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

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ClinicalTrials.gov Identifier: NCT03985007
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Sheng-Li Xue, MD, 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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
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 : January 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985007


Contacts
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Contact: Sheng-Li Xue, M.D. +86 512 67781139 slxue@suda.edu.cn

Locations
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China, Jiangsu
The First Affliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215006
Contact: Sheng-Li Xue, M.D.    +86 512 6778 1139    slxue@suda.edu.cn   
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University

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Responsible Party: Sheng-Li Xue, MD, accociate professor, The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT03985007     History of Changes
Other Study ID Numbers: SZCDIAG
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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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, The First Affiliated Hospital of Soochow University:
chidamide
decitabine
priming regimen
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors