Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05774028
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-17
First Post:
2023-03-07
Brief Title:
Pegaspargase Combined With Gemcitabine Etoposide Liposomal Mitoxantrone Hydrochloride and Dexamethasone P-GEMD in the Treatment of Untreated Early Non-upper Respiratory Tract or Advanced Extranodal NKT-cell Lymphoma
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
A Single-arm Multi-center Phase II Clinical Study on Pegaspargase Combined With Gemcitabine Etoposide Liposomal Mitoxantrone Hydrochloride and Dexamethasone P-GEMD in the Treatment of Untreated Early Non-upper Respiratory Tract or Advanced Extranodal NKT-cell Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
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:
NKT-cell lymphoma NKTCL is one of the most common types of extranodal lymphomaNKTCL originates from NK cells and T lymphocytes and is highly invasive There is a lack of efficient and specific treatment methods in clinical practice and the prognosis is poor The molecular heterogeneity of NKTCL is strong and molecular typing and risk stratification are of great significance for understanding the disease and improving the curative effectBased on the preclinical studies of mitoxantrone liposomes the investigators put forward a hypothesis mitoxantrone liposome injection combined with pegaspargase gemcitabine and dexamethasone P-GEMD in the treatment of early non-upper respiratory digestive tract It is safe and can improve the therapeutic effect in patients with gastric or advanced extranodal NKT cell lymphoma
Detailed Description:
NKT-cell lymphoma NKTCL is one of the most common types of extranodal lymphomaNKTCL originates from NK cells and T lymphocytes and is highly invasive There is a lack of efficient and specific treatment methods in clinical practice and the prognosis is poor The molecular heterogeneity of NKTCL is strong and molecular typing and risk stratification are of great significance for understanding the disease and improving the curative effect
In the phase II clinical study of mitoxantrone liposome 108 patients with relapsed and refractory PTCL received mitoxantrone liposome monotherapy and the IRC evaluation ORR was 417 323 515 the CR rate was 231 25108 the median PFS was 85 months and the median OS was 228 months The safety was tolerable and the efficacy was definite Based on this Mitoxantrone liposome was approved for marketing for the treatment of adult patients with relapsed and refractory PTCL
Based on the preclinical studies of mitoxantrone liposomes the investigators put forward a hypothesis mitoxantrone liposome injection combined with pegaspargase gemcitabine and dexamethasone P-GEMD in the treatment of early non-upper respiratory digestive tract It is safe and can improve the therapeutic effect in patients with gastric or advanced extranodal NKT cell lymphoma
In the phase II clinical study of mitoxantrone liposome 108 patients with relapsed and refractory PTCL received mitoxantrone liposome monotherapy and the IRC evaluation ORR was 417 323 515 the CR rate was 231 25108 the median PFS was 85 months and the median OS was 228 months The safety was tolerable and the efficacy was definite Based on this Mitoxantrone liposome was approved for marketing for the treatment of adult patients with relapsed and refractory PTCL
Based on the preclinical studies of mitoxantrone liposomes the investigators put forward a hypothesis mitoxantrone liposome injection combined with pegaspargase gemcitabine and dexamethasone P-GEMD in the treatment of early non-upper respiratory digestive tract It is safe and can improve the therapeutic effect in patients with gastric or advanced extranodal NKT cell lymphoma
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None