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Immunomodulatory Agents
Mosunetuzumab + Lenalidomide vs Rituximab for Follicular Lymphoma (Celestimo Trial)
Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically documented CD20+ FL (Grades 1-3a)
Received at least one prior systemic lymphoma therapy, which included prior immunotherapy or chemoimmunotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 8 years
Awards & highlights
Celestimo Trial Summary
This trial will compare two treatments for people with a certain type of blood cancer who have tried other treatments unsuccessfully.
Who is the study for?
This trial is for adults with relapsed or refractory follicular lymphoma who have had at least one prior systemic therapy. They must be in a condition to receive treatment, not have grade 3b FL or transformed indolent disease, and no recent exposure to certain cancer therapies. Participants need adequate organ function and cannot be pregnant, breastfeeding, or planning pregnancy; they must agree to contraception measures.Check my eligibility
What is being tested?
The study compares the effectiveness of mosunetuzumab combined with lenalidomide versus rituximab combined with lenalidomide in treating follicular lymphoma. It will assess which combination works better for those who've already tried other treatments.See study design
What are the potential side effects?
Potential side effects include allergic reactions to monoclonal antibodies, infusion-related reactions, blood disorders, increased risk of infections due to immunosuppression from medications like tocilizumab and lenalidomide. Organ-specific inflammation may also occur.
Celestimo Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymphoma is CD20 positive and is grade 1-3a.
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I have had treatment for lymphoma that included immunotherapy or chemoimmunotherapy.
Select...
I can provide a biopsy sample or have one from my latest relapse for my FL diagnosis.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Celestimo Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 8 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) according to 2014 Lugano Response Criteria
Secondary outcome measures
Area Under the Curve (AUC) of M + Len
Complete Response Rate
Duration of Complete Reponse (DOCR)
+10 moreCelestimo Trial Design
3Treatment groups
Experimental Treatment
Group I: R + Len (Arm B)Experimental Treatment3 Interventions
Participants will receive weekly rituximab in Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11. Participants will also receive lenalidomide in Cycles 1-12. (Cycle length = 28 days for Cycles 1-12)
Group II: M + Len (US Extension Arm C)Experimental Treatment3 Interventions
Participants will receive mosunetuzumab for 12 cycles, plus lenalidomide from cycles 2-12 (Cycle length = 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12)
Group III: M + Len (Arm A)Experimental Treatment3 Interventions
Participants will receive mosunetuzumab for 12 cycles, plus lenalidomide from cycles 2-12 (Cycle length = 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mosunetuzumab
2019
Completed Phase 2
~140
Lenalidomide
2005
Completed Phase 3
~1480
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,749 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,466 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a solid organ transplant.I have or had brain lymphoma or cancer spread to the lining of my brain and spinal cord.I have or might have a long-term active Epstein-Barr virus infection.My lymphoma is CD20 positive and is grade 1-3a.I have or might have had a condition where my immune system attacks my body.My slow-growing lymphoma has changed into an aggressive type.I have had a stem cell transplant from a donor.I am allergic to certain medications made in specific lab cells or their ingredients.My condition did not improve or worsened within 6 months after taking lenalidomide.I agree to use effective birth control or remain abstinent during and after treatment.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I have a history of lung conditions like interstitial lung disease or pneumonitis.I have never had progressive multifocal leukoencephalopathy.My doctor says I need treatment for my tumor based on its size or specific criteria.I have had treatment for lymphoma that included immunotherapy or chemoimmunotherapy.I haven't had major surgery in the last 28 days and don't expect any during the study.I can provide a biopsy sample or have one from my latest relapse for my FL diagnosis.I have an active Hepatitis C infection.I agree to use birth control or abstain from sex and not donate sperm while on treatment and for some time after.You have had a serious allergic reaction in the past to certain types of medications called monoclonal antibodies.I don't have major side effects from previous treatments, except for hair loss.I've had severe skin reactions or blisters from past immune therapy.You are allergic to substances derived from mice.I do not have any major health issues that could interfere with the study.I have a history of autoimmune disease.I have an active Hepatitis B infection.I am HIV positive.I do not have any other cancer that could interfere with this study.I haven't taken strong immune system suppressing drugs in the last 2 weeks.I haven't had a major infection or needed IV antibiotics in the last 4 weeks.I cannot take blood clot prevention medications due to health reasons.My blood counts are within normal ranges, unless affected by my lymphoma.I haven't had certain cancer treatments recently.I am currently being treated for an autoimmune disease.I have a significant history of liver disease.I can take care of myself and am up and about more than half of my waking hours.My condition is Grade 3b Follicular Lymphoma.
Research Study Groups:
This trial has the following groups:- Group 1: M + Len (Arm A)
- Group 2: R + Len (Arm B)
- Group 3: M + Len (US Extension Arm C)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has Mosunetuzumab gone through the necessary steps for public consumption?
"There is evidence from previous trials to support the efficacy of Mosunetuzumab, as well as data attesting to its safety. Consequently, we have rated it a 3 on our safety scale."
Answered by AI
For what purpose is Mosunetuzumab most commonly employed?
"Mosunetuzumab is a medication that can be prescribed to diffuse large b-cell lymphoma (dlbcl) patients. Additionally, it is approved for use in treating b-cell lymphomas and polyangium when the patient has already tried two other systemic chemotherapy regimens."
Answered by AI
Are there other ongoing research studies that are testing Mosunetuzumab?
"Mosunetuzumab was first studied in 1993 at the National Institutes of Health Clinical Center. Since then, there have been 1103 completed studies and 637 active trials. A large number of these trials are being performed out of Durham, North carolina."
Answered by AI
In how many different clinics is this research being conducted?
"There are a total of 14 sites where this study is currently being conducted. These locations include the Duke University Medical Center in Durham, the Fort Wayne Medical Institute in Fort Wayne, and the Winship Cancer Institute in Atlanta, among others."
Answered by AI
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