CLAGE-VEN Sequential With Reduced Dose MBF for Refractory AML

• Status: Recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

Summary

We 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 AML. In this study, we further evaluate the protocol with modifications: 1) reduced dose of CLAGE; 2) RIC conditioning regimen as Flu-Bu-Mel; 3) Venetoclax was added to the chemotherapy and conditioning regimen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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%）