Clinical trial · Interventional
Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
An Open Label Phase 2 Study of Denintuzumab Mafodotin (SGN-CD19A) in Combination With RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) Compared With RCHOP Alone as Frontline Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) Grade 3b
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision based on portfolio prioritization
Summary
Brief summary (as posted)
This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse, Large B-Cell, Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Follicular Lymphoma, Grade 3b | Grade 3b Follicular Lymphoma | ALIAS | 0.90 |
| Transformed Lymphoma / DLBCL | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| denintuzumab mafodotin | Drug | — | UNRESOLVED |
| doxorubicin | Drug | Doxorubicin | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| rituximab | Drug | Rituximab | ALIAS |
| vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- denintuzumab mafodotin + RCHOP
- description
- Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
- interventionNames
- Drug: denintuzumab mafodotin
- Drug: rituximab
- Drug: cyclophosphamide
- Drug: doxorubicin
- Drug: vincristine
- Drug: prednisone
- type
- EXPERIMENTAL
- label
- denintuzumab mafodotin + RCHP
- description
- Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)
- interventionNames
- Drug: denintuzumab mafodotin
- Drug: rituximab
- Drug: cyclophosphamide
- Drug: doxorubicin
- Drug: prednisone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Treatment-naive patients with histologically confirmed systemic de novo or transformed diffuse large B-cell lymphoma (DLBCL) (from follicular or marginal zone lymphoma), or follicular lymphoma (FL) Grade 3b; * patients must have high intermediate or high risk disease * Tumor tissue available from most recent biopsy to determine cell of origin * Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease greater than 1.5cm diameter * Eastern Cooperative Oncology Group performance status ≤2 * Age 18 years or older * Adequate study baseline laboratory parameters Exclusion Criteria: * Previous history of treated indolent lymphoma * History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years * History of progressive multifocal leukoencephalopathy * Cerebral/meningeal disease related to the underlying malignancy * Patients with the following ocular conditions: corneal disorders, monocular vision (ie. best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring treatment
References
Publications (0)
Data not yet available