Trials / Completed
CompletedNCT01650727
A Study of Dinaciclib in Combination With Rituximab in Participants With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (P07974)
A Phase 1b Trial of Dinaciclib in Combination With Rituximab in Subjects With Relapsed and Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dinaciclib | 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. |
| BIOLOGICAL | Rituximab | 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). |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2013-10-01
- Completion
- 2013-10-01
- First posted
- 2012-07-26
- Last updated
- 2015-02-10
Source: ClinicalTrials.gov record NCT01650727. Inclusion in this directory is not an endorsement.