- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03882203
CLAGE Sequential With Flu-Bu Conditioning for Refractory Acute Leukemia
August 14, 2023 updated by: Jiong HU, Shanghai Jiao Tong University School of Medicine
Cladribine With Intermediate Cytarabine, G-CSF and VP16 Sequential With Fludarabine and Busulifan as Condoning Regimen for Refractory Acute Leukemia
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Shanghai, China, 200025
- Blood & Marrow Transplantation Center, RuiJin Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treatment
Patients receive the study protocol: CLAGE sequential with Flu-Bu as conditioning regimen followed by low-dose decitabine maintenance
|
Cladribine combined with cytarabine and VP16 sequential with Fludarabine combined with busulifan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
leukemia-free survival
Time Frame: 1 year
|
From enrollment to any event as relapse or death
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: 1 year
|
From enrollment to death
|
1 year
|
relapse rate
Time Frame: 1 year
|
From enrollment to documentation of relapse
|
1 year
|
non relapse mortality
Time Frame: 1 year
|
From enrollment to documentation of death without evidence of leukemia
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Junming Li, M.D, Department of Hematology, Rui Jin Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2018
Primary Completion (Actual)
August 30, 2021
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
March 18, 2019
First Submitted That Met QC Criteria
March 18, 2019
First Posted (Actual)
March 20, 2019
Study Record Updates
Last Update Posted (Actual)
August 15, 2023
Last Update Submitted That Met QC Criteria
August 14, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RJH-Ref-AL-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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