Clinical trial · Interventional
Durvalumab in DLBCL After Autologous Transplant
A Phase II Trial Investigating the Benefit of Immunotherapy With Durvalumab After Autologous Transplant in High-risk Diffuse-large B-cell Lymphomas (the IDA-D Trial)
NCT03241017CI-TRIAL-00032426IDA-DwithdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Celgene withdrew the support for this study (Durvalumab cannot be provided)
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Durvalumab
- description
- Durvalumab 1500 mg (day 1) given every 4 weeks for a total of 12 applications (1 year).
- interventionNames
- Drug: Durvalumab
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 24 months
- description
- Number of Patients with Progression-free survival (PFS) two years after autologous stem cell transplantation (ASCT) in high-risk DLBCL patients receiving PD-L1 inhibition with durvalumab.
Secondary outcomes (5)
- measure
- Response Rate
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.