Back to resultsFludarabine and Cytarabine Versus High-dose Cytarabine for CBF-AML
Primary Purpose
Acute Myeloid Leukemia, Core-Binding Factor
Status
Recruiting
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 RUNX1-RUNX1T1, CBFβ-MYH11, fludarabine, cytarabine
Eligibility Criteria
Inclusion Criteria:
- Clinical and laboratory diagnosis of CBF-AML,including RUNX1-RUNX1T1 and CBF-MYH11 fusion gene rearrangement by PCR/FISH
- In status of complete remission after one to two courses of induction therapy
- Total bilirubinic acid ≤ 35μmol/L, AST/ALT<2 times abnormal level, serum creatinine < 1.5mg/ml
- Cardiac function: EF ≥ 50%
- Hydroxyurea can be used for patient with white blood cell count ≥ 50*109/L
- ECOG (Eastern Cooperative Oncology Group) score: ≤ 2
Exclusion Criteria:
- Relapsed/refractory AML
- Serious liver/ kidney dysfunction
- Cardiac function level: 2 above
- Female in pregnancy or lactation
- With serious infection diseases or other diseases
- Not obey the principle of clinical study
Sites / Locations
- Xianmin SongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fludarabine
high-dose cytarabine
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 1500mg/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
Comparing the percentage of participants with disease recurrence with two therapeutic regimen
Secondary Outcome Measures
Percentage of Participants in survival
Comparing the percentage of Participants in survival with two therapeutic regimen
Full Information
NCT ID
NCT02926586
First Posted
October 5, 2016
Last Updated
May 5, 2022
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02926586
Brief Title
Fludarabine and Cytarabine Versus High-dose Cytarabine for CBF-AML
Official Title
Fludarabine and Cytarabine Versus High-dose Cytarabine in Consolidation Treatment of Core-bing Factor Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
August 16, 2020 (Actual)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
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 core-binding factor acute myeloid leukemia
Detailed Description
The recurrence rate, relapse-free survival rate, and overall survival rate of CBF-AML patients were compared between FA and HIDAC regimens. Observe the prognostic value of factors such as c-KIT gene mutation and minimal residual disease (MRD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Core-Binding Factor
Keywords
RUNX1-RUNX1T1, CBFβ-MYH11, fludarabine, cytarabine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (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 1500mg/m2/d for 5 days intravenously.
Arm Title
high-dose cytarabine
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
Fludarabine 50 mg/m2, IV (in the vein) in combination with cytarabine 1500mg/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
Description
Comparing the percentage of participants with disease recurrence with two therapeutic regimen
Time Frame
one year
Secondary Outcome Measure Information:
Title
Percentage of Participants in survival
Description
Comparing the percentage of Participants in survival with two therapeutic regimen
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical and laboratory diagnosis of CBF-AML,including RUNX1-RUNX1T1 and CBF-MYH11 fusion gene rearrangement by PCR/FISH
In status of complete remission after one to two courses of induction therapy
Total bilirubinic acid ≤ 35μmol/L, AST/ALT<2 times abnormal level, serum creatinine < 1.5mg/ml
Cardiac function: EF ≥ 50%
Hydroxyurea can be used for patient with white blood cell count ≥ 50*109/L
ECOG (Eastern Cooperative Oncology Group) score: ≤ 2
Exclusion Criteria:
Relapsed/refractory AML
Serious liver/ kidney dysfunction
Cardiac function level: 2 above
Female in pregnancy or lactation
With serious infection diseases or other diseases
Not obey the principle of clinical study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xianmin Song, Doctor
Phone
86-21-63240090-3932
Email
shongxm@sjtu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xianmin Song, Doctor
Organizational Affiliation
Department of hematology, Shanghai General Hospital, No. 100 Haining Road, Shang
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xianmin Song
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianmin Song, Doctor
Phone
86-21-63240090-3932
Email
shongxm@sjtu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Fludarabine and Cytarabine Versus High-dose Cytarabine for CBF-AML
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