Clinical trial · Interventional
A Risk Stratified Sequential Treatment With Rituximab, Brentuximab Vedotin and Bendamustine (RBvB)
A Phase II Multicenter Open Label Risk Stratified Sequential Treatment With Rituximab, Brentuximab Vedotin and Bendamustine (RBvB) in Patients Newly Diagnosed.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding
Summary
Brief summary (as posted)
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).
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Classical Hodgkin Lymphoma Type PTLD | — | UNRESOLVED | — |
| Florid Follicular Hyperplasia PTLD | Florid Follicular Hyperplasia PTLD | ONTOLOGY_EXACT | 0.98 |
| Hematopoietic/Lymphoid Cancer | — | UNRESOLVED | — |
| Infectious Mononucleosis | — | UNRESOLVED | — |
| Lymphoid Tumor | Lymphocytic Neoplasm | ALIAS | 0.90 |
| Monomorphic PTLD | — | UNRESOLVED | — |
| Plasmacytic Hyperplasia PTLD | Plasmacytic Hyperplasia PTLD | ONTOLOGY_EXACT | 0.98 |
| Polymorphic PTLD | Polymorphic PTLD | ONTOLOGY_EXACT |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Brentuximab Vedotin | Drug | Brentuximab Vedotin | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Low Risk
- description
- Low risk patients (those in complete response (CR) after induction) will receive rituximab (375mg/m2) and brentuximab vedotin (1.8mg/m2) on day 1 of 21 day cycles, for 4 cycles.
- interventionNames
- Drug: Rituximab
- Drug: Brentuximab Vedotin
- type
- ACTIVE_COMPARATOR
- label
- High Risk
- description
- High risk patients (those who do not achieve a CR after induction), will receive rituximab (375mg/m2) and brentuximab vedotin (1.8mg/m2) on day 1 and bendamustine (90mg/m2) on day 1-2 of 21 day cycles for up to 8 cycles. Interim imaging will be performed in cycle 4 (days 14-21) and patients achieving CR will receive additional 2 cycles for a total of 6, patients achieving partial response (PR) will receive 4 additional cycles.
- interventionNames
- Drug: Rituximab
- Drug: Brentuximab Vedotin
- Drug: Bendamustine
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available