NCT05786040 · Timothy Voorhees
Tafasitamab and Rituximab for Front-Line Treatment of Post-Transplant Lymphoproliferative Disorder
What this study 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.
View original scientific description
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.
Interventions
PROCEDURE
Biopsy
Undergo biopsy
PROCEDURE
Biospecimen Collection
Undergo collection of blood samples
PROCEDURE
Computed Tomography
Undergo CT
PROCEDURE
Positron Emission Tomography
Undergo PET
BIOLOGICAL
Rituximab
Given IV or SC
BIOLOGICAL
Tafasitamab
Given IV
Primary outcome measures
Rate of patients who achieve a complete response (CR)
Time frame: within 1 week after 4 cycles of combined therapy
Assessed using Lugano criteria. Will be calculated as the number of patients who achieve CR divided by the number of evaluable patients, and presented with the 95% binomial confidence interval.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
- Age \>= 18 years at the time of consent
- Karnofsky scale \> 30% or Eastern Cooperative Oncology Group (ECOG) =\< 3 (can be assessed after pre-phase steroids)
- 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
- Measurable disease of \> 1.5 cm in diameter and/or bone marrow involvement
- Subjects having undergone heart, lung, liver, kidney, pancreas, small intestine transplantation or a combination of the organ transplantations mentioned
- No prior lines of therapy for PTLD (palliative radiation, steroids, antiviral therapy, and reduction in immunosuppression are allowed)
- Human immunodeficiency virus (HIV) infection is all
Where
- New Brunswick, New Jersey
- Hillsborough, North Carolina
- Columbus, Ohio
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 14, 2026 · Source of record for eligibility and locations