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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
Creatinine clearance (mL/min) >= 30 mL/min (obtained within 14 days prior to initiating study treatment) - Cockcroft-Gault Equation
Subjects with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the experimental regimen are eligible for the trial
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 below
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My kidney function, measured by creatinine clearance, is adequate.
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I have another cancer, but it won't affect this trial's treatment.
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I haven't received treatment for PTLD, but palliative care or medication adjustments are okay.
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My tumor is a type of B-cell disorder after an organ transplant and tests positive for CD19 and CD20.
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I have HIV with an undetectable viral load and a CD4+ count over 200.
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I am not pregnant and can prove I am unable to have children or am postmenopausal.
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I agree to use two effective birth control methods if I can have children.
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I am a male and will use effective birth control during and for 12 months after the study.
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I have had an organ transplant (heart, lung, liver, kidney, pancreas, or small intestine).
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I am willing and able to follow the study's requirements.
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I can care for myself but may not be able to do any physical work.
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My cancer can be measured and is larger than 1.5 cm or is in my bone marrow.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

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 more

Trial 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
~840
Biospecimen Collection
2004
Completed Phase 2
~1920
Computed Tomography
2017
Completed Phase 2
~2790
Positron Emission Tomography
2008
Completed Phase 2
~2260
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

Rituximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05786040 — Phase 2
Lymphoproliferative Disorder Research Study Groups: Treatment (tafasitamab, rituximab)
Lymphoproliferative Disorder Clinical Trial 2023: Rituximab Highlights & Side Effects. Trial Name: NCT05786040 — Phase 2
Rituximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05786040 — Phase 2

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
~12 spots leftby Dec 2024