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

Phase 2

Completed

• Conditions: Acute Myeloid Leukemia, Relapsed, Adult
• Interventions: Drug: CDIAG regimen

• Registration Number: NCT03985007
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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 available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-06-11
• Study First Posted: 2019-06-13
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-16
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CDIAG	CDIAG regimen	Relapsed or refractroy acute myeloid leukemia patients reveive chidamide, decitabine combined with priming IAG regimen treatment.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The First Affliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China