A Phase 2 interventional study of CLAGE-FluBu in Refractory Hematologic Cancer and Allogeneic Stem Cell Transplantation, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-08-15.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 2, Interventional, and Treatment
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.
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. The most important cause of treatment failures were relapse and non-relpase mortality. The further analysis demonstrated that patients with higher bone marrow blast before allo-HSCT was associated with treatment failure and patients with poor perforce status or age over 45 had increased rate of NRM. To further optimization the protocol, we modified the chemotherapy with cladribine replacing fludarabine aiming a more potent anti-leukemia effect and replace idarubicin with VP-16. All patients will also receive post-transplantation maintenance therapy with low-dose decitabine (5mg/m2 daily for 5 days) to prevent the further reduce the relapse incidence. We anticipate LFS at 1 year should be above 50% and 1-year LFS of 20% is considered unacceptable.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's enrollment of 18 is below the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
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Exclusion Criteria:
Patients receive the study protocol: CLAGE sequential with Flu-Bu as conditioning regimen followed by low-dose decitabine maintenance
Drug: CLAGE-FluBu
Cladribine combined with cytarabine and VP16 sequential with Fludarabine combined with busulifan
leukemia-free survival
From enrollment to any event as relapse or death
Time frame: 1 year
overall survival
From enrollment to death
Time frame: 1 year
relapse rate
From enrollment to documentation of relapse
Time frame: 1 year
non relapse mortality
From enrollment to documentation of death without evidence of leukemia
Time frame: 1 year
Plan to share: No
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Shanghai Jiao Tong University School of Medicine