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出境医 / 临床实验 / CDIAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

CDIAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

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

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia, Relapsed, Adult Drug: CDIAG regimen Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chidamide, Decitabine Combined With Priming IAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: CDIAG
Relapsed or refractroy acute myeloid leukemia patients reveive chidamide, decitabine combined with priming IAG regimen treatment.
 Drug: CDIAG regimen
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.
Outcome Measures
Primary Outcome Measures :
  1. Remission Rate [ Time Frame: 1 month ]
    Remission rate achieved after one-two couses induction therapy by CDIAG regimen

  2. Overall survial [ Time Frame: 1 year ]
    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 :
  1. Adverse events in hematological system [ Time Frame: 1 month ]
    Record of adverse events in hematological system during and after CDIAG regimen induction

  2. Adverse events in other organs or systems [ Time Frame: 1 month ]
    Record of adverse events in other organs or systmes during and after CDIAG regimen induction


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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China, Jiangsu
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
Jining Medical University
Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 13, 2019
Last Update Posted Date February 3, 2021
Actual Study Start Date  ICMJE January 1, 2018
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Remission Rate [ Time Frame: 1 month ]
    Remission rate achieved after one-two couses induction therapy by CDIAG regimen
  • Overall survial [ Time Frame: 1 year ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Adverse events in hematological system [ Time Frame: 1 month ]
    Record of adverse events in hematological system during and after CDIAG regimen induction
  • Adverse events in other organs or systems [ Time Frame: 1 month ]
    Record of adverse events in other organs or systmes during and after CDIAG regimen induction
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CDIAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Official Title  ICMJE Chidamide, Decitabine Combined With Priming IAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia, Relapsed, Adult
Intervention  ICMJE Drug: CDIAG regimen
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.
Study Arms  ICMJE Experimental: CDIAG
Relapsed or refractroy acute myeloid leukemia patients reveive chidamide, decitabine combined with priming IAG regimen treatment.
Intervention: Drug: CDIAG regimen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 1, 2021) 		40
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2019) 		41
Estimated Study Completion Date  ICMJE December 31, 2021
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03985007
Other Study ID Numbers  ICMJE SZCDIAG
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University
Study Sponsor  ICMJE The First Affiliated Hospital of Soochow University
Collaborators  ICMJE Jining Medical University
Investigators  ICMJE Not Provided
PRS Account The First Affiliated Hospital of Soochow University
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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