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

NCT05870995 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-02-18

No results posted yet for this study

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.

Conditions

  • Refractory Leukemia

Interventions

DRUG

CALGE-VEN- RIC-conditioning

Intensive chemotherapy Cladribine-cytarabine-etoposide -venetoclax sequential with fludarabine, busulfan and melphalan or fludarabine and total marrow irradiation

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Chun Wang · Shanghai Zhaxin Integrated Traditional Chinese and Western Medicine Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2026-02-01
Completion
2026-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05870995 on ClinicalTrials.gov