NCT05464433

Tislelizumab Combined with Mitoxantrone Hydrochloride Liposome in Extranodal Natural Killer/T Cell Lymphoma

Open-Label, PhaseIb/Ⅱ Study of Tislelizumab and Mitoxantrone Hydrochloride Liposome Combination Treatment in Patients with Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma（ALLIANCE-022）

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-label, single arm, multicenter clinical study to evaluate the safety, tolerability, efficacy in combination with tislelizumab and mitoxantrone hydrochloride liposome combination treatment in patients with relapsed or refractory Extranodal Natural Killer/T Cell Lymphoma（NKTCL）

Detailed description

This is a prospective, open-label, single arm, multicenter clinical study to explore the maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride when combined with tislelizumab in patients with relapsed or refractory Extranodal Natural Killer/T Cell Lymphoma（NKTCL）. Liposomal mitoxantrone hydrochloride will be given on day 1 at two different doses (16 mg/m2, 20 mg/m2) and be combined with tislelizumab. The dose limited toxicity (DLT) will be evaluated after the first cycle of therapy. A maximum of 6 cycles of therapy are planned. An dose expansion study of mitoxanquinone hydrochloride liposome at recommended phaseII dose (RP2D) dose level combined with tirelizumab was conducted to explore the efficacy and safety tolerance of the combined regimen. After 6 cycles of induction therapy, if the outcome was assessed as complete remission (CR)/partial remission (PR)/Stable disease (SD), continued maintenance therapy with tirelizumab.

Conditions

• Extranodal Natural Killer T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Tislelizumab combined with Liposomal mitoxantrone hydrochloride	Drug: liposomal mitoxantrone hydrochloride, tislelizumab Drug: Liposomal mitoxantrone hydrochloride (16 mg/m2, 20 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle. Drug: tislelizumab(200 mg) will be taken orally on day 1 of each 28-day cycle.
DRUG	Maintenance of tislelizumab	Drug: tislelizumab(200 mg) will be taken orally on day 1 of each 21-day cycle

Timeline

• Start date: 2022-06-23
• Primary completion: 2025-04-30
• Completion: 2025-11-30
• First posted: 2022-07-19
• Last updated: 2025-03-13

Locations

6 sites across 1 country: China