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A Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Primary Plasma Cell Leukemia

Plasma Cell Leukemia Clinical Trial

Official title:
A Prospective, Single-center, Phase II Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Newly Diagosed Primary Plasma Cell Leukemia

Clinical Trial Summary

This is a single-arm, open-label study to evaluate the efficacy and safety of VRD-based Regimen (Bortezomib, Lenalidomide and Dexamethasone) combined with CART-ASCT-CART2 in Chinese patients with newly diagnosed primary plasma cell leukemia.

Clinical Trial Description

The study is a prospective, single-arm, single-centre, phase II study designed to evaluate the efficacy and safety of treatment with VRD-based Regimen (Bortezomib, Lenalidomide and Dexamethasone) in combination with CART-ASCT-CART2 in Chinese patients with newly diagnosed primary plasma cell leukemia. Patients receive 3 cycles of induction therapy with VRD-based regimen followed by the first infusion of CAR-T cells. Patients then received 3 cycles of VR-based consolidation therapy, followed by ASCT and the second infusion of CAR-T cells. And R or R maintenance starts on day 100 after ASCT. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05870917
Study type Interventional
Source Institute of Hematology & Blood Diseases Hospital, China
Contact Gang An, PhD&MD
Phone 86-022-23909171
Email angang@ihcams.ac.cn
Status Recruiting
Phase Phase 2
Start date April 25, 2023
Completion date April 2027
View Details
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