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

NCT05786040 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: OSU-22114NCI-2023-02048
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Rate of patients who achieve a complete response (CR)

  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.

  within 1 week after 4 cycles of combined therapy

Secondary Outcomes (6)

• Incidence of adverse events

  Up to 28 days after the last dose of tafasitamab and rituximab

• Overall response rate

  Up to 3 years

• Best overall response

  Up to 3 years

• Rate of CR after completion of consolidation treatments

  Up to 3 years

• Progression free survival

  From the date of treatment initiation to date of progression or death, whichever occurs first, censoring patients who are alive without progression at time of last known follow-up, assessed up to 3 years

Study Arms (1)

Treatment (tafasitamab, rituximab)

EXPERIMENTAL

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.

Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Biological: Rituximab; Biological: Tafasitamab

Interventions

Tafasitamab BIOLOGICAL

Given IV

Also known as: Immunoglobulin, Anti-(Human Cd19 Antigen) (Human-mus musculus Monoclonal MOR00208 Heavy Chain), Disulfide with Human-mus musculus Monoclonal MOR00208 .Kappa.-chain, Dimer, Monjuvi, MOR-00208, MOR00208, MOR208, Tafasitamab-cxix, XmAb5574

Treatment (tafasitamab, rituximab)

Positron Emission Tomography PROCEDURE

Undergo PET

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Treatment (tafasitamab, rituximab)

Rituximab BIOLOGICAL

Given IV or SC

Also known as: ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Riabni, Rituxan, Rituximab ABBS, Rituximab ARRX, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, Rituximab Biosimilar SIBP-02, rituximab biosimilar TQB2303, Rituximab PVVR, rituximab-abbs, Rituximab-arrx, Rituximab-pvvr, RTXM83, Ruxience, Truxima

Treatment (tafasitamab, rituximab)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Treatment (tafasitamab, rituximab)

Biopsy PROCEDURE

Undergo biopsy

Also known as: BIOPSY_TYPE, Bx

Treatment (tafasitamab, rituximab)

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (tafasitamab, rituximab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Timothy Voorhees: lead

Study Sites (4)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

RECRUITING

University of North Carolina-Hillsborough Campus

Hillsborough, North Carolina, 27278, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Interventions

Biopsy; Specimen Handling; Magnetic Resonance Spectroscopy; Rituximab; CT-P10; tafasitamab; Immunoglobulins; Disulfides

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals

Study Officials

• Timothy J Voorhees, MD, MSCR

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 27, 2023
• Study Start: March 23, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)