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Brief Title: A Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Primary Plasma Cell Leukemia
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
Study ID: NCT05870917
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences, Tianjin, , China