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Monoclonal Antibodies
Tafasitamab + Rituximab for Lymphoma
Phase 2
Recruiting
Led By Timothy J Voorhees, MD, MSCR
Research Sponsored by Timothy Voorhees
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological evidence of B-cell PTLD (monomorphic and polymorphic) following solid organ transplantation; expresses CD19 and CD20, with or without EBV association, confirmed after biopsy or resection of tumor
Subjects having undergone heart, lung, liver, kidney, pancreas, small intestine transplantation or a combination of the organ transplantations mentioned
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial tests 2 drugs to treat lymphoma in transplant patients to see if they work better than current treatments.
Who is the study for?
Adults who've had an organ transplant and developed a type of lymphoma called post-transplant lymphoproliferative disorder (PTLD) are eligible. They should have measurable disease, acceptable organ function tests, no prior PTLD therapy except for certain treatments like antivirals or steroids, and not be pregnant or breastfeeding. People with HIV can join if it's under control.Check my eligibility
What is being tested?
The trial is testing the effectiveness of two monoclonal antibodies, tafasitamab and rituximab, in treating PTLD. These drugs help the immune system target and kill cancer cells. Participants will receive injections of these medications to see if they work better together as a first-line treatment.See study design
What are the potential side effects?
Potential side effects include infusion reactions such as fever or chills, weakness, infections due to lowered immunity, liver problems signaled by yellowing skin or eyes (jaundice), nausea or vomiting. Each person may experience side effects differently.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is a type of B-cell disorder after an organ transplant and tests positive for CD19 and CD20.
Select...
I have had an organ transplant (heart, lung, liver, kidney, pancreas, or small intestine).
Select...
My cancer can be measured and is larger than 1.5 cm or is in my bone marrow.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of patients who achieve a complete response (CR)
Secondary outcome measures
Best overall response
Incidence of adverse events
Overall response rate
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (tafasitamab, rituximab)Experimental Treatment6 Interventions
Patients receive tafasitamab IV and rituximab IV or SC on study. Patients who have CR or PR after 4 cycles may receive additional tafasitamab and rituximab on study. Patients also undergo PET or CT, biopsy, and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2210
Rituximab
1999
Completed Phase 4
~1880
Tafasitamab
2016
Completed Phase 2
~180
Find a Location
Who is running the clinical trial?
Timothy VoorheesLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Timothy J Voorhees, MD, MSCRPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had progressive multifocal leukoencephalopathy in the past.You have given written agreement to partake in the study, and have authorized access of your healthcare information under HIPAA regulations.My kidney function, measured by creatinine clearance, is adequate.I have another cancer, but it won't affect this trial's treatment.I haven't received treatment for PTLD, but palliative care or medication adjustments are okay.My tumor is a type of B-cell disorder after an organ transplant and tests positive for CD19 and CD20.I have active hepatitis B but am on entecavir or have an undetectable viral load.You have a medical condition or laboratory results that make it unsafe for you to participate in this study or could make it difficult to understand the study results.Your platelet count is at least 50 x 10^9/L within two weeks prior to beginning the study.I do not have any severe uncontrolled illnesses like heart failure, unstable heart conditions, recent heart attacks, uncontrolled seizures, or very high blood pressure.My condition involves the brain or spinal cord.AST (aspartate aminotransferase) levels must be at or below 3.0 times the upper limit of normal, obtained within 14 days before starting study treatment.Your Alanine aminotransferase (ALT) level is below 3.0 times the upper limit of normal within 14 days prior to beginning study treatment.I have HIV with an undetectable viral load and a CD4+ count over 200.I am not pregnant and can prove I am unable to have children or am postmenopausal.I agree to use two effective birth control methods if I can have children.I have been treated for PTLD, but only with radiation, antivirals, steroids, or by lowering my immune system's activity.I am a male and will use effective birth control during and for 12 months after the study.I have had an organ transplant (heart, lung, liver, kidney, pancreas, or small intestine).I am willing and able to follow the study's requirements.I can care for myself but may not be able to do any physical work.My cancer can be measured and is larger than 1.5 cm or is in my bone marrow.I developed a lymph disorder after a blood or marrow transplant.Your total bilirubin must not exceed 3.0 mg/dL, and your conjugated bilirubin should be no greater than 3.0 x ULN (as measured within 14 days of the start of the study)I have not received any live vaccines in the last 28 days.I am 18 years old or older.You have a projected life expectancy exceeding 30 days.Your absolute neutrophil count must be at least 1.0 x 10^9/L, as measured within the preceding two-week period prior to commencing treatment.I do not have an uncontrolled infection or it is being effectively treated.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tafasitamab, rituximab)
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 there any unfilled positions for participants in this research?
"According to records on clinicaltrials.gov, this research endeavour is no longer recruiting participants; the trial was first posted May 1st 2023 and last updated March 23rd 2023. Despite that, there are still 998 other medical trials actively seeking patients at present time."
Answered by AI
Is the combination of tafasitamab and rituximab safe for patients to use?
"Taking into account the lack of efficacy data, our team assessed Treatment (tafasitamab, rituximab) as a 2 on their safety scale given that it is in Phase 2."
Answered by AI
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