Clinical trial · Interventional
A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL
A Randomized Phase IIb Placebo-controlled Study of R-ICE Chemotherapy With and Without SGN-40 (Anti-CD40 Humanized Monoclonal Antibody) for Second-line Treatment of Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
NCT00529503CI-TRIAL-00016932terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40.
Conditions
Conditions (2)
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 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| placebo | Drug | — | UNRESOLVED |
| rituximab | Drug | Rituximab | ALIAS |
| SGN-40 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- SGN-40, rituximab, etoposide, carboplatin, ifosfamide
- interventionNames
- Drug: SGN-40
- Drug: rituximab
- Drug: etoposide
- Drug: carboplatin
- Drug: ifosfamide
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- placebo, rituximab, etoposide, carboplatin, ifosfamide
- interventionNames
- Drug: placebo
- Drug: rituximab
- Drug: etoposide
- Drug: carboplatin
- Drug: ifosfamide
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of de novo or transformed DLBCL, or follicular grade 3b lymphoma. * Received at least four cycles of first-line therapy with R-CHOP, or equivalent. * Best clinical response to first-line therapy of stable disease, partial response, or complete response. * At least one measureable lesion that is both greater than or equal to 1.5cm by radiographic imaging and by positive FDG-PET scan. Exclusion Criteria: * Leptomeningeal or central nervous system lymphoma. * Received any therapy for relapsed or progressive disease except for local radiation, steroids, or rituximab. * Received a hematopoietic stem cell transplant.
References
Publications (1)
- RESULTFayad L, Ansell SM, Advani R, Coiffier B, Stuart R, Bartlett NL, Forero-Torres A, Kuliczkowski K, Belada D, Ng E, Drachman JG. Dacetuzumab plus rituximab, ifosfamide, carboplatin and etoposide as salvage therapy for patients with diffuse large B-cell lymphoma relapsing after rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone: a randomized, double-blind, placebo-controlled phase 2b trial. Leuk Lymphoma. 2015;56(9):2569-78. doi: 10.3109/10428194.2015.1007504. Epub 2015 Feb 26. PMID 25651427