BLINAtumomab After R-CHOP Debulking Therapy for Patients With Richter Transformation
|ClinicalTrials.gov Identifier: NCT03931642|
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : July 19, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Richter Syndrome||Drug: RCHOP Drug: Blinatumomab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||BLINAtumomab After R-CHOP Debulking Therapy for Patients With Richter Transformation|
|Actual Study Start Date :||July 5, 2019|
|Estimated Primary Completion Date :||July 4, 2021|
|Estimated Study Completion Date :||July 4, 2022|
Experimental: R-CHOP- blinatumomab
Patients will first undergo a prior debulking therapy including 2 cycles of R-CHOP.
At Day1 (D1) : Rituximab 375 mg/m² Intravenous (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 Per Os (PO). Patients with CR and no measurable lesion left will not be treated further in the setting of the present trial. All the remaining patients will be continuing and treating on study with a single cycle of blinatumomab induction therapy : Blinatumomab at 9 μg/d IV by continuous vein infusion from day 1-7, 28 μg/d from day 8-14 and 112 μg/d from day 15-56.
Patients who achieve an objective response after induction are eligible to receive one further optional cycle of blinatumomab consolidation : blinatumomab 9 μg/d IV by continuous vein infusion from day 1-7, 28 μg/d from day 8-14 and 112 μg/day IV from day 15-28.
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.
Blinatumomab by continuous vein infusion
- Complete remission (CR) rate according to the revised Lugano criteria [ Time Frame: at week 16 from baseline ]the objective response rate to one 8-week cycle of blinatumomab following a debulking therapy with 2 R-CHOP cycles
- Number of patients with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: From the first treatment administration and during treatment period (R-CHOP and blinatomomab) ]safety and toxicity of blinatumomab after 2 cycles of R-CHOP
- overall response [ Time Frame: At week 16 from baseline, after blinatumomab induction and at week 24 after blinatumomab consolidation. ]Overall response rate (revised Lugano criteria) after the first and second cycle of blinatumomab,
- CR rate [ Time Frame: After blinatumomab consolidation (total of 4 weeks) at week 24 from the beginning of study treatment. ]CR rate (revised Lugano criteria) after the second cycle of blinatumomab
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931642
|Contact: Laetitia AUVRAY||0785226327 ext email@example.com|
|Contact: Valérie ROUILLE||0467332645 ext firstname.lastname@example.org|
|Principal Investigator:||Romain GUIEZE||University Hospital, Clermont-Ferrand|