A Rollover Study of CC-122
- Conditions
- Non-Hodgkin Lymphoma
- Interventions
- Registration Number
- NCT05688475
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of the study is to provide CC-122 treatment to participants who have been receiving treatment in other CC-122 clinical trials investigating CC-122 for more than 5 years (CC-122-ST-001 \[NCT01421524\], CC-122-ST-002 \[NCT02509039\], CC-122-DBCL-001 \[NCT02031419\], and CC-122-NHL-001 \[NCT02417285\]), receiving clinical benefit from the treatment and to monitor the safety and tolerability of CC-122.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 12
- Participant who is currently receiving CC-122 on another CC-122 clinical trial that has met its primary and secondary endpoints.
- Participant who has participated in previous CC-122 protocol (including CC-122-ST-001 [NCT01421524], CC-122-ST-002 [NCT02509039], CC-122-DBCL-001 [NCT02031419], and CC-122-NHL-001 [NCT02417285]), and is deemed by the investigator to be deriving benefit from CC-122 as defined by the previous protocol.
- Participant who is able to tolerate study therapy and has not yet experienced progressive disease or any treatment discontinuation criteria of the Parent Study.
Key
- Participant is not eligible for CC-122 treatment as per the Parent Study.
- Participants not receiving clinical benefit as assessed by the investigator. Any clinical AE, laboratory abnormality, or intercurrent illness which, in the opinion of the investigator, indicates that participation in the study is not in the best interest of the participant.
- Women who are breastfeeding.
Note: Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CC-122 and Dexamethasone CC-122 - CC-122 and Dexamethasone Dexamethasone -
- Primary Outcome Measures
Name Time Method Number of participants with serious adverse events (SAEs) for participants who received at least 1 dose of CC-122 Up to approximately 3 years Number of deaths for participants who received at least 1 dose of CC-122 Up to approximately 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Local Institution - 400
🇳🇱Amsterdam, Netherlands
Local Institution - 500
🇯🇵Koto-ku, Tokyo, Japan
Local Institution - 100
🇺🇸New York, New York, United States
Local Institution - 301
🇫🇷Marseille cedex, France
Local Institution - 102
🇺🇸Madison, Wisconsin, United States
Local Institution - 101
🇺🇸Nashville, Tennessee, United States
Local Institution - 300
🇫🇷Bordeaux, France