Overview

A Risk Stratified Sequential Treatment With Rituximab, Brentuximab Vedotin and Bendamustine (RBvB)

Status:
Not yet recruiting

Trial end date:
2023-12-01

Target enrollment:
0

Participant gender:
All

Summary

This is an open label, risk-stratified, sequential treatment, phase 2 study of newly diagnosed post-transplant lymphoproliferative disorders with positive CD20 and CD30 expression. It includes an induction phase with rituximab and brentuximab vedotin (RBv), followed by a treatment phase with RBv or RBv in combination with bendamustine (RBvB) based on response to induction. The primary end point is treatment efficacy measured as the overall response rate (ORR) and progression free survival (PFS).

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Francesca Montanari
Yale University

Collaborator:

Mayo Clinic

Treatments:

Antibodies, Monoclonal
Bendamustine Hydrochloride
Brentuximab Vedotin
Rituximab

Criteria

Inclusion Criteria:

1. Age ≥ 18 and ≤ 70 at the time of signing informed consent

2. Patient must have histologically confirmed newly diagnosed polymorphic or monomorphic
PTLD defined according to the 2016 World Health Organization (WHO) classification
criteria.

3. Diagnostic archival tissue available for review and correlative studies

4. Previous solid organ or allogeneic hematopoietic stem cell transplant

5. Measurable disease

6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

7. Patients must have adequate organ and marrow function

8. Negative urine or serum pregnancy test for women of childbearing potential

9. Patients must be able to understand and to sign a written consent document.

Exclusion Criteria:

1. Previous treatment for PTLD with the exception of immunosuppression reduction

2. Known involvement of the central nervous system by the PTLD

3. Known allergic reactions against foreign proteins

4. Uncontrolled inter-current illness including active infection, acute graft versus host
disease and/or transplant organ rejection

5. Active concurrent malignancy with the exception of non-melanoma skin cancer, carcinoma
in situ of the cervix or localized prostate cancer

6. Severe non-compensated diabetes mellitus

7. Pre-existing neuropathy grade 2 or greater

8. Pregnant or lactating

9. Psychiatric illness / social situations that would limit compliance with study
requirements

10. Patients with previous hypersensitivity to Rituximab

11. Known HIV positive.