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Immunomodulatory agents
Tafasitamab + Lenalidomide for Mantle Cell Lymphoma
Phase 2
Recruiting
Led By Anita Kumar, MD
Research Sponsored by Memorial Sloan Kettering 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 completion of 12 cycles of treatment (each cycle is 28 days) or at treatment discontinuation, whichever comes first
Awards & highlights
Study Summary
This trial seeks to find out if a combo of drugs can help treat a type of blood cancer.
Who is the study for?
Adults with relapsed or refractory Mantle Cell Lymphoma who've had at least one prior treatment including a BTKi, and can become pregnant must follow strict contraception guidelines. Participants need to have adequate organ function, no concurrent cancers requiring active therapy (with some exceptions), no significant infections or liver disease, and not be pregnant.Check my eligibility
What is being tested?
The study is testing the effectiveness of combining two drugs, Tafasitamab and Lenalidomide, for treating Mantle Cell Lymphoma that has returned after treatment or did not respond to previous treatments. The trial requires participants to undergo various assessments like bone marrow biopsy and imaging studies.See study design
What are the potential side effects?
Potential side effects include blood clots which require prophylaxis, increased risk of infection due to lowered immune defenses, possible liver issues indicated by elevated enzyme levels in tests, fatigue from anemia if platelet counts are low, and digestive disturbances.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completion of 12 cycles of treatment (each cycle is 28 days) or at treatment discontinuation, whichever comes first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of 12 cycles of treatment (each cycle is 28 days) or at treatment discontinuation, whichever comes first
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate/ORR
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants with Mantle Cell LymphomaExperimental Treatment2 Interventions
Participants have a diagnosis of Mantle Cell Lymphoma have previously failed or could not tolerate Bruton's tyrosine kinase inhibitors/BTKi
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
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,816 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,126 Total Patients Enrolled
Anita Kumar, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
764 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a significant history of liver disease.I have not received a live vaccine in the last 28 days.I have lymphoma in my brain or spinal cord.I am willing to take treatment to prevent blood clots.I have Hepatitis B or C and need antiviral treatment.I have not taken Lenalidomide in the last 12 months.I do not have any severe illnesses that could risk my safety or affect the study's results.My condition did not improve with lenalidomide treatment.My cancer has been tested and shows CD19 presence.I do not have any active infections when joining the study.I have taken corticosteroids for 10 days or less and stopped before starting this study.I stopped my chemotherapy at least 2 weeks ago.I haven't had any cancer treatments in the last 3 years, except for certain exceptions.I had a stem cell transplant using my own cells less than 3 months ago.All my side effects from previous treatments are mild or gone, except for hair loss.I am willing to undergo additional tests for my disease as required.I am able to care for myself but may not be able to do active work.My condition is relapsed or refractory mantle cell lymphoma.I have been treated for mantle cell lymphoma with a BTK inhibitor.I am 18 years old or older.My cancer can be measured or observed.I still feel sick from my last cancer treatment.I stopped any cancer-targeting treatments before starting this study.My organs and bone marrow are working well.I had a stem cell transplant from a donor within the last 3 months and am either experiencing GVHD or am on treatment for it.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical trial accepting participants at the present moment?
"Affirmative. According to clinicaltrials.gov, this experiment is currently looking for participants who it first posted on March 14th 2023 and most recently updated on the 27th of that same month. 39 individuals are needed across 7 different research sites."
Answered by AI
How perilous is the prognosis for people diagnosed with Mantle Cell Lymphoma?
"Judging from the Phase 2 trial, there is ample evidence that participants with Mantle cell lymphoma are safe when taking this medication; thus, it has been given a score of two."
Answered by AI
What are the number of medical facilities that have been authorized to undertake this clinical trial across the state?
"Patients for this trial can be enrolled in one of 7 different healthcare facilities, including the Memorial Sloan Kettering Monmouth (All protocol activities) located in Middletown and the Memorial Sloan Kettering Bergen (All protocol activities) at Montvale. Additionally, there are 4 other medical centres offering enrollment opportunities."
Answered by AI
What is the aggregate enrollment of this experiment?
"Affirmative. According to clinicaltrials.gov, the medical experiment was initially posted on March 14th 2023 and recently modified on March 27th 2023. It is currently searching for 39 volunteers from 7 different sites of participation."
Answered by AI
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