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Monoclonal Antibodies
Immunotherapy for Hodgkin's Lymphoma
Phase 2
Recruiting
Led By Dai Chihara
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to 5 years
Awards & highlights
Study Summary
This trial compares mosunetuzumab to rituximab to see if mosunetuzumab can help extend survival in patients with NLPHL. Monoclonal antibodies bind to proteins on cancer cells, which may help the immune system kill them.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
As both treatments involve monoclonal antibodies that target immune responses, potential side effects may include infusion reactions, fatigue, allergic reactions, and an increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS) time
Secondary outcome measures
Duration of response
Objective response
Overall survival (OS)
Other outcome measures
CD20 expression
Dynamic molecular response of nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) patients
Fludeoxyglucose F-18 positron emission tomography/computed tomography (FDG-PET/CT) measurements
+3 moreTrial Design
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 end of treatment, and blood sample collection throughout the trial.
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 end of treatment, and blood sample collection throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mosunetuzumab
2019
Completed Phase 2
~140
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,669 Previous Clinical Trials
40,926,331 Total Patients Enrolled
Dai ChiharaPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO
Raphael E SteinerPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO
2 Previous Clinical Trials
190 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still enrollments available for this clinical trial?
"This research study, which was published on July 27th 2024 and revised November 14th 2023, is currently recruiting participants according to clinicaltrials.gov."
Answered by AI
To what extent does the use of Mosunetuzumab pose a risk to patients?
"For Mosunetuzumab, there is preliminary evidence of safety but no proof yet of efficacy. Therefore, its score was set at 2 on the 1 to 3 scale created by our team at Power."
Answered by AI
What is the patient sample size for this investigation?
"Affirmative. In accordance with the information shared on clinicaltrials.gov, this research is recruiting clinicians and their patients from July 27th 2024 onward. As of November 14th 2023, 70 participants are needed to be sourced across 1 site."
Answered by AI
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