Trials / Completed
CompletedNCT03931642
BLINAtumomab After R-CHOP Debulking Therapy for Patients With Richter Transformation
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- French Innovative Leukemia Organisation · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Blinatumomab (BLINCYTO) is a bi-specific T-cell engaging (BiTE®) antibody construct that transiently links CD3-positive T cells to CD19-positive B-cells, inducing T-cell activation and subsequent lysis of tumor cells. The investigators propose to evaluate the efficacy, safety and tolerability of blinatumomab administered after R-CHOP debulking therapy in patients with Richter Syndrome (RS) of diffuse large B-cell lymphoma (DLBCL) histology. The investigators hypothesize that 8-week blinatumomab induction therapy leads to Complete Response (CR) rate improvement (revised Cheson criteria) from a baseline of 7percent as observed in the prospective study evaluating R-CHOP.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RCHOP | D1 : Rituximab 375 mg/m² IV + Cyclophosphamide 750 mg/m² IV + Doxorubicin 50 mg/m² IV + Vincristine 1.4 mg/m² IV. From D1 to D5 : Prednisone 60 mg/m² PO. |
| DRUG | Blinatumomab | Blinatumomab by continuous vein infusion |
Timeline
- Start date
- 2019-07-05
- Primary completion
- 2021-10-01
- Completion
- 2022-10-21
- First posted
- 2019-04-30
- Last updated
- 2023-05-24
Locations
28 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03931642. Inclusion in this directory is not an endorsement.