A Rollover Study of CC-122

NCT ID: NCT05688475

Last Updated: 2025-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-11

Study Completion Date

2026-02-25

Brief Summary

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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

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Conditions

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Non-Hodgkin Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CC-122 and Dexamethasone

Group Type EXPERIMENTAL

CC-122

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Interventions

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CC-122

Specified dose on specified days

Intervention Type DRUG

Dexamethasone

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Avadomide BMS-986381

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 100

New York, New York, United States

Site Status

Local Institution - 101

Nashville, Tennessee, United States

Site Status

Local Institution - 102

Madison, Wisconsin, United States

Site Status

Local Institution - 300

Bordeaux, , France

Site Status

Local Institution - 301

Marseille, , France

Site Status

Local Institution - 500

Koto-ku, Tokyo, Japan

Site Status

Local Institution - 400

Amsterdam, , Netherlands

Site Status

Countries

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United States France Japan Netherlands

Related Links

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Other Identifiers

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2022-501855-97

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1282-2472

Identifier Type: REGISTRY

Identifier Source: secondary_id

CA092-1000

Identifier Type: -

Identifier Source: org_study_id

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