphoma (SLL)
agree to use a medically accepted method of contraception should they become
sexually active while participating in the study.
Exclusion Criteria:
malignancy
therapy
transplantation [HSCT] is allowed if fully recovered)
considered by his or her physician to have a 2 year survival expectation
stable, defined as being responsive to corticosteroids or other standard therapy
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25217392 | Result | Fabre C, Gobbi M, Ezzili C, Zoubir M, Sablin MP, Small K, Im E, Shinwari N, Zhang D, Zhou H, Le Tourneau C. Clinical study of the novel cyclin-dependent kinase inhibitor dinaciclib in combination with rituximab in relapsed/refractory chronic lymphocytic leukemia patients. Cancer Chemother Pharmacol. 2014 Nov;74(5):1057-64. doi: 10.1007/s00280-014-2583-9. Epub 2014 Sep 13. |
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|
| Rituximab | Biological | Rituximab 375 mg/m^2 will be administered IV on Day 1, 8, 15 and 22 in Cycle 1 (28 day cycle) and on Day 1 in Cycles 3-13 (28 day cycles). |
|
|
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| 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 |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C553669 | dinaciclib |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| 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 |
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