CDIAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Chidamide, Decitabine Combined With Priming IAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2018
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 11, 2019
CompletedFirst Posted
Study publicly available on registry
June 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2021
CompletedMarch 17, 2022
March 1, 2022
3 years
June 11, 2019
March 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Remission Rate
Remission rate achieved after one-two couses induction therapy by CDIAG regimen
1 month
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.
1 year
Secondary Outcomes (2)
Adverse events in hematological system
1 month
Adverse events in other organs or systems
1 month
Study Arms (1)
CDIAG
EXPERIMENTALRelapsed or refractroy acute myeloid leukemia patients reveive chidamide, decitabine combined with priming IAG regimen treatment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Relapsed or refractory acute myeloid leukemia patients without severe complications such as active infections and bleedings; ECOG score less than 3.
You may not qualify if:
- Inablity to tolerate inducton chemotherapy; life expectancy less than 1 month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Related Publications (1)
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.
PMID: 34540696DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- accociate professor
Study Record Dates
First Submitted
June 11, 2019
First Posted
June 13, 2019
Study Start
January 1, 2018
Primary Completion
December 31, 2020
Study Completion
March 16, 2021
Last Updated
March 17, 2022
Record last verified: 2022-03