CC-122 for Non-Hodgkin's Lymphoma

Recruiting at 14 trial locations

Overseen By First line of the email MUST contain the NCT# and Site #.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Must be taking: CC-122

Disqualifiers: No clinical benefit, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial provides CC-122 treatment to participants who have benefited from it in previous trials for a long period. The study aims to monitor their safety and how well they tolerate the medication. CC-122 works by enhancing the immune system to fight diseases.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the trial is for participants already receiving CC-122, it seems likely you would continue with this medication.

What safety data exists for CC-122 in humans?

The safety of new drugs for lymphoid malignancies, like CC-122, requires careful attention due to potential adverse events and drug interactions. While newer treatments may have fewer side effects than older chemotherapy, they still have unique toxicity profiles that need to be managed carefully. ^{1 2 3 4 5}

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for people with Non-Hodgkin's Lymphoma who are already participating in other CC-122 studies and benefiting from the treatment without experiencing disease progression or reasons to stop as per previous study rules.

Inclusion Criteria

I can handle the study treatment without my condition getting worse or needing to stop due to the study's rules.

Participant who has participated in previous CC-122 protocol and is deemed by the investigator to be deriving benefit from CC-122 as defined by the previous protocol

I am currently in a CC-122 trial that has met its goals.

Exclusion Criteria

Women who are breastfeeding

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

Participants not receiving clinical benefit as assessed by the investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue receiving CC-122 treatment to monitor safety and tolerability

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CC-122
• Dexamethasone

Trial Overview The trial continues providing a drug called CC-122 to participants from earlier trials. It aims to understand long-term safety and how well patients tolerate continued use of this medication over time.

Participant Groups

Group I: CC-122 and Dexamethasone Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

Monoclonal antibody therapies for advanced primary cutaneous lymphomas show promising efficacy and a more manageable safety profile compared to traditional polychemotherapy, which often has severe side effects.

Despite their advantages, the safety of these monoclonal antibodies must be carefully evaluated, as adverse effects can arise from targeting not only tumor cells but also benign T and B cells, and many patients have undergone multiple treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Reactions of Antibody-Therapy for Primary Cutaneous Lymphomas: Rituximab, Brentuximab Vedotin, Alemtuzumab, and Mogamulizumab. Saulite, I., Guenova, E., Hoetzenecker, W.[2019]

Recent advancements in the treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) have led to improved patient responses and survival rates, but adverse events remain a significant concern.

New targeted therapies are being developed that may reduce the hematologic toxicity seen with traditional chemotherapy, yet these newer agents also have unique toxicity profiles that require careful management and monitoring during clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accurate reporting of adverse events in chronic lymphocytic leukemia and non-Hodgkin lymphoma. Cheson, BD., Rai, KR., Friedberg, JW.[2012]

References

1. England pubmed.ncbi.nlm.nih.gov

New drugs and pharmacological interactions in real life. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Reactions of Antibody-Therapy for Primary Cutaneous Lymphomas: Rituximab, Brentuximab Vedotin, Alemtuzumab, and Mogamulizumab. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Accurate reporting of adverse events in chronic lymphocytic leukemia and non-Hodgkin lymphoma. [2012]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Frequency and impact of grade three or four toxicities of novel agents on outcomes of older patients with chronic lymphocytic leukemia and non-Hodgkin lymphoma (alliance A151611). [2019]

5. Czech Republic pubmed.ncbi.nlm.nih.gov

[Rituximab infusion-related toxicity in patients with chronic lymphocytic leukemia]. [2018]