70 Participants Needed

Immunotherapy for Hodgkin's Lymphoma

Recruiting at 34 trial locations
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 protocol does not specify if you need to stop taking your current medications. However, you cannot be on systemic immunosuppressive medications within 2 weeks before starting the study treatment.

What data supports the effectiveness of the drug Rituximab for treating Hodgkin's Lymphoma?

Rituximab has shown effectiveness in treating certain types of non-Hodgkin's lymphoma and has been used in combination with other treatments for relapsed and refractory Hodgkin lymphoma, suggesting potential benefits in similar conditions.12345

What safety information is available for immunotherapy treatments like Rituximab and similar drugs?

Rituximab, a type of immunotherapy, has been used for over 10 years and is generally safe, but it can increase the risk of infections, especially in people with weakened immune systems. Common side effects of monoclonal antibodies like Rituximab include flu-like symptoms during the first infusion, and there is a risk of serious infections like hepatitis B reactivation and a rare brain infection called PML.678910

How is the drug Mosunetuzumab, Rituximab unique for treating Hodgkin's Lymphoma?

Mosunetuzumab is a novel drug that works by engaging the body's immune system to target and destroy cancer cells, while Rituximab is a well-established antibody that targets a specific protein on B cells. This combination may offer a new approach for treating Hodgkin's Lymphoma by potentially enhancing the immune response against the cancer.15111213

What is the purpose of this trial?

This trial is testing a new treatment called mosunetuzumab against the usual treatment, rituximab, for patients with a type of cancer called NLPHL. Both treatments help the immune system find and kill cancer cells by targeting a specific protein on these cells. The goal is to see if mosunetuzumab can improve survival better than rituximab.

Research Team

Dr. Raphael E. Steiner, MD | Uniondale ...

Raphael Steiner, MD

Principal Investigator

University of Texas MD Anderson Cancer Center LAO

Eligibility Criteria

This trial is for adults with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL), either untreated or previously treated but not within the last 6 months if rituximab was used. Participants need to have symptoms like fever, weight loss, night sweats, or measurable disease and can't just be observed. They must also have good organ function and performance status.

Inclusion Criteria

Patients must have measurable disease according to the Lugano/LYRIC classification
Agreement to use adequate contraception by women of childbearing potential and men
Ability to understand and sign a written informed consent document
See 15 more

Exclusion Criteria

Uncontrolled intercurrent illness or significant conditions making participation hazardous
I have or might have a long-term EBV or CMV infection.
I have not had infections needing IV treatment in the last 4 weeks.
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either mosunetuzumab or rituximab. Mosunetuzumab is administered subcutaneously on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles, repeating every 21 days for up to 8 cycles. Rituximab is administered intravenously on day 1 and with hyaluronidase human subcutaneously on days 8, 15, and 22 of each cycle, repeating every 28 days for up to 2 cycles.

8-16 weeks
Multiple visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 6 months for 2 years.

2 years
Follow-up visits every 6 months

Crossover

Participants experiencing disease progression may crossover to the alternate treatment arm at week 12.

Until disease progression or unacceptable toxicity

Treatment Details

Interventions

  • Mosunetuzumab
  • Rituximab
Trial Overview The study compares mosunetuzumab with the usual treatment of rituximab in improving survival for NLPHL patients. Both drugs are monoclonal antibodies targeting CD20 on B cells and cancer cells, potentially helping the immune system destroy these cells.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (Mosunetuzumab)Experimental Treatment7 Interventions
Patients receive mosunetuzumab SC on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients who experience PD will be permitted to crossover to arm II at week 12. Patients also receive FDG and undergo PET/CT at baseline and end of treatment. Patients who are positive at pre-treatment bone marrow biopsy also receive FDG and undergo PET/CT on study. Patients also undergo bone marrow biopsy and tissue biopsy at baseline, and blood sample collection throughout the trial. Patients may also undergo bone marrow biopsy and tissue biopsy at end of treatment.
Group II: Arm II (Rituximab, Rituximab and hyaluronidase human)Active Control8 Interventions
Patients receive rituximab IV on day 1 and rituximab and hyaluronidase human SC on days 8, 15, and 22 of each cycle. Cycles repeat every 28 days for up to 2 cycles 8 weeks apart in the absence of disease progression or unacceptable toxicity. Patients may receive rituximab IV on days 8, 15, and 22 of each cycle if rituximab and hyaluronidase human is not available. Patients who experience PD will be permitted to crossover to arm I at week 12. Patients also receive FDG and undergo PET/CT at baseline and end of treatment. Patients who are positive at pre-treatment bone marrow biopsy also receive FDG and undergo PET/CT on study. Patients also undergo bone marrow biopsy and tissue biopsy at baseline, and blood sample collection throughout the trial. Patients may also undergo bone marrow biopsy and tissue biopsy at end of treatment.

Mosunetuzumab is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Lunsumio for:
  • Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
🇺🇸
Approved in United States as Lunsumio for:
  • Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Findings from Research

A 45-year-old woman with a history of Hodgkin's disease transformed into high-grade non-Hodgkin's lymphoma was successfully treated with Rituximab, a CD20 antibody, achieving complete remission 14 months later.
This case suggests that Rituximab can be an effective immunotherapy option for patients with chemotherapy-resistant cases of lymphoma, highlighting its potential in treating related lymphomas due to the clonal relationship between Hodgkin's disease and non-Hodgkin's lymphoma.
Transformation of Hodgkin's disease to high-grade B-cell lymphoma: remission after Rituximab monotherapy.Kirchner, EM., Ebsen, M., Kirchner, J., et al.[2020]
In a study of 7 patients with relapsed and refractory Hodgkin lymphoma, Rituximab combined with second-line chemotherapy regimens led to a complete remission in 4 patients, demonstrating its efficacy as a treatment option.
The two-year survival rate was 85.7%, although the treatment was associated with significant side effects, particularly bone marrow suppression.
[Rituximab combined with second line regimens for treatment of seven relapsed and refractory Hodgkin lymphoma patients].Liu, H., Li, H., Xiong, W., et al.[2020]
Rituximab, a chimeric anti-CD20 monoclonal antibody, has shown to induce responses in nearly 50% of patients with relapsed follicular/low-grade non-Hodgkin's lymphoma, with complete remissions occurring in 6% of cases, highlighting its efficacy in treating this type of cancer.
The drug is generally well tolerated, with common side effects being mild to moderate fevers and chills, and it is also effective against various other B-cell malignancies, suggesting its potential for broader applications in both cancer treatment and autoimmune disorders.
Rituximab: clinical development and future directions.Cheson, BD.[2019]

References

Transformation of Hodgkin's disease to high-grade B-cell lymphoma: remission after Rituximab monotherapy. [2020]
[Rituximab combined with second line regimens for treatment of seven relapsed and refractory Hodgkin lymphoma patients]. [2020]
Rituximab: clinical development and future directions. [2019]
Rituximab: review and clinical applications focusing on non-Hodgkin's lymphoma. [2015]
Treatment with ibritumomab tiuxetan radioimmunotherapy in patients with rituximab-refractory follicular non-Hodgkin's lymphoma. [2022]
Pharmaceutical follow-up for patients on rituximab therapy for non-Hodgkin lymphoma: what is the evidence? [2021]
[Toxicity of targeted therapies and immunotherapy with checkpointinhibitors in Hodgkin lymphoma]. [2023]
Unique aspects of supportive care using monoclonal antibodies in cancer treatment. [2020]
Post-marketing safety of antineoplasic monoclonal antibodies: rituximab and trastuzumab. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
Rituximab-associated infections. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Use of rituximab, the new FDA-approved antibody. [2019]
Rituximab and its role as maintenance therapy in non-Hodgkin lymphoma. [2015]
[Role of anti-CD20 monoclonal antibody in association with immunomodulatory agents]. [2017]
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