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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03985007

Enrollment

Registered

2019-06-13

Start date

2018-01-01

Completion date

2021-03-16

Last updated

2022-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Relapsed, Adult

Keywords

chidamide, decitabine, priming regimen

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

Interventions

DRUGCDIAG 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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Remission Rate	1 month	Remission rate achieved after one-two couses induction therapy by CDIAG regimen
Overall survial	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

Measure	Time frame	Description
Adverse events in hematological system	1 month	Record of adverse events in hematological system during and after CDIAG regimen induction
Adverse events in other organs or systems	1 month	Record of adverse events in other organs or systmes during and after CDIAG regimen induction

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026