Actively Recruiting
Tafasitamab and Rituximab for Front-Line Treatment of Post-Transplant Lymphoproliferative Disorder
Led by Timothy Voorhees · Updated on 2026-04-14
28
Participants Needed
4
Research Sites
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial tests how well tafasitamab and rituximab work for front-line treatment of patients with post-transplant lymphoproliferative disorder. Post-transplant lymphoproliferative disorder (PTLD) is the name for types of lymphoma that sometimes develop in people who have had a transplant. It can affect people who are taking medicines to suppress their immune system. Tafasitamab injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving the combination of tafasitamab and rituximab may work better in treating patients with post-transplant lymphoproliferative disorder.
CONDITIONS
Official Title
Tafasitamab and Rituximab for Front-Line Treatment of Post-Transplant Lymphoproliferative Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent and HIPAA authorization
- Age 18 years or older at consent
- Karnofsky score above 30% or ECOG score 3 or less
- Biopsy-confirmed B-cell PTLD (monomorphic or polymorphic) expressing CD19 and CD20
- Measurable disease larger than 1.5 cm or bone marrow involvement
- Received heart, lung, liver, kidney, pancreas, or small intestine transplant or combination
- No prior PTLD therapy except steroids, antiviral therapy, radiation, or immunosuppression reduction
- HIV infection allowed if viral load undetectable and CD4+ count above 200 cells/uL
- Expected survival longer than 30 days
- Absolute neutrophil count of at least 1.0 x 10^9/L within 14 days before treatment
- Platelets at least 50 x 10^9/L within 14 days before treatment
- Creatinine clearance of at least 30 mL/min within 14 days before treatment
- Bilirubin at or below 3.0 times upper limit of normal (ULN), with exceptions for Gilbert's syndrome
- AST and ALT at or below 3.0 times ULN within 14 days before treatment
- Females of childbearing potential must have negative pregnancy test within 3 days before registration
- Females of childbearing potential must use two effective contraception methods or abstain during and for 12 months after treatment
- Male participants with female partners must use contraception or have had vasectomy during and for 12 months after treatment
- Previous or current malignancies allowed if they don't interfere with study safety or results
- Willing and able to comply with study procedures
You will not qualify if you...
- Active uncontrolled infection requiring systemic therapy (controlled infections allowed)
- PTLD following liquid transplantation
- Pregnant or breastfeeding women
- PTLD involvement of the central nervous system
- Uncontrolled illnesses such as severe heart failure (NYHA class III or IV), unstable angina, recent heart attack, uncontrolled arrhythmias, seizures, or severe hypertension
- History of progressive multifocal leukoencephalopathy
- Active hepatitis B infection with positive viral PCR (suppressed infection allowed with treatment)
- Previous PTLD treatments other than radiation, antivirals, steroids, or reduced immunosuppression
- ECG abnormalities deemed medically relevant
- Any condition or lab values creating unacceptable risk or interfering with data interpretation
- Use of live virus vaccines within 28 days before starting treatment
- Participation in other investigational treatments within 7 days before starting study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
2
University of North Carolina-Hillsborough Campus
Hillsborough, North Carolina, United States, 27278
Actively Recruiting
3
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
4
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
T
The Ohio State Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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