Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-31 @ 10:26 PM
Study NCT ID:
NCT05681403
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-12
First Post:
2022-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Improved BEAM Conditioning Regimen for ASCT in Lymphoma
Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Organization:
Study Overview
Official Title:
Clinical Study of Mitoxantrone Hydrochloride Liposome, Carmostine, Etoposide and Cytarabine as Conditioning Regimen for Autologous Hematopoietic Stem Cell Transplantation in Patients With Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-10
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 single arm, open, single-center clinical study. The patients who are diagnosed with lymphoma and intend to undergo ASCT will be enrolled. The aim of this study is to investigate the efficacy and safety of the conditioning regimen using mitoxantrone hydrochloride liposome, BCNU, etoposide and cytarabine for ASCT.
Detailed Description:
High-dose chemotherapy combined with autologous hematopoietic stem cell transplantation (ASCT) is considered the standard of care for patients with chemotherapy-sensitive relapsed/refractory (R/R) non-Hodgkin's lymphoma (NHL). BEAM regimen is the most commonly used conditioning regimen for ASCT in lymphoma. But its application is limited by the adverse drug reactions. This present project is a one-arm, open, single-center clinical study. It aims to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome, carmostine, etoposide, and cytarabine as the conditioning regimen for ASCT in patients with lymphoma.
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?:
None
Is an FDA AA801 Violation?: