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
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia, Relapsed, Adult||Drug: CDIAG regimen||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Remission Rate [ Time Frame: 1 month ]Remission rate achieved after one-two couses induction therapy by CDIAG regimen
- 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.
- Adverse events in hematological system [ Time Frame: 1 month ]Record of adverse events in hematological system during and after CDIAG regimen induction
- 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
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
|Contact: Sheng-Li Xue, M.D.||+86 512 firstname.lastname@example.org|
|The First Affliated Hospital of Soochow University||Recruiting|
|Suzhou, Jiangsu, China, 215006|
|Contact: Sheng-Li Xue, M.D. +86 512 6778 1139 email@example.com|