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Immunomodulatory agents
Mosunetuzumab + Lenalidomide for Follicular Lymphoma
Phase 1 & 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fluorodeoxyglucose avid lymphoma (i.e., positron emission tomography (PET) positive lymphoma)
At least one bi dimensionally measurable nodal lesion (>1.5 cm in its largest dimension by PET- computed tomography (CT) scan), or at least one bi dimensionally measurable extranodal lesion (>1.0 cm in its largest dimension by PET-CT scan)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at pre-defined intervals from baseline through follow-up (2 years after last treatment)
Awards & highlights
Study Summary
This trial is testing mosunetuzumab + lenalidomide as a possible treatment for relapsed or refractory follicular lymphoma. Researchers will also compare the safety, efficacy, and immunogenicity of mosunetuzumab + len given intravenously versus subcutaneously.
Who is the study for?
This trial is for adults with follicular lymphoma who've had at least one prior treatment. They must be in stable condition, not have severe allergies to monoclonal antibodies or certain infections, and agree to contraception if of childbearing potential. Those with a history of certain other cancers or conditions are excluded.Check my eligibility
What is being tested?
The study tests the combination of mosunetuzumab (given intravenously or subcutaneously) with lenalidomide in patients with follicular lymphoma. It aims to compare safety, how the body processes the drugs, and their effectiveness against this type of cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion such as fever and chills, low blood cell counts increasing infection risk, tiredness, rash or itching at injection site for SC administration, and possibly others depending on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymphoma shows up on PET scans.
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I have a tumor that can be measured by a PET-CT scan.
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My follicular lymphoma is Grade 1, 2, or 3a and CD20 positive.
Select...
I have follicular lymphoma and have been treated before with systemic therapy.
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I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at pre-defined intervals from baseline through follow-up (2 years after last treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at pre-defined intervals from baseline through follow-up (2 years after last treatment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cumulative Area under the Curve over Cycles 1-3 (AUC1-3) of Mosunetuzumab
Dose-Limiting Toxicities (DLTs)
Percentage of Participants with Adverse Events
+1 moreSecondary outcome measures
AUC at Steady State (AUCss) (Arms A and B)
Area Under the Concentration vs Time Curve (AUC) of Mosunetuzumab
CRR as determined by Independent Review Committee (IRC) (randomized stage)
+13 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Subcutaneous (SC) Mosunetuzumab + Lenalidomide (Non-randomized)Experimental Treatment2 Interventions
Participants will receive treatment with SC mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward). Participants that have received complete metabolic response (CMR) or partial metabolic response (PMR) after 12 cycles of induction therapy with mosunetuzumab + lenalidomide will have the option of receiving maintenance therapy with SC mosunetuzumab every 8 weeks (Q8W) for an additional 9 cycles.
Group II: Intravenous (IV) Mosunetuzumab + Lenalidomide (Non-randomized)Experimental Treatment3 Interventions
Participants will receive treatment with IV mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward)
Group III: Arm B: SC Mosunetuzumab + Len (Randomized)Experimental Treatment2 Interventions
Participants will receive treatment with SC mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward)
Group IV: Arm A: IV Mosunetuzumab + Len (Randomized)Experimental Treatment2 Interventions
Participants will receive treatment with IV mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Tocilizumab
2012
Completed Phase 4
~1840
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,429 Previous Clinical Trials
1,089,215 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,315 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a significant history of liver problems.You have a history of using illegal drugs or abusing alcohol in the past year, according to the doctor's assessment.I experience significant numbness or pain in my hands or feet.My condition did not improve after 6 months of lenalidomide treatment.My lymphoma shows up on PET scans.I haven't had major surgery in the last 28 days and don't expect any during the study.I cannot take blood clot prevention medications.I have received cancer treatment as outlined in the study.I have a history of DLBCL or my condition has changed into DLBCL.I haven't had a major infection or needed IV antibiotics in the last 4 weeks.I have active Hepatitis B or C, or an autoimmune disease needing treatment.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.My condition did not improve after treatment with obinutuzumab alone.I do not have any major health issues that could interfere with the study.I've had severe skin reactions or blisters from past immune therapy.I have had a stem cell transplant from a donor.I do not have any other cancer that could interfere with this study.My blood counts are within normal ranges, unless affected by my lymphoma.I have untreated follicular lymphoma and need systemic therapy as per GELF criteria.I have a history of Grade 3b follicular lymphoma.I haven't taken any immune-weakening medications in the last 2 weeks.I am HIV positive.I have or might have a chronic Epstein-Barr virus infection or hemophagocytic syndrome.I have had progressive multifocal leukoencephalopathy.I have a tumor that can be measured by a PET-CT scan.You are allergic to products derived from mice.You are allergic to medications made from Chinese hamster ovary cells or any ingredient in the study drugs glofitamab, Mosun, G, Len, or thalidomide, including mannitol.My blood counts are too low.I have or had brain lymphoma or cancer spread to the lining of my brain and spinal cord.You are expected to live for less than three months.I agree to use birth control or remain abstinent and not donate sperm while on treatment and for a specified time after.I have a history of specific lung conditions or signs of lung inflammation on a CT scan.I tested negative for HIV or I am stable on HIV treatment with no recent severe infections.My blood tests are normal, except for issues caused by my lymphoma.My follicular lymphoma is Grade 1, 2, or 3a and CD20 positive.I have a history of MAS or HLH.Any severe side effects from my past treatments have improved.You have had a serious allergic reaction to certain types of medication called monoclonal antibodies.I have follicular lymphoma and have been treated before with systemic therapy.I have had a solid organ transplant.I have had a stem cell transplant from a donor.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Subcutaneous (SC) Mosunetuzumab + Lenalidomide (Non-randomized)
- Group 2: Intravenous (IV) Mosunetuzumab + Lenalidomide (Non-randomized)
- Group 3: Arm B: SC Mosunetuzumab + Len (Randomized)
- Group 4: Arm A: IV Mosunetuzumab + Len (Randomized)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is this experiment looking to recruit?
"Affirmative. According to medical data on clinicaltrials.gov, this study is currently recruiting participants; it was initially posted in August 2020 and updated lastly in November 2022. In total, 169 individuals are required across one centre of care."
Answered by AI
What conditions is Mosunetuzumab (IV) typically prescribed to address?
"Mosunetuzumab (IV) is a commonly prescribed treatment for patients who have already undergone two different chemotherapy regimens. It can also help alleviate symptoms of systemic juvenile idiopathic arthritis, amyloidosis, and muscular dystrophy."
Answered by AI
What other tests have been conducted using Mosunetuzumab (IV) as the primary agent?
"Currently, there are 424 clinical trials investigating Mosunetuzumab (IV); 81 of which are at the advanced Phase 3. Most studies regarding this treatment take place in Chicago, Illinois; though 19295 other medical centres across the world also research it."
Answered by AI
Is participation in this investigation available to volunteers at the present time?
"Affirmative. According to data hosted on clinicaltrials.gov, this research initiative is still recruiting participants after having been posted on August 12th 2020 and last updated November 16th 2022 --- 169 individuals are being sought from one single medical site."
Answered by AI
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