Tafasitamab and Rituximab for Post-Transplant Lymphoproliferative Disorder
This study is testing if a combination of two medications, tafasitamab and rituximab, can effectively treat post-transplant lymphoproliferative disorder (PTLD) in people who have recently had a transplant. PTLD is a type of lymphoma that can occur after an organ transplant. Both tafasitamab and rituximab are monoclonal antibodies, which are special proteins that can help your body fight cancer cells. Researchers want to see how many patients achieve a complete response (meaning all signs of cancer disappear) after 4 cycles of this combined treatment. The study aims to enroll 28 participants aged 18 and older. The current status of this study is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 28 participants.
- What's involved
- You would undergo a biopsy, blood sample collections, and imaging tests like CT scans and PET scans. You would also receive Rituximab, given intravenously (IV) or subcutaneously (under the skin).
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal is to measure complete response within 1 week after 4 cycles of combined therapy.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05786040
Tafasitamab and Rituximab for Front-Line Treatment of Post-Transplant Lymphoproliferative Disorder
Recruiting
PHASE2Ages 18+InterventionalTreatmentTimothy VoorheesInvestigator-initiated
~28 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionComputed TomographyPositron Emission TomographyRituximabTafasitamab
At a glance
Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of patients who achieve a complete response (CR)
Measured over within 1 week after 4 cycles of combined therapy
Conditions
Where it's being run
4 sites across 4 statesNew Jersey1
North Carolina1
Ohio1
Utah1
Study leadership
- Timothy J Voorhees, MD, MSCR · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 allowed if viral load is undetectable at time of enrollment and CD4+ count \> 200 cells/uL
Expected survival greater than 30 days
Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L (obtained within 14 days prior to initiating study treatment)
Note: Hematology and other lab parameters that are =\< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
Platelets \>= 50 x 10\^9/L (obtained within 14 days prior to initiating study treatment)
Note: Hematology and other lab parameters that are =\< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
Creatinine clearance (mL/min) \>= 30 mL/min (obtained within 14 days prior to initiating study treatment)
Cockcroft-Gault Equation
Note: Hematology and other lab parameters that are =\< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
Bilirubin =\< 3.0 x upper limit of normal (ULN). Subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level \> 3.0 mg/dL if their conjugated bilirubin is =\< 3.0 x ULN) (obtained within 14 days prior to initiating study treatment)
Note: Hematology and other lab parameters that are =\< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
Aspartate aminotransferase (AST) =\< 3.0 x ULN (obtained within 14 days prior to initiating study treatment)
Note: Hematology and other lab parameters that are =\< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
Alanine aminotransferase (ALT) =\< 3.0 x ULN (obtained within 14 days prior to initiating study treatment)
Note: Hematology and other lab parameters that are =\< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to registration. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of postmenopausal status must be provided
Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 12 months after treatment the last dose of rituximab or tafasitamab. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets \< 1% failure rate for protection from pregnancy in the product label
Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 12 months after the last dose of rituximab
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
Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee
Exclusion
Uncontrolled active infection. Patients requiring systemic therapy are eligible if the infection is deemed controlled by the investigator
Post-transplant lymphoproliferative disorder following liquid transplantation
Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study and lactating females must agree to not breastfeed while taking study drugs)
Subjects with central nervous system (CNS) involvement by PTLD
Uncontrolled concomitant illness including, but not limited to, symptomatic congestive heart failure (New York Heart Association \[NYHA\] class III or IV), unstable angina pectoris, myocardial infarction within 1 month prior to enrollment, uncontrolled cardiac arrhythmias, uncontrolled seizures, or severe non-compensated hypertension (systolic blood pressure \>= 180 mmHg or diastolic blood pressure \>= 120 mmHg)
History of progressive multifocal leukoencephalopathy
Active hepatitis B infection with positive viral polymerase chain reaction (PCR) from the blood. Subjects with active hepatitis B infection and undetectable viral PCR from the blood will be allowed with concurrent use of entecavir suppression
Prior treatment for PTLD with the exception of radiation, antivirals, steroids and reduced immunosuppression
Electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant
Any condition, including the presence of laboratory values which is deemed by the clinician to place the subject at an unacceptable risk or confounds the ability to interpret the data from this study
Live virus vaccines must not be administered within 28 days of the start of study treatment
Any investigational treatments must have been completed at least 7 days prior to the start of study treatment
What this trial measures
- Rate of patients who achieve a complete response (CR)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.