Protocol No.UW22117
CA092-1000
Principal InvestigatorKenkre, Vaishalee
PhaseI
Age GroupAdult
ClinicalTrials.GovNCT05688475 (Click to jump to clinicaltrials.gov)
Management Group(s) Early Phase

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

Description
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.

Objective
Primary:
-To provide CC-122 treatment to participants who have participated in a prior protocol investigating CC-122 and receiving clinical benefit from the treatment and to monitor the safety and tolerability of CC-122

Treatment Experimental: CC-122 and Dexamethasone

Specified dose on specified days
Other Names:
Avadomide
BMS-986381

Drug: Dexamethasone
Specified dose on specified days

Key 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.

Applicable Disease Sites
Lymphoma

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital