drugset / Trial / NCT03882203

CLAGE Sequential With Flu-Bu Conditioning for Refractory Acute Leukemia

NCT03882203

Phase 2 Completed 18 enrolled Shanghai Jiao Tong University School of Medicine
NaSingle-groupOpen-labelTreatment

Summary

For patients with refractory acute leukemia, allogeneic stem cell transplantation is the only curative therapy. Only 20% of patients may achieve long-term survival mostly due to relapse or nor-relapse mortality (NRM). In previous study, we demonstrated that intensive leukemia debulking chemotherapy FLAG-IDA sequential with Flu-BU conditioning is feasible with \~40% long-term survival. In the study, we further modified the chemotherapy with cladribine replacing fludarabine aiming a more potent anti-leukemia effect. Meanwhile, we reduce the dose of busulfan for patients with poor performance status and age over 45 aim to reduce the NRM. All patients will also receive post-transplantation maintenance therapy with low-dose decitabine to prevent relapse.

Timeline

Start
2018-08-01
Primary completion
2021-08-30
Completion
2022-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cladribine Small molecule
Subject Cytarabine Small molecule
Subject Etoposide Small molecule
Subject Fludarabine Small molecule
Subject busulifan Unknown