Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870995
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-05-13
Brief Title:
Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for Refractory Acute Myelodi Leukemia
Sponsor:
Shanghai Jiao Tong University School of Medicine
Organization:
Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
A Phase II Single Arm Study of Cladribine Cytarabine Etoposide and Venetoclax Sequential With Reduced Dose Conditioning of Fludarabine Busulfan and Melphalan or Total Marrow Radiation for Refractory Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2023-11
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:
The investigators developed a protocol combining chemotherapy of cladribine cytarabine and etoposide CLAGE as debulking treatment sequential with reduced intensity conditioning regimen Flu-Bu to treat patients with refractory acute myeloid leukemia AML In this study the aim is to further evaluate the efficacy and feasibility of the protocol with modifications 1 reduced dose of CLAGE 2 Reduced intensity conditioning RIC regimen as fludarabine busulfan and melphalan MBF or total marrow irradiation TMI 3 Venetoclax was added to the chemotherapy and conditioning regimen
Detailed Description:
Refractory AML is associated with poor prognosis Allogeneic stem cell transplantation is considered as the only curative therapy Unfortunately conventional transplantation protocol usually has high relapse rate and high nor-relapse mortality In previous studies the investigators established a protocol using intensive chemotherapy cladribine cytarabine and etoposide to reduced the leukemia burden followed by reduced intensity conditioning regimen of Flu-Bu3 with 7 day interval All patients received maintenance therapy The 1-year relapse rate was less than 20 but toxicity such as lethal infection was documented in sizable part of patients In this study the aim is to further evaluate the efficacy and feasibility of the protocol with following modifications 1 dose of cytarabine and etoposide are reduced to 1gm2 and 100mgm2 daily 2 conditioning regimen is based on Flu-Bu2 combined with addition of melphalan 100mgm2 or total marrow irradiation TMI in case of contra-indication for busulfan or melphalan 3 Venetoclax is added to the chemotherapy and conditioning regimen The modifications intend to reduce both the toxicities and relapse which may turn into a benefit of disease-free survival DFS This is designed as a phase II multi-center prospective study to evaluate the feasibility and efficacy of the protocol
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