Clinical trial · Interventional
A Study of Durvalumab in Combination With R-CHOP or Lenalidomide Plus R-CHOP in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma
A Phase 2, Open-label, Multicenter Study to Evaluate the Safety and Clinical Activity of Durvalumab in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) or With Lenalidomide Plus R-CHOP (R2-CHOP) in Subjects With Previously Untreated, High-Risk Diffuse Large B-Cell Lymphoma
- 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 Phase 2, two-arm, open-label study is designed to evaluate the safety, clinical activity, and predictive biomarkers of durvalumab in combination with R-CHOP or R2-CHOP, followed by durvalumab consolidation therapy in previously untreated subjects with high-risk diffuse large B-cell lymphoma (DLBCL). Induction treatment with R-CHOP (± lenalidomide) will last for a total of up to 6 to 8 treatment cycles (21 day cycles), and the total time on study treatment, including durvalumab consolidation, will last up to 12 months. On 05-Sep-2017, the US FDA has issued a Partial Clinical Hold on this study resulting in the discontinuation of enrollment into Arm B (Durvalumab + Lenalidomide + R-CHOP). After the US FDA Partial Clinical Hold, new eligible participants have been enrolled in Arm A (Durvalumab + R-CHOP).
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Durvalumab | Drug | Durvalumab | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DUR + R-CHOP
- description
- On Day 1 of each 21-day cycle, participants received durvalumab 1125 mg intravenously (IV) followed by R-CHOP (IV rituximab 375 mg/m\^2, doxorubicin 50 mg/m\^2, vincristine 1.4 mg/m\^2 (maximum dose of 2.0 mg total), and cyclophosphamide 750 mg/m\^2); Participants also were administered daily oral or IV prednisone/prednisolone 100 mg from Day 1 to 5. Induction treatment continued for a total of 6-8 cycles. Participants who achieve a complete response or partial response continue with consolidation therapy treatment consisting of durvalumab monotherapy 1500 mg by IV on Day 1 of each 28-day cycle for up to a total of 12 months.
- interventionNames
- Drug: Durvalumab
- Drug: Rituximab
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Cyclophosphamide
- Drug: Prednisone
- type
- EXPERIMENTAL
- label
- DUR + R2-CHOP
- description
- Participants start the study on durvalumab in combination with R-CHOP (as described in Arm DUR + R-CHOP). Based on their DLBCL Cell-of-Origin subtype (test typically done between cycles 1 and 2), participants with ABC subtype continue the study taking durvalumab in combination with R2-CHOP. On Day 1 of each 21-day cycle, participants received durvalumab 1125 mg intravenously (IV) followed by R-CHOP. Participants were also administered daily oral or IV prednisone/prednisolone 100 mg from Day 1 to 5. In addition, a daily oral lenalidomide 15 mg was administered from Day 1 to 14 of each 21-day cycle. Induction treatment continued for a total of 6-8 cycles. Participants who achieve a complete response or partial response continue with consolidation therapy treatment consisting of durvalumab monotherapy 1500 mg by IV on Day 1 of each 28-day cycle for up to a total of 12 months. Enrollment into Arm B was discontinued.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. CD20+Diffuse Large B-Cell Lymphoma. 2. Ann Arbor stage 3 or 4 or stage 2 with bulky disease 3. High or high-intermediate disease risk. 4. No prior anti-lymphoma treatment. 5. Subject is willing and able to undergo biopsy. 6. Investigator considers R-CHOP immunochemotherapy appropriate. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 8. Adequate hematology laboratory results (absolute neutrophil count ≥ 1.5 \* 10\^9/L, platelet count ≥ 75 \* 10\^9/L, hemoglobin ≥ 10.0 g/dL). 9. Adequate biochemistry laboratory results (aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3.0 \* upper limit of normal; bilirubin ≤ 2.0 mg/dL; creatinine clearance of ≥ 40 mL/min). 10. Bi-dimensionally measurable disease (\> 2.0 cm). 11. Subject is using effective contraception. Exclusion Criteria: 1. Diagnosis of lymphoma other than Diffuse Large B-Cell Lymphoma. 2. Composite lymphoma or transformed lymphoma. 3. Primary or secondary Central Nervous System involvement by lymphoma. 4. Seropositive or active viral infection with hepatitis B virus, human immunodeficiency virus or hepatitis C virus. 5. History of other malignancies, unless disease-free for ≥ 5 years. 6. Left ventricular ejection fraction \< 50%. 7. Peripheral neuropathy ≥ Grade 2. 8. Prior use of lenalidomide, or monoclonal antibodies against CTLA-4, PD-1, or PD-L1. 9. High risk of developing thromboembolic events, who are unwilling to take venous thromboembolism prophylaxis. 10. Active or prior documented autoimmune or inflammatory disorders within the past 3 years. 11. Current or prior use of immunosuppressive medication within 28 days before start of treatment.
References
Publications (0)
Data not yet available