Mitoxantrone Hydrochloride Liposome Injection-containing Bridging Regimen and CD19-targeting CAR-T Therapies
Condition(s) studied
Investigational drug(s) / intervention(s)
Mitoxantrone hydrochloride liposome Injection-based bridging therapy+ Fludarabine-based chemotherapy +CD19 CAR-T Cells: Bridging therapies from enrollment before CD19 CAR-T infusion. A treatment regimen containing mitoxantrone hydrochloride liposome injection, including but not limited to the following recommended regimens: R-MINE regimen (rituximab + ifosfamide + mitoxantrone hydrochloride liposome + etoposide) G-MINE regimen (obinutuzumab + ifosfamide + mitoxantrone hydrochloride liposome + etoposide) MAE regimen (mitoxantrone liposome hydrochloride + cytarabine + etoposide) . The recommended dose of mitoxantrone liposome hydrochloride is not limited. For patients who achieve SD or better after one cycle of bridging treatment, it is up to the investigator to decide whether to receive CAR-T therapy. Fludarabine-based lymphodepletion chemotherapy was followed by CD19 CAR-T cells (relma-cel, axi-cel or humanized CAR19). Relma-cel and axi-cel will be infused according to the instructions. CART19 infusion is conducted at a dose of 1x10\^6/kg on day 0 and day 1 respectively.
Study summary
The goal of this open, single-arm practical, phase II, clinical study is to evaluate the efficacy and safety of the mitoxantrone hydrochloride liposome injection-containing regimens in bridging therapies of CD19 CAR-T cells. The main question it aims to answer is:
• the efficacy of the mitoxantrone hydrochloride liposome injection-containing combination regimens in bridging therapies of CD19 CAR-T cells.
Participants will receive combination bridging regimens including mitoxantrone hydrochloride liposomal injection and CAR-T cell therapy to see if the combination regimens have a positive effect on the efficacy of bridging therapies.
Eligibility
Primary outcome measure(s)
- The overall response rate (ORR) of patients after bridging therapy — After bridging therapy and before CD19 CAR-T infusion
The overall response rate (ORR) was based on the Lugano 2014 Lymphoma Efficacy Evaluation Criteria (Cheson 2014) and the 2021 version of the ALL Efficacy Evaluation Index
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Union Hospital, Huazhong University of Science and Technology | Wuhan | Hubei |
More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06220097 on ClinicalTrials.gov ↗ ← All trials in China