NCT03931642

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

Completed Phase 2 Last updated 24 May 2023

What this trial tests

Phase 2 trial testing RCHOP in Richter Syndrome in 41 participants. Completed in 21 October 2022.

Timeline

5 July 2019

Primary endpoint
1 October 2021

21 October 2022

Quick facts

Lead sponsor	French Innovative Leukemia Organisation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	5 July 2019
Primary completion	1 October 2021
Estimated completion	21 October 2022
Sites	28 locations across France

Drugs / interventions tested

• RCHOP — full drug profile →
• Blinatumomab (blinatumomab) — full drug profile →

Conditions studied

• Richter Syndrome — all drugs for Richter Syndrome →

Sponsor

French Innovative Leukemia Organisation — full company profile →

Who can join

18 and older, any sex, with Richter Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical characteristics and outcomes of Richter transformation: experience of 204 patients from a single center.
   Wang Y, Tschautscher MA, Rabe KG, Call TG, et al · · 2020 · cited 96× · PMID 31197071 · DOI 10.3324/haematol.2019.224121
2. Biology and Treatment of Richter Transformation.
   Condoluci A, Rossi D. · · 2022 · cited 39× · PMID 35392219 · DOI 10.3389/fonc.2022.829983
3. Concepts in immuno-oncology: tackling B cell malignancies with CD19-directed bispecific T cell engager therapies.
   Viardot A, Locatelli F, Stieglmaier J, Zaman F, et al · · 2020 · cited 31× · PMID 32856140 · DOI 10.1007/s00277-020-04221-0
4. Microenvironment Remodeling and Subsequent Clinical Implications in Diffuse Large B-Cell Histologic Variant of Richter Syndrome.
   Augé H, Notarantonio AB, Morizot R, Quinquenel A, et al · · 2020 · cited 19× · PMID 33381116 · DOI 10.3389/fimmu.2020.594841
5. Treatment of Richter Transformation of Chronic Lymphocytic Leukemia in the Modern Era.
   Briski R, Taylor J. · · 2023 · cited 13× · PMID 36980742 · DOI 10.3390/cancers15061857
6. Blinatumomab after R-CHOP bridging therapy for patients with Richter transformation: a phase 2 multicentre trial.
   Guièze R, Ysebaert L, Roos-Weil D, Fornecker LM, et al · · 2024 · cited 10× · PMID 39122717 · DOI 10.1038/s41467-024-51264-2
7. Richter Syndrome: From Molecular Pathogenesis to Druggable Targets.
   Mouhssine S, Gaidano G. · · 2022 · cited 8× · PMID 36230566 · DOI 10.3390/cancers14194644
8. Treatment of Richter's Transformation with Novel Therapies.
   Bajwa A, Habib A, Kittai AS. · · 2024 · cited 6× · PMID 38194201 · DOI 10.1007/s11899-023-00721-8