NCT06224842

Clinical Study of Mitoxantrone Liposome and Azacitidine in the Treatment of R/R AITL

A Phase Ib/II Clinical Study of Mitoxantrone Liposome and Azacitidine in the Treatment of Relapsed/Refractory Angioimmunoblastic T-cell Lymphoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Huijing Wu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, single-arm Phase Ib/II clinical trial designed to evaluate the safety and efficacy of the combination therapy with mitoxantrone liposome and azacitidine in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma(R/R AITL). The study includes two parts: a dose escalation phase and a dose expansion phase, each comprising screening, treatment, and follow-up periods. In the dose escalation phase, the mitoxantrone liposome injection will start at a dose of 16 mg/m\^2 on day1, combined with subcutaneous injection of azacitidine at a dose of 75 mg/m\^2 on days 1-7, with each cycle lasting 4 weeks (28 days). Three predetermined dose groups for mitoxantrone liposome are 16, 18, and 20 mg/m\^2. In the dose expansion phase, 10-20 cases will be included with the mitoxantrone liposome injection at the recommended phase II dose (RP2D) based on the results of the dose escalation phase. After the treatment period, safety and survival information will be collected during the follow-up period. This study aims to comprehensively evaluate the safety and efficacy of mitoxantrone liposome in combination with azacitidine for the treatment of R/R AITL, exploring a combination therapy that offers higher survival benefits with limited adverse reactions and providing new therapeutic approaches for R/R AITL.

Conditions

• Angioimmunoblastic T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	mitoxantrone liposome 16 and azacitidine	The mitoxantrone liposome will be intravenous infused at a dose of 16mg/m\^2 on day1 , combined with subcutaneous injection of azacitidine at a dose of 75 mg/m\^2 on days 1-7, with each cycle lasting 4 weeks (28 days).
DRUG	mitoxantrone liposome 18 and azacitidine	The mitoxantrone liposome will be intravenous infused at a dose of 18mg/m\^2 on day1 , combined with subcutaneous injection of azacitidine at a dose of 75 mg/m\^2 on days 1-7, with each cycle lasting 4 weeks (28 days).
DRUG	mitoxantrone liposome 20 and azacitidine	The mitoxantrone liposome will be intravenous infused at a dose of 20mg/m\^2 on day1 , combined with subcutaneous injection of azacitidine at a dose of 75 mg/m\^2 on days 1-7, with each cycle lasting 4 weeks (28 days).

Timeline

• Start date: 2023-12-12
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2024-01-25
• Last updated: 2024-01-25

Locations

1 site across 1 country: China