Safety Study of CC-292 and Rituximab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the combination of CC-292 and Rituximab in subjects with CLL.
Leukemia Lymphocytic Chronic B-Cell
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Adverse Events [ Time Frame: Up to a year ] [ Designated as safety issue: Yes ]Number of participants with adverse events
- PK-Cmax [ Time Frame: Up to 15 days ] [ Designated as safety issue: No ]Maximum observed plasma concentration
- PK-Tmax [ Time Frame: Up to 15 days ] [ Designated as safety issue: No ]Time to maximum observed plasma concentration of CC-292 in combination with Rituximab.
- PK-λz [ Time Frame: Up to 15 days ] [ Designated as safety issue: No ]Terminal phase rate constant.
- PK-t1/2 [ Time Frame: Up to 15 days ] [ Designated as safety issue: No ]Estimate of the terminal phase half-life in plasma.
- PK-AUC (0-t) [ Time Frame: Up to 15 days ] [ Designated as safety issue: No ]Area under the plasma concentration-time curve from time zero to the last quantifiable time point.
- PK-AUC0-∞ [ Time Frame: Up to 15 days ] [ Designated as safety issue: No ]Area under the plasma concentration time curve from time zero extrapolated to infinity.
- Efficacy [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]To evaluate the preliminary efficacy of CC-292 in combination with Rituximab, including Response Rate, Duration of Response and Progression-Free Survival
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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 1-28Drug: Rituximab
Cohort 1: Rituximab once per cycle Cohort 2: Rituximab once per cycle
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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:||Pilar Nava-Prada, MD, PhD||Celgene Corporation|