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

Conditions

• Monomorphic B-Cell Post-Transplant Lymphoproliferative Disorder
• Polymorphic Post-Transplant Lymphoproliferative Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biopsy — PROCEDURE
  Undergo biopsy
• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Computed Tomography — PROCEDURE
  Undergo CT
• Positron Emission Tomography — PROCEDURE
  Undergo PET
• Rituximab — BIOLOGICAL
  Given IV or SC
• Tafasitamab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Mar 23, 2023

Status verified

Feb 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

28 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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.

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

• The Ohio State Comprehensive Cancer Center
  800-293-5066
  [email protected]

Locations (4)

Find similar trials in New Brunswick, NJ