CC-122 for Non-Hodgkin's Lymphoma

Not currently recruiting at 15 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a treatment called CC-122 for individuals with Non-Hodgkin's Lymphoma, a cancer that begins in the lymphatic system. It aims to continue treatment for those who have used CC-122 in other studies and experienced positive results. Participants should already benefit from CC-122 in previous studies and not have worsening disease. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to contribute to groundbreaking research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CC-122 has undergone safety testing in various studies. In one study, two patients experienced serious side effects: a severe drop in white blood cells at a dose of 3 mg and a severe tumor flare at a dose of 4 mg. While these side effects are important to note, they are uncommon, as most patients did not experience such severe reactions. Another study examined the safety of CC-122 for conditions like Non-Hodgkin's Lymphoma, emphasizing safety as a key concern due to potential side effects.

Dexamethasone, used alongside CC-122, is generally safe when used properly. Most side effects depend on the dose and duration of use. It is often used to treat lymphoma and can help reduce some treatment-related symptoms.

Overall, while CC-122 can cause serious side effects, many patients tolerate it well. Dexamethasone is widely used and has a well-known safety record. Always consult a healthcare provider to fully understand what to expect. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about CC-122 for Non-Hodgkin's Lymphoma because it represents a novel approach compared to traditional treatments like chemotherapy and rituximab. Unlike most treatments that focus on killing cancer cells directly, CC-122 works by modulating the immune system, potentially enhancing the body's natural ability to fight cancer. This unique mechanism of action could lead to better-targeted therapies with fewer side effects. Additionally, when combined with dexamethasone, a steroid that reduces inflammation, CC-122 may increase treatment effectiveness, offering new hope for patients with this condition.

What is the effectiveness track record for CC-122 in treating Non-Hodgkin's Lymphoma?

Research has shown that CC-122 holds promise for treating non-Hodgkin's lymphoma (NHL). One study found that two-thirds of patients responded positively when CC-122 was combined with another drug. In this trial, participants will receive a combination of CC-122 and Dexamethasone. CC-122 alone has also shown early signs of effectiveness in NHL patients. Dexamethasone, a common cancer treatment, has been associated with good results in similar conditions. Together, these treatments offer hope for better management of NHL symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

Citations

1. ashpublications.org ashpublications.org/ashclinicalnews/news/3735/CC-122-Plus-Obinutuzumab-An-Effective-Chemotherapy

CC-122 Plus Obinutuzumab: An Effective, Chemotherapy ... At 12-month follow-up, two-thirds of patients responded to this chemotherapy-free regimen without new safety signals. "Patients with relapsed/refractory NHL, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9175947/

Phase Ib study of avadomide (CC‐122) in combination with ... Avadomide has shown promising preclinical activity and phase I clinical efficacy as a monotherapy in NHL and combination with the anti‐CD20 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02509039

A Study of CC-122 to Assess the Safety and Tolerability in ... This is a phase 1, multicenter, open-label, dose-escalation study that will evaluate the safety, tolerability, (Pharmacokinetics) PK, and preliminary efficacy ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32758434/

Avadomide plus obinutuzumab in patients with relapsed or ... We aimed to examine the safety and preliminary activity of avadomide plus obinutuzumab in patients with relapsed or refractory non-Hodgkin lymphoma.

5. sciencedirect.com sciencedirect.com/science/article/pii/S000649711980928X

CC-122, a Novel Cereblon Modulating Agent, in ... PFS rates at 12 months for DR vs non-DR pts were 60% and 51%; and in the ER vs non-ER pts were 51% vs 58%. Conclusions: The novel, chemotherapy ...

6. withpower.com withpower.com/trial/cc-122-for-non-hodgkins-lymphoma-68d12

CC-122 for Non-Hodgkin's Lymphoma · Info for Participants The safety of new drugs for lymphoid malignancies, like CC-122, requires careful attention due to potential adverse events and drug interactions. While newer ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT01421524/study-of-cc-122-to-evaluate-the-safety-tolerability-and-effectiveness-for-patients-with-advanced-solid-tumors-non-hodgkins-lymphoma-or-multiple-myeloma?activelyRecruiting=false&page=229&id=841&slug=bone-neoplasm

Study of CC-122 to Evaluate the Safety, Tolerability, and ... The main purpose of this first in human study with CC-122 is to assess the safety and action of a new class of experimental drug ...