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BLINAtumomab After R-CHOP Debulking Therapy for Patients With Richter Transformation

NCT03931642 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-05-24

No results posted yet for this study

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

  • Richter Syndrome

Interventions

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

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • French Innovative Leukemia Organisation

    lead OTHER

Principal Investigators

  • Romain GUIEZE · University Hospital, Clermont-Ferrand

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-05
Primary Completion
2021-10-01
Completion
2022-10-21

Countries

  • France

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03931642 on ClinicalTrials.gov