CLAGE Sequential With Flu-Bu Conditioning for Refractory Acute Leukemia
Cladribine With Intermediate Cytarabine, G-CSF and VP16 Sequential With Fludarabine and Busulifan as Condoning Regimen for Refractory Acute Leukemia
1 other identifier
interventional
18
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2018
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 18, 2019
CompletedFirst Posted
Study publicly available on registry
March 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedAugust 15, 2023
August 1, 2023
3.1 years
March 18, 2019
August 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
leukemia-free survival
From enrollment to any event as relapse or death
1 year
Secondary Outcomes (3)
overall survival
1 year
relapse rate
1 year
non relapse mortality
1 year
Study Arms (1)
treatment
EXPERIMENTALPatients receive the study protocol: CLAGE sequential with Flu-Bu as conditioning regimen followed by low-dose decitabine maintenance
Interventions
Cladribine combined with cytarabine and VP16 sequential with Fludarabine combined with busulifan
Eligibility Criteria
You may qualify if:
- refractory myeloid malignancies including acute myeloid leukemia (AML) or chronic myeloid leukemia in blastic crisis (CML-BC)
- HLA matched sibling，unrelated donor, or haplo-identical donor
- Patients with bone marrow blast \>5% and positive measurable disease via flowcytometry or PCR.
You may not qualify if:
- patients with active infection
- liver function damage: ALT/AST above 2X normal range; and renal function damage Scr\>160µmol/L; insufficient pulmonary function (FEV1，FVC，DLCO\<50%）and heart failure or with EF \<50%
- mental instability
- unwilling to give inform consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, 200025, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Junming Li, M.D
Department of Hematology, Rui Jin Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head, Blood & Marrow Transplantation program
Study Record Dates
First Submitted
March 18, 2019
First Posted
March 20, 2019
Study Start
August 1, 2018
Primary Completion
August 30, 2021
Study Completion
December 30, 2022
Last Updated
August 15, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share