Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 8:35 PM
Study NCT ID:
NCT05464433
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-13
First Post:
2022-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tislelizumab Combined with Mitoxantrone Hydrochloride Liposome in Extranodal Natural Killer/T Cell Lymphoma
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
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）
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: