Study Details

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Tafasitamab and Rituximab for Front-Line Treatment of 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. This study is being done to study whether treating PTLD with a combination of the drugs tafasitamab and rituximab is more effective than rituximab alone - the current standard of care treatment for this disease.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

During the first 4 weeks of the study, you will come into UNC to receive doses of the study drugs, rituximab and tafasitamab, intravenously. If you respond to treatment, then you will be eligible to continue on the combination therapy every 21 days for up to three more months. During your participation, you will complete assessments including blood tests and scans to check on your cancer. These tests and assessments will be used to evaluate your response to the treatment you are receiving. After completing treatment, the study team will follow up with you for 3 years to see how you are doing after you stop the study therapy.

In-person visits:
16-20

Total length of participation:
4 weeks treatment (+ up to 3 more months if you respond to treatment) + 3 years Follow-up

Looking for Specific Volunteers

Able to participate:

You have been diagnosed with B-cell post-transplant lymphoproliferative disorder (PTLD) after an organ transplant
You have not received therapy for PTLD yet
You are an adult with adequate organ function
You are not pregnant

Not eligible if:

You have uncontrolled heart disease
You currently have an active infection
You were diagnosed with PTLD after liquid transplantation

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Christopher Dittus
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Blood Conditions
Cancer (Lymphoma)
Transplant

IRB Number

23-1355

ClinicalTrials.gov

NCT05786040