Back to resultsCDIAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Primary Purpose
Acute Myeloid Leukemia, Relapsed, Adult
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CDIAG regimen
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia, Relapsed, Adult focused on measuring chidamide, decitabine, priming regimen
Eligibility Criteria
Inclusion Criteria:
- Relapsed or refractory acute myeloid leukemia patients without severe complications such as active infections and bleedings; ECOG score less than 3.
Exclusion Criteria:
- Inablity to tolerate inducton chemotherapy; life expectancy less than 1 month
Sites / Locations
- The First Affliated Hospital of Soochow University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CDIAG
Arm Description
Relapsed or refractroy acute myeloid leukemia patients reveive chidamide, decitabine combined with priming IAG regimen treatment.
Outcomes
Primary Outcome Measures
Remission Rate
Remission rate achieved after one-two couses induction therapy by CDIAG regimen
Overall survial
It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Secondary Outcome Measures
Adverse events in hematological system
Record of adverse events in hematological system during and after CDIAG regimen induction
Adverse events in other organs or systems
Record of adverse events in other organs or systmes during and after CDIAG regimen induction
Full Information
NCT ID
NCT03985007
First Posted
June 11, 2019
Last Updated
March 16, 2022
Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
Jining Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03985007
Brief Title
CDIAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Official Title
Chidamide, Decitabine Combined With Priming IAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
March 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
Jining Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This study is to investigate the therapeutic efficacy and side effect of chidamide, decitabine combined with priming IAG regimen for relapsed or refractroy 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, Relapsed, Adult
Keywords
chidamide, decitabine, priming regimen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CDIAG
Arm Type
Experimental
Arm Description
Relapsed or refractroy acute myeloid leukemia patients reveive chidamide, decitabine combined with priming IAG regimen treatment.
Intervention Type
Drug
Intervention Name(s)
CDIAG regimen
Intervention Description
Chidamide 30mg orally twice every week for 2 weeks on days 1, 4, 8, 11, decitabine 20mg/m2 intravenously daily for 5 days (d1-d5) and IAG regimen (cytarabine, 10 mg/m2 subcutaneously every 12 h on days 4-17; idarubicin, 5mg intravenously every other day on days 4, 6, 8, 10, 12, 14; and concurrent granulocyte colony-stimulating factor, 200mg/m2/day subcutaneously daily on days 3-17.
Primary Outcome Measure Information:
Title
Remission Rate
Description
Remission rate achieved after one-two couses induction therapy by CDIAG regimen
Time Frame
1 month
Title
Overall survial
Description
It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse events in hematological system
Description
Record of adverse events in hematological system during and after CDIAG regimen induction
Time Frame
1 month
Title
Adverse events in other organs or systems
Description
Record of adverse events in other organs or systmes during and after CDIAG regimen induction
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Relapsed or refractory acute myeloid leukemia patients without severe complications such as active infections and bleedings; ECOG score less than 3.
Exclusion Criteria:
Inablity to tolerate inducton chemotherapy; life expectancy less than 1 month
Facility Information:
Facility Name
The First Affliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34540696
Citation
Yin J, Wan CL, Zhang L, Zhang H, Bai L, Zhou HX, Xu MZ, Chen LY, Qian CS, Qiu HY, Chen SN, Tang XW, Wu DP, Zhang YM, Sun AN, Xue SL. A Phase II Trial of the Double Epigenetic Priming Regimen Including Chidamide and Decitabine for Relapsed/Refractory Acute Myeloid Leukemia. Front Oncol. 2021 Sep 3;11:726926. doi: 10.3389/fonc.2021.726926. eCollection 2021.
Results Reference
derived
Learn more about this trial
CDIAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
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