A Study of Dinaciclib in Combination With Rituximab in Participants With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (P07974)
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|ClinicalTrials.gov Identifier: NCT01650727|
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : February 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma||Drug: Dinaciclib Biological: Rituximab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Trial of Dinaciclib in Combination With Rituximab in Subjects With Relapsed and Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Dinaciclib + Rituximab
Rituximab will be administered in Cycles 1 and 3-13.
Dinaciclib will be administered in Cycles 2-13.
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.
Other Names: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).
Other Name: Rituxan®
- Number of Participants Experiencing a Dose Limiting Toxicity (DLT) [ Time Frame: Cycles 2 & 3 (Days 29-84) ]