Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-cell Lymphoma and Follicular Lymphoma

Part of paid clinical trials in Stanford, California.

Sponsor
Celgene
Study ID
NCT02031419
Phase
PHASE1
Status
Terminated

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CC-122 — DRUG
    2mg or 3 mg administered orally once daily
  • CC-223 — DRUG
    20mg or 30mg administered orally once daily.
  • Rituximab — DRUG
    375 mg/m2 administered intravenously once every 28 days
  • CC-122 — DRUG
    2mg or 3mg administered orally once daily.
  • CC-292 — DRUG
    500 mg twice a day administered orally.
  • Rituximab — DRUG
    375 mg/m2 administered intravenously once every 28 days
  • CC-223 — DRUG
    20mg or 30mg per day administered orally daily.
  • CC-292 — DRUG
    500 mg twice a day administered orally.
  • Rituximab — DRUG
    375 mg/m2 administered intravenously once every 28 days

Study Details

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

Key Dates

Start date
Dec 18, 2013
Status verified
Jan 2024
Primary completion
Dec 12, 2023
Completion
Dec 12, 2023

Study Design

Enrollment
174 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CC-122 + CC-223 +/- rituximab
    CC-122 administered orally once daily at 2mg or 3 mg in combination with CC-223 administered orally once daily at 20mg or 30 mg with or without Rituximab administered by IV once every 28 days
  • Experimental: CC-122 + CC-292 +/- rituximab
    CC-122 administered orally once daily at 2mg or 3 mg in combination with CC-292 administered orally twice daily at 500 mg with or without Rituximab administered by IV once every 28 days
  • Experimental: CC-292 + CC-223 +/- rituximab
    CC-292 administered twice daily at 500 mg in combination with CC-223 administered orally once daily at 20mg or 30 mg with or without Rituximab administered by IV once every 28 days
  • Experimental: CC-122 + rituximab
    CC-122 administered orally once daily in combination with Rituximab.

Primary Outcome Measure

Safety [ Time Frame: From the time of informed consent, throughout dosing period and for 28 days after the last dose of study drug. ]

Locations (8)

FacilityCityStateZIPSite coordinators
Stanford Cancer CenterStanfordCalifornia94305-
Yale Cancer CenterNew HavenConnecticut06510-
Local Institution - 005TampaFlorida33612-
Northwestern UniversityChicagoIllinois60611-
Mayo ClinicRochesterMinnesota55905-
Local Institution - 001NashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-400-
Local Institution - 007MadisonWisconsin53792-

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