Back to resultsAML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy
Primary Purpose
Acute Myeloid Leukemia, AML1-ETO Fusion Protein Expression
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Fludarabine
Cytarabine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring acute myeloid leukemia,, AML1-ETO fusion protein,, Fludarabine,, recurrence
Eligibility Criteria
Inclusion Criteria:
- Clinical and laboratory diagnosis of AML1-ETO positive acute myeloid leukemia
- In status of complete remission after one to two courses of induction therapy with DA(Daunorubicin 60mg/m2/d for 3 days, cytarabine 100mg/m2/d for 5-7days) regimen
- ECOG (Eastern Cooperative Oncology Group) score: <2
Exclusion Criteria:
- Serious liver/ kidney dysfunction
- Cardiac function level: 2 above
- Female in pregnancy or lactation
- With serious infection diseases or other diseases
Sites / Locations
- Department of Hematology, Changhai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fludarabine
HD-Arac
Arm Description
The patients in experimental arm should receive the consolidation chemotherapy regimen with fludarabine and cytarabine. The dosage of fludarabine is 30mg/m2/d for 5 days intravenously and cytarabine is 1.4g/m2/d for 5 days intravenously.
The patients in control arm should receive the consolidation chemotherapy regimen with high-dose cytarabine. The dosage of cytarabine is 2000mg/m2/12h for 3 days (1,3,5) intravenously.
Outcomes
Primary Outcome Measures
Percentage of participants with disease recurrence
Secondary Outcome Measures
Percentage of Participants in survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02024308
Brief Title
AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy
Official Title
A Randomized Comparison of Fludarabine in Combination With Cytarabine Versus High -Dose Cytarabine in Post-remission Therapy for AML1-ETO Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to determine whether Fludarabine in combination with cytarabine is more effective than high-dose cytarabine in post-remission therapy for patients with AML1-ETO acute myeloid leukemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, AML1-ETO Fusion Protein Expression
Keywords
acute myeloid leukemia,, AML1-ETO fusion protein,, Fludarabine,, recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fludarabine
Arm Type
Experimental
Arm Description
The patients in experimental arm should receive the consolidation chemotherapy regimen with fludarabine and cytarabine. The dosage of fludarabine is 30mg/m2/d for 5 days intravenously and cytarabine is 1.4g/m2/d for 5 days intravenously.
Arm Title
HD-Arac
Arm Type
Active Comparator
Arm Description
The patients in control arm should receive the consolidation chemotherapy regimen with high-dose cytarabine. The dosage of cytarabine is 2000mg/m2/12h for 3 days (1,3,5) intravenously.
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Other Intervention Name(s)
Fludara
Intervention Description
50 mg/m2, IV (in the vein) in combination with cytarabine 1.4mg/m2/d for 5 days with each cycle of 28 days. Number of cycles: 4
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
Cytosar
Intervention Description
2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4
Primary Outcome Measure Information:
Title
Percentage of participants with disease recurrence
Time Frame
one year
Secondary Outcome Measure Information:
Title
Percentage of Participants in survival
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical and laboratory diagnosis of AML1-ETO positive acute myeloid leukemia
In status of complete remission after one to two courses of induction therapy with DA(Daunorubicin 60mg/m2/d for 3 days, cytarabine 100mg/m2/d for 5-7days) regimen
ECOG (Eastern Cooperative Oncology Group) score: <2
Exclusion Criteria:
Serious liver/ kidney dysfunction
Cardiac function level: 2 above
Female in pregnancy or lactation
With serious infection diseases or other diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xianmin Song, Doctor
Phone
83-21-31161285
Email
shongxm@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xianmin Song, Doctor
Organizational Affiliation
Department of Hematology, Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematology, Changhai Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianmin Song
Phone
86-21-31161285
Email
shongxm@gmail.com
First Name & Middle Initial & Last Name & Degree
Xianmin Song
12. IPD Sharing Statement
Learn more about this trial
AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy
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