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ACTIVE NOT RECRUITING
NCT05464433
PHASE1/PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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)

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2022-06-23

Completion Date

2025-11-30

Last Updated

2025-03-13

Healthy Volunteers

No

Interventions

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

Locations (6)

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Peking Union Medical College Hospital

Beijing, China

The Second Hospital of Dalian Medical University

Dalian, China

Sun Yat-Sen University Cancer Center

Guangzhou, China

The First Affiliated Hospital/School of Clinical Medicine of Guangdong Pharmaceutical University

Guangzhou, China

Jiangxi Cancer Hospital

Nanchang, China