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Anti-Angiogenesis Agent
Combination Therapy for B-Cell Lymphoma
Phase 2
Recruiting
Led By Jason Westin, MD, MS, FACP
Research Sponsored by M.D. Anderson Cancer Center
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 through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial will test if a combo of drugs can help control relapsed/refractory FL and DLBCL.
Who is the study for?
Adults with relapsed B-cell non-Hodgkin lymphoma, including Follicular Lymphoma and diffuse large B-cell lymphoma, who have seen their disease progress after at least one prior treatment. Participants must be over 18, not pregnant or breastfeeding, willing to use contraception and join the Revlimid REMS program.Check my eligibility
What is being tested?
The trial is testing a combination of four drugs: Mosunetuzumab, Polatuzumab vedotin, Tafasitamab, and Lenalidomide in patients whose B-cell NHL has returned after previous treatments. It aims to see if this drug combo can better control the disease.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion of the drugs such as fever or chills; low blood cell counts leading to increased infection risk; tiredness; liver issues indicated by abnormal blood tests; nerve damage causing numbness or tingling.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Heart rate
Trial Design
2Treatment groups
Experimental Treatment
Group I: Safety Run InExperimental Treatment4 Interventions
During the safety run-in, the study team will first test a recommended dose of mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide.
Group II: Dose Expansion CohortExperimental Treatment4 Interventions
Participants will receive mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide at the dose level that was found tolerated in the safety run-in.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tafasitamab
2016
Completed Phase 2
~180
Lenalidomide
2005
Completed Phase 3
~1480
Mosunetuzumab
2019
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,310 Total Patients Enrolled
Jason Westin, MD, MS, FACPPrincipal InvestigatorM.D. Anderson Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe nerve pain or damage.I have not received any live vaccines in the last 28 days.My lymphoma has spread to my brain or spinal cord.I have not had a stroke or brain bleed in the last 6 months.I have had a solid organ transplant.I have been diagnosed with a type of lymphoma called CD20+ Follicular Lymphoma grades 1-3a.I have not had any infections in the last 2 weeks.I haven't had cancer in the last 2 years, except for certain skin cancers or low-grade cervical cancer.I currently have a blood clot in my lungs or deep veins.I have been treated with polatuzumab vedotin before.I have not had CAR-T therapy in the last 30 days.I am eligible for a stem cell transplant using my own cells for my relapsed or refractory diffuse large B-cell lymphoma.I have had a stem cell transplant from a donor.I might have active or latent tuberculosis.My blood counts are within a healthy range.I am allergic or cannot take certain medications needed for the trial.I am 18 years old or older.I have previously been treated with tafasitamab and/or lenalidomide.I do not have any serious health issues that would make it unsafe for me to join.I haven't had chemotherapy, immunotherapy, or other cancer treatments in the last 4 weeks.I have uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia.I agree to use contraception for 3 months after my last treatment if I am not surgically sterile.I am willing to receive blood transfusions.I can take aspirin daily without any issues.I have relapsed CD20+ diffuse large B-cell lymphoma.I am HIV positive.I have a bleeding disorder or am currently experiencing active bleeding.I have previously been treated with mosunetuzumab or similar medications.I have relapsed CD20+ diffuse large B-cell lymphoma.I have not had radiotherapy in the last 2 weeks.I am a woman who can have children and have a recent negative pregnancy test.I have or might have had a condition where my immune system attacks my body.I have not had major surgery in the last 4 weeks.I had a stem cell transplant using my own cells less than 100 days ago.I have been taking corticosteroids regularly for the last 2 weeks.My condition did not improve after at least one treatment.I am registered and agree to follow the Revlimid REMS program requirements.I have a lymph node larger than 1.5cm.
Research Study Groups:
This trial has the following groups:- Group 1: Safety Run In
- Group 2: Dose Expansion Cohort
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.
Are researchers still seeking participants for this trial?
"Per the information found on clinicaltrials.gov, this particular medical study is no longer recruiting patients; the initial posting was made on April 30th 2023 and it has not been updated since November 7th 2022. Conversely, there are 1,728 other trials actively seeking candidates at present."
Answered by AI
What measures are taken to ensure the security of persons taking part in Safety Run In?
"Due to the fact this is a Phase 2 trial with data that supports safety but not efficacy, Power rated Safety Run In as having an elevated level of risk (2)."
Answered by AI
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