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
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Blood & Marrow Transplantation Center, RuiJin Hospital
RECRUITING
Shanghai
Department of Hematology, Shanghai No 6 Hospital
RECRUITING
Shanghai
Shanghai ZhaXin Hospital
RECRUITING
Shanghai
Contact Information
Primary
Jiong HU
hj10709@rjh.com.cn
86-21-64370045
Backup
Jieling Jiang
jiangjieling66@hotmail.com
+8613311986505
Time Frame
Start Date:2023-02-01
Estimated Completion Date:2026-09-01
Participants
Target number of participants:100
Treatments
Experimental: CLAGE-VEN-RIC-Conditioning
Cladribine: 5mg/m2 day -21 to d -17 cytarabine: 1g/m2 day -21- to d -17 etoposide: 100mg/m2 day -17 to -15 venetoclax: 100mg day-21; 200mg day -20, 400mg day -19 to day-3 Fludarabine: 30mg/m2 day -7 to -3 Busulfan: 3.2mg/kg day -6 to -5 Melphalan: 50mg/m2 day -4 to -3. or Fludarabine 30mg/m2 day -7 to -3 Total marrow irradiation day-5 to -3 PBSC: day 0~Conditioning regimen cane delayed to in patients with ongoing active infection or work-up of donors after CLAGE-VEN chemotherapy based on clinicians' decision. Patients receiving all-HSCT in cytopenia are classified as sequential while patients with recovered CBC are considered as bridging transplantation.