A Rollover Study of CC-122

Bristol-Myers Squibb (BMS)

Status and phase

Active, not recruiting

Phase 1

Conditions

Non-Hodgkin Lymphoma

Treatments

Drug: Dexamethasone

Drug: CC-122

Study type

Interventional

Funder types

Industry

Identifiers

NCT05688475

2022-501855-97 (EudraCT Number)

CA092-1000

U1111-1282-2472 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.