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

• Sponsor: The First Affiliated Hospital of Soochow University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03985007
• Collaborator: Jining Medical University (Other)
• Enrollment: 40
• Location: 1
• Arm: 1
• Actual Duration (Months): 38.4
• Patients Per Site Per Month: 1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia, Relapsed, Adult	Drug: CDIAG regimen	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Chidamide, Decitabine Combined With Priming IAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Mar 16, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: CDIAG Relapsed or refractroy acute myeloid leukemia patients reveive chidamide, decitabine combined with priming IAG regimen treatment.

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.

Outcome Measures

Primary Outcome Measures

1. Remission Rate [1 month]

   Remission rate achieved after one-two couses induction therapy by CDIAG regimen

2. 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

1. Adverse events in hematological system [1 month]

   Record of adverse events in hematological system during and after CDIAG regimen induction

2. Adverse events in other organs or systems [1 month]

   Record of adverse events in other organs or systmes during and after CDIAG regimen induction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affliated Hospital of Soochow University	Suzhou	Jiangsu	China	215006

Sponsors and Collaborators

• The First Affiliated Hospital of Soochow University
• Jining Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sheng-Li Xue, MD, accociate professor, The First Affiliated Hospital of Soochow University
• ClinicalTrials.gov Identifier: NCT03985007
• Other Study ID Numbers: SZCDIAG
• First Posted: Jun 13, 2019
• Last Update Posted: Mar 17, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Sheng-Li Xue, MD, accociate professor, The First Affiliated Hospital of Soochow University: chidamide; decitabine; priming regimen
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Mar 17, 2022