Obinutuzumab-Based Therapy for Follicular Lymphoma
Trial Summary
What is the purpose of this trial?
This phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Chemotherapy drugs, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy will work better in treating patients with grade I-IIIa follicular lymphoma.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on certain HIV medications or have had prior treatment with PI3K inhibitors or lenalidomide, you may not be eligible. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Obinutuzumab-based therapy for follicular lymphoma?
Research shows that Obinutuzumab, when combined with bendamustine, significantly extends the time patients live without their disease getting worse compared to bendamustine alone. This combination also improved overall survival in patients with follicular lymphoma, making it a promising option for those who have not responded to or have relapsed after previous treatments.12345
How is the drug Obinutuzumab unique in treating follicular lymphoma?
Obinutuzumab is a new type of anti-CD20 antibody that is engineered to enhance the immune system's ability to kill cancer cells, making it potentially more effective than the current standard treatment, rituximab. It is used in combination with bendamustine for patients who have not responded to or have relapsed after rituximab treatment, and it has shown promising results in prolonging survival in these patients.12356
Research Team
Paul M Barr
Principal Investigator
SWOG Cancer Research Network
Eligibility Criteria
This trial is for adults with grade I-IIIa follicular lymphoma that has relapsed or is refractory. Eligible participants must have had only one prior chemotherapy regimen, be at least 18 years old, and have adequate organ function. They should not have CNS involvement by lymphoma or previous treatment with PI3K inhibitors or lenalidomide.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy for up to 12 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bendamustine Hydrochloride
- Cyclophosphamide
- Doxorubicin Hydrochloride
- Lenalidomide
- Obinutuzumab
- Prednisone
- Umbralisib
- Vincristine Sulfate
Obinutuzumab is already approved in United States, European Union for the following indications:
- Chronic Lymphocytic Leukemia (CLL)
- Follicular Lymphoma
- Chronic Lymphocytic Leukemia (CLL)
- Follicular Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor