Status:
WITHDRAWN
Durvalumab in DLBCL After Autologous Transplant
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Celgene
Conditions:
Lymphoma, Large B-Cell, Diffuse
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Detailed Description
Background and Rationale: Autologous stem cell transplantation (ASCT) is standard of care in the treatment concept of adult patients with multiple myeloma (MM), malignant lymphomas (including diffuse...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03241017
Start Date
October 1 2017
End Date
December 1 2021
Last Update
April 9 2018
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