First study, at multiple clinical centers, exploring the effects of different combinations of compounds (CC-122, CC-223 ,CC-292 and rituximab) to treat Diffuse Large B Cell Lymphoma (DLBCL) and Follicular Lymphoma
Study CC-122-DLBCL-001 is a Phase 1b dose escalation and expansion clinical study of CC 122, CC-223 and CC-292 administered orally as doublets with or without rituximab, in participants with relapsed/refractory DLBCL who have failed standard therapy. In expansion phase, selected combination will be administered to lenalidomide naïve FL participants and lenalidomide exposed FL participants in addition to relapsed/refractory DLBCL participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
Stanford Cancer Center
Stanford, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Local Institution - 005
Tampa, Florida, United States
Safety
To determine safety profiles and dose-limiting toxicities of study drug combinations using NCI CTCAE v4.
Time frame: From the time of informed consent, throughout dosing period and for 28 days after the last dose of study drug.
Efficacy
Tumor response rates using Cheson Revised Response Criteria for Malignant Lymphoma
Time frame: Every 2-3 months until proof of tumor progression
Pharmacokinetics - CC-223 and CC-292 interaction
Area under the plasma concentration-time curve
Time frame: Day 1, Day 15
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2mg or 3mg administered orally once daily.
500 mg twice a day administered orally.
375 mg/m2 administered intravenously once every 28 days
20mg or 30mg per day administered orally daily.
500 mg twice a day administered orally.
375 mg/m2 administered intravenously once every 28 days
Northwestern University
Chicago, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Local Institution - 001
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Local Institution - 007
Madison, Wisconsin, United States
Local Institution - 402
Edmonton, Alberta, Canada
Local Institution - 400
Toronto, Ontario, Canada
...and 6 more locations