36 Participants Needed

Obinutuzumab + CC-99282 for Follicular Lymphoma

DC
Overseen ByDai Chihara, M D, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on strong CYP3A inhibitors, you must stop them and wait for a 7-day washout period (time without taking certain medications) or 5 half-lives, whichever is longer, before starting the trial.

What data supports the effectiveness of the drug Obinutuzumab + CC-99282 for Follicular Lymphoma?

Obinutuzumab has shown effectiveness in treating follicular lymphoma, especially in patients who did not respond to or relapsed after rituximab treatment, by significantly prolonging progression-free survival when combined with bendamustine. This suggests potential effectiveness when combined with other treatments like CC-99282.12345

What makes the drug Obinutuzumab + CC-99282 unique for treating follicular lymphoma?

Obinutuzumab is a new type of anti-CD20 antibody that is engineered to enhance its ability to kill cancer cells, making it potentially more effective than the current standard, rituximab, especially for patients who have not responded to or have relapsed after rituximab treatment. This combination with CC-99282, a novel treatment, could offer a new option for patients with follicular lymphoma, particularly those who have limited responses to existing therapies.12367

What is the purpose of this trial?

This trial is testing a combination of two drugs, obinutuzumab and CC-99282, to treat patients with untreated, high tumor burden follicular lymphoma. Obinutuzumab helps the immune system identify cancer cells, while CC-99282 enhances the immune response to destroy these cells. The goal is to see if this combination can effectively control the cancer and improve patient outcomes.

Research Team

Dai Chihara | MD Anderson Cancer Center

Dai Chihara, M D

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with previously untreated, high tumor burden follicular lymphoma. Participants must have certain blood count levels, no prior cancer treatments, and be in a specific disease stage. They should not be pregnant or breastfeeding and must agree to contraception measures.

Inclusion Criteria

My condition is at stage II, III, or IV.
I can take care of myself but might not be able to do heavy physical work.
I have a tumor larger than 7 cm outside of my spleen.
See 37 more

Exclusion Criteria

I have had cancer other than B-NHL but have been free of it for over 3 years.
I do not have any severe illnesses that could affect my safety or the study's results.
I do not have serious heart problems or recent heart attacks.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive obinutuzumab and CC-99282 for up to 6 cycles, each cycle lasting 28 days

24 weeks

Extended Treatment

Participants may continue to receive obinutuzumab and CC-99282 for Cycles 7-12 based on disease status

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 months

Treatment Details

Interventions

  • CC-99282
  • Obinutuzumab
Trial Overview The study tests the effectiveness of obinutuzumab combined with CC-99282 in controlling high tumor burden follicular lymphoma that hasn't been treated before. It's a Phase 2 trial focusing on these two drugs' impact on this type of lymphoma.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Obinutuzumab+CC-99282Experimental Treatment2 Interventions
Participants will receive obinutuzumab and CC-99282 together for up to 12 study cycles. Each study cycle is 28 days. Participants will first receive the study drugs for Cycles 1-6. Then after participants complete Cycle 6, the study doctor will decide based on the status of the disease if participant will continue to receive the study drugs for Cycles 7-12 or if participant will stop receiving them.

CC-99282 is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Epkinly for:
  • Diffuse large B-cell lymphoma
  • High-grade B-cell lymphoma
  • Follicular lymphoma
🇪🇺
Approved in European Union as Tepkinly for:
  • Diffuse large B-cell lymphoma
  • High-grade B-cell lymphoma
  • Follicular lymphoma
🇨🇦
Approved in Canada as Epkinly/Tepkinly for:
  • Diffuse large B-cell lymphoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Bristol-Myers Squibb

Industry 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 profile image

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 profile image

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

Obinutuzumab, combined with bendamustine, significantly prolonged progression-free survival (PFS) in patients with indolent non-Hodgkin's lymphoma, particularly benefiting those with follicular lymphoma, as shown in the phase III GADOLIN study.
The treatment was generally well-tolerated, with mild to moderate infusion-related reactions being the most common side effects, while neutropenia was the most frequent severe adverse event, indicating a manageable safety profile.
Obinutuzumab: A Review in Rituximab-Refractory or -Relapsed Follicular Lymphoma.Dhillon, S.[2018]
Obinutuzumab, a novel CD20 antibody, demonstrated superior anti-tumor activity compared to rituximab in preclinical mouse models of non-Hodgkin lymphoma, particularly when combined with chemotherapy agents like bendamustine.
In these studies, obinutuzumab alone was at least as effective as rituximab combined with chemotherapy, suggesting it could be a more effective treatment option for patients with non-Hodgkin lymphoma.
Enhanced anti-tumor activity of the glycoengineered type II CD20 antibody obinutuzumab (GA101) in combination with chemotherapy in xenograft models of human lymphoma.Herting, F., Friess, T., Bader, S., et al.[2021]
Obinutuzumab, a new anti-CD20 monoclonal antibody, has shown promising efficacy in treating follicular lymphoma (FL) and has been approved by the FDA for use in combination with bendamustine for patients who have relapsed after rituximab treatment.
Ongoing phase III trials, such as the GALLIUM trial, suggest that obinutuzumab may soon be established as a first-line treatment for FL, potentially replacing rituximab as the gold standard, although some safety concerns remain to be addressed.
Obinutuzumab in follicular lymphoma.Martinez-Calle, N., Figueroa-Mora, R., Villar-Fernandez, S., et al.[2017]

References

Obinutuzumab: A Review in Rituximab-Refractory or -Relapsed Follicular Lymphoma. [2018]
Enhanced anti-tumor activity of the glycoengineered type II CD20 antibody obinutuzumab (GA101) in combination with chemotherapy in xenograft models of human lymphoma. [2021]
Obinutuzumab in follicular lymphoma. [2017]
Noninvasive Evaluation of CD20 Expression Using 64Cu-Labeled F(ab')2 Fragments of Obinutuzumab in Lymphoma. [2021]
Combination of Atezolizumab and Obinutuzumab in Patients with Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-Cell Lymphoma: Results from a Phase 1b Study. [2022]
GA101 (a Novel Anti-CD20 Monoclonal Antibody)-Induced Lichenoid Eruption. [2022]
Obinutuzumab for the treatment of indolent lymphoma. [2018]
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