Safety Study of CC-292 and Rituximab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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|ClinicalTrials.gov Identifier: NCT01744626|
Recruitment Status : Completed
First Posted : December 7, 2012
Last Update Posted : April 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphocytic Chronic B-Cell||Drug: CC-292 Drug: Rituximab||Phase 1|
This dose finding study uses a 3 + 3 dose escalation and expansion design to establish the recommended Phase 2 dose (RP2D). Treatment will consist 28 day treatment cycles with a single Rituximab infusion per cycle for 6 cycles and twice daily (days 1-28) administration of CC-292 with a starting dose cohort of 375mg twice a day. Following safety review of the data from the initial cohort and confirmation that the initial dose is tolerable, the next dose level will be enrolled with a once per cycle Rituximab infusion for 6 cycles and twice daily CC-292 at 500 mg.
Determination of the maximum tolerated dose and/or optimal biologic effect will be used to establish a dose for evaluation in an expansion cohort of 24 subjects. Evaluation of the data for subjects in the expansion cohorts will result in establishment of a RP2D.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b, Multi-center, Open Label, Study to Determine the Safety and Activity of CC-292 in Combination With Rituximab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma.|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: CC-292 with Rituximab
Cohort 1: 375 mg CC-292 will be administered twice a day on Days 1-28 Cohort 2: 500 mg CC-292 will be administered twice a day on Days 1-28
Cohort 1: Rituximab once per cycle Cohort 2: Rituximab once per cycle
- Adverse Events [ Time Frame: Up to a year ]Number of participants with adverse events
- PK-Cmax [ Time Frame: Up to 15 days ]Maximum observed plasma concentration
- PK-Tmax [ Time Frame: Up to 15 days ]Time to maximum observed plasma concentration of CC-292 in combination with Rituximab.
- PK-λz [ Time Frame: Up to 15 days ]Terminal phase rate constant.
- PK-t1/2 [ Time Frame: Up to 15 days ]Estimate of the terminal phase half-life in plasma.
- PK-AUC (0-t) [ Time Frame: Up to 15 days ]Area under the plasma concentration-time curve from time zero to the last quantifiable time point.
- PK-AUC0-∞ [ Time Frame: Up to 15 days ]Area under the plasma concentration time curve from time zero extrapolated to infinity.
- Efficacy [ Time Frame: Up to 2 years ]To evaluate the preliminary efficacy of CC-292 in combination with Rituximab, including Response Rate, Duration of Response and Progression-Free Survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744626
|United States, Alabama|
|Clearview Cancer Institute|
|Huntsville, Alabama, United States, 35805|
|United States, Indiana|
|Horizon Oncology Research, Inc|
|Lafayette, Indiana, United States, 47905|
|United States, New Jersey|
|Hackensack, New Jersey, United States, 07601|
|United States, Tennessee|
|The West Clinic|
|Memphis, Tennessee, United States, 38120|
|Ulm, Bayern, Germany, 89070|
|Städt. Klinikum München-Schwabing|
|Bayern, Germany, 80804|
|Bayern, Germany, 907080|
|Köln, Germany, 50924|
|Study Director:||Kenichi Takeshita, MD||Celgene|