Status:
WITHDRAWN
A Risk Stratified Sequential Treatment With Rituximab, Brentuximab Vedotin and Bendamustine (RBvB)
Lead Sponsor:
Yale University
Conditions:
PTLD
Lymphoid Tumor
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 indu...
Detailed Description
Post-Transplant Lymphoproliferative Disorders (PTLD) are defined by the revised 2017 edition of the WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues as "lymphoid or plasmacytic pro...
Eligibility Criteria
Inclusion
- Age ≥ 18 and ≤ 70 at the time of signing informed consent
- Patient must have histologically confirmed newly diagnosed polymorphic or monomorphic PTLD defined according to the 2016 World Health Organization (WHO) classification criteria.
- Diagnostic archival tissue available for review and correlative studies
- Previous solid organ or allogeneic hematopoietic stem cell transplant
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Patients must have adequate organ and marrow function
- Negative urine or serum pregnancy test for women of childbearing potential
- Patients must be able to understand and to sign a written consent document.
Exclusion
- Previous treatment for PTLD with the exception of immunosuppression reduction
- Known involvement of the central nervous system by the PTLD
- Known allergic reactions against foreign proteins
- Uncontrolled inter-current illness including active infection, acute graft versus host disease and/or transplant organ rejection
- Active concurrent malignancy with the exception of non-melanoma skin cancer, carcinoma in situ of the cervix or localized prostate cancer
- Severe non-compensated diabetes mellitus
- Pre-existing neuropathy grade 2 or greater
- Pregnant or lactating
- Psychiatric illness / social situations that would limit compliance with study requirements
- Patients with previous hypersensitivity to Rituximab
- Known HIV positive.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04138875
Start Date
January 1 2022
End Date
December 1 2023
Last Update
June 23 2022
Active Locations (2)
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1
Yale University
New Haven, Connecticut, United States, 06519
2
Mayo Clinic
Rochester, Minnesota, United States, 55902