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Trial Title:
Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for Refractory Acute Myelodi Leukemia
NCT ID:
NCT05870995
Condition:
Refractory Leukemia
Conditions: Official terms:
Leukemia
Conditions: Keywords:
refractory AML, allogeneic stem cell transplantation
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CALGE-VEN- RIC-conditioning
Description:
Intensive chemotherapy Cladribine-cytarabine-etoposide -venetoclax sequential with
fludarabine, busulfan and melphalan or fludarabine and total marrow irradiation
Arm group label:
CLAGE-VEN-RIC-Conditioning
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- patients with refractory AML: no remission after 2 induction therapy, relapsed AML
within 6 months of 1st CR, relapse AML fail to having CR after reinduction therapy,
multiple relapse and refractory relapse AML
- patients with >5% bone marrow blast by morphology or by LAIP flowcytometry at
enrollment
- patients with HLA-matched sibling donor, 9-10/10 matched unrelated donor or
haplo-identical family donor
- patients without active infection
- informed consent provided
Exclusion Criteria:
- patients with abnormal liver function (enzyme >2N or bilirubin >2N)
- patients with abnormal renal function (Scr >1.5N)
- patients with poor cardiac function （EF<45%）
Gender:
All
Minimum age:
16 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Blood & Marrow Transplantation Center, RuiJin Hospital
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiong HU, M.D.,
Phone:
86-21-64370045
Email:
hj10709@rjh.com.cn
Contact backup:
Last name:
Ling Wang, M.D.,
Phone:
86-21-64370045
Email:
cclingjar@163.com
Facility:
Name:
Department of Hematology, Shanghai No 6 Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunkang Chang
Phone:
86-21-64369181
Email:
changchunkang@sjtu.edu.cn
Facility:
Name:
Shanghai ZhaXin Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Chun Wang
Phone:
13386259777
Email:
wangc@gobroadhealthcare.com
Start date:
February 1, 2023
Completion date:
September 1, 2026
Lead sponsor:
Agency:
Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Source:
Shanghai Jiao Tong University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05870995
