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

Acute Myeloid Leukemia, Relapsed, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03985007
• Other study ID #: SZCDIAG
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2018
• Est. completion date: March 16, 2021

Study information

• Verified date: March 2022
• Source: The First Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 16, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia, Relapsed, Adult
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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.

Locations

Country	Name	City	State
China	The First Affliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University	Jining Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission Rate	Remission rate achieved after one-two couses induction therapy by CDIAG regimen	1 month
Primary	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	Adverse events in hematological system	Record of adverse events in hematological system during and after CDIAG regimen induction	1 month
Secondary	Adverse events in other organs or systems	Record of adverse events in other organs or systmes during and after CDIAG regimen induction	1 month