Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 1g/m2 and 100mg/m2 daily; 2) conditioning regimen is based on Flu-Bu2 combined with addition of melphalan (100mg/m2) 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05870995
Study type	Interventional
Source	Shanghai Jiao Tong University School of Medicine
Contact	Jiong HU
Phone	86-21-64370045
Email	hj10709@rjh.com.cn
Status	Recruiting
Phase	Phase 2
Start date	February 1, 2023
Completion date	September 1, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05043571` - CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed/ Refractory T-Lineage Acute Lymphoblastic Leukaemia	Phase 1
Active, not recruiting	`NCT04874480` - Tegavivint for the Treatment of Relapsed or Refractory Leukemia	Phase 1
Recruiting	`NCT05519384` - Safety and Preliminary Efficacy of JK500 Cell Injection in Relapsed/Refractory Pediatric Acute Myeloid Leukemia	Early Phase 1
Completed	`NCT04597086` - Bright White Light Therapy for the Improvement of Sleep, Fatigue, Distress, Depression, and Anxiety in Hospitalized Leukemia Patients	N/A
Recruiting	`NCT05495035` - Study for Safety and Efficacy of Olverembatinib Combined With APG-2575 in Children With Relapsed/Refractory Ph + ALL	Phase 1
Withdrawn	`NCT05321940` - Safety Trial of STING-dependent Activators and Stimulated Dendritic Cells for Aggressive Relapsed/Refractory Leukemias	Phase 1
Recruiting	`NCT04722952` - PD-1 Inhibitor Combined With Azacytidine and Homoharringtonine，Cytarabine, G-CSF for Refractory or Relapsed AML	Phase 3
Recruiting	`NCT04684472` - Modified CD19 CAR-T in Patients With Relapsed or Refractory CD19+ B-cell Malignancies	Phase 1
Recruiting	`NCT04470947` - Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies
Recruiting	`NCT04282811` - Observational Study Relapsed or Refractory Chronic Lymphocytic Leukemia Venetoclax-based Regimens Outside Clinical Trials in Italy
Recruiting	`NCT05046444` - Solving Riddles Through Sequencing
Recruiting	`NCT05576532` - Venetoclax Plus IM2 Regimen for Relapsed and Refractory T Lymphoblastic Lymphoma/Leukemia	Phase 2
Recruiting	`NCT05164042` - Allogeneic CD19 CAR-T Cells for the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia	Phase 1/Phase 2
Completed	`NCT02512926` - Carfilzomib in Combination With Cyclophosphamide and Etoposide for Children	Phase 1
Recruiting	`NCT03799224` - Decitabine Plus mBU/CY Preconditioning for Relapse/Refractory Acute Leukemia	Phase 2/Phase 3
Recruiting	`NCT06006403` - Safety and Efficacy of CD123-targeted CAR-NK for Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm	Phase 1/Phase 2
Completed	`NCT00880269` - Efficacy and Safety of Panobinostat (LBH5789) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)	Phase 2
Recruiting	`NCT05305859` - Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for Refractory Acute Myelodi Leukemia

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms