Skip to main content
OpenTrials
Completed

NCT Number: NCT03985007

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myeloid Leukemia, Relapsed, Adult Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CDIAG regimen

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Collaborators

  • Jining Medical University

Registry information

Official study title

Chidamide, Decitabine Combined With Priming IAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jun 13, 2019
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.