A Rollover Study of CC-122

Non-Hodgkin Lymphoma Clinical Trial

Official title:

Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating CC-122

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05688475
• Other study ID #: CA092-1000
• Secondary ID: 2022-501855-97U1
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 11, 2023
• Est. completion date: February 25, 2026

Study information

• Verified date: January 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: February 25, 2026
• Est. primary completion date: February 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• 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 Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

Drug:
• CC-122
Specified dose on specified days
• Dexamethasone
Specified dose on specified days

Locations

Country	Name	City	State
France	Local Institution - 300	Bordeaux
France	Local Institution - 301	Marseille cedex
Japan	Local Institution - 500	Koto-ku	Tokyo
Netherlands	Local Institution - 400	Amsterdam
United States	Local Institution - 102	Madison	Wisconsin
United States	Local Institution - 101	Nashville	Tennessee
United States	Local Institution - 100	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  France,  Japan,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with serious adverse events (SAEs) for participants who received at least 1 dose of CC-122		Up to approximately 3 years
Primary	Number of deaths for participants who received at least 1 dose of CC-122		Up to approximately 3 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting