Overview

Durvalumab in DLBCL After Autologous Transplant

Status:
Withdrawn
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
The trial assess the progression-free survival (PFS) two years after autologous stem cell transplantation (ASCT) in high-risk DLBCL patients receiving PD-L1 inhibition with durvalumab.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital Inselspital, Berne
Collaborator:
Celgene
Treatments:
Antibodies, Monoclonal
Durvalumab
Criteria
Inclusion Criteria:

- Patients with any types of DLBCL (de novo or transformed), including double-hit
lymphomas, grey zone lymphomas, double or triple expressor lymphomas, unclassifiable
aggressive lymphoma types or aggressive lymphomas.

- Lymphoma patients (as listed above) in first remission considered as high-risk and
defined as lymphoma patients not achieving a complete first remission after induction
treatment before subsequent ASCT; or patients in second remission considered as
high-risk and defined as lymphoma patients relapsing within 12 months after first-line
treatment or lymphoma patients not achieving a complete second remission after salvage
treatment before subsequent ASCT.

- ECOG 0-2

- Age 18-75 years

- Female patients of child-bearing potential must have a negative pregnancy test (urine
or serum) within 14 days prior to study treatment, and they must implement adequate
measures (hormonal treatment p.o. or i.m., intra uterine surgical devices, or latex
condoms) to avoid pregnancy during study treatment and for additional 12 months.

- Patients must have given voluntary written informed consent.

Exclusion Criteria:

- Other types of malignant lymphomas

- Previous treatment with antibodies against PD-(L)1

- Symptomatic CNS (Central Nervous System) involvement by lymphoma

- Active infection requiring antibiotic/antifungal treatment

- Lack of patient cooperation to allow study treatment as outlined in this protocol

- Pregnancy or lactating female patients

- Major surgery less than 30 days before start of treatment

- Contraindications and hypersensitivity to any of the active chemotherapy compounds