Recruiting

Phase 2

Tafasitamab & RituximabTafasitamab and Rituximab for Front-Line Treatment of Post-Transplant Lymphoproliferative Disorder

Sponsor:

Timothy Voorhees

Code:

NCT05786040

Conditions

Monomorphic B-Cell Post-Transplant Lymphoproliferative Disorder

Polymorphic Post-Transplant Lymphoproliferative Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy

Biospecimen Collection

Computed Tomography

Positron Emission Tomography

Rituximab

Study Details

Brief summary:

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

Monomorphic B-Cell Post-Transplant Lymphoproliferative Disorder

Polymorphic Post-Transplant Lymphoproliferative Disorder

Study ID

NCT05786040

Start date

Mar 23, 2023

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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 Criteria:

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

Study Design

Enrollment

28 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (tafasitamab, rituximab)

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.

Interventions

Biopsy

Undergo biopsy

Biospecimen Collection

Undergo collection of blood samples

Computed Tomography

Undergo CT

Positron Emission Tomography

Undergo PET

Rituximab

Given IV or SC

Tafasitamab

Given IV

Primary outcome measure

Rate of patients who achieve a complete response (CR) [ Time Frame: within 1 week after 4 cycles of combined therapy ]

Central Contacts and Locations

Central contacts

The Ohio State Comprehensive Cancer Center

800-293-5066 OSUCCCClinicaltrials@osumc.edu

Locations

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Anita A. Trupiano

732-454-9795 ar2069@cinj.rutgers.edu

Principal Investigator:

Joanna Rhodes, MD

University of North Carolina-Hillsborough Campus

Recruiting

Hillsborough, North Carolina, United States, 27278

Contacts

Christopher E. Dittus, DO, MPH

919-966-4431 chris_dittus@med.unc.edu

Elyse Schmidt

919-966-4432 elyse_schmidt@med.unc.edu

Principal Investigator:

Christopher E. Dittus, DO, MPH

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Timothy J. Voorhees, MD, MSCR

614-293-6943 timothy.voorhees@osumc.edu

Principal Investigator:

Timothy J. Voorhees, MD, MSCR

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Lindsey Gilstrap

801-213-5652 lindsey.gilstrap@hci.utah.edu

Rachel Kingsford

801-585-0115 rachel.kingsford@hci.utah.edu

Principal Investigator:

Narendranath Epperla, MD

More Information

Sponsor

Timothy Voorhees

Last update posted

Apr 14, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Timothy Voorhees on 2026-04-14.