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Phase 1/Phase 2
18 Years
60 Years
Open (Enrolling)
Recurrent Adult Acute Myeloid Leukemia

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Trial Information

Inclusion Criteria:

- Age 18 - 60 years

- Histologically or cytologically documented relapse of acute myeloid leukemia after a
stem cell transplant

- Must have the ability to observe the efficacy and events

- Patient must have ability to understand and willingness to provide written informed
consent prior to participation in the study and any related procedures being

- Must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 3

- Must have suitable donor

Exclusion Criteria:

- Must not have an advanced malignant hepatic tumor

- Must not receive any other forms of chemotherapy after cell infusion during the
treatment protocol

- Must not be receiving any other investigational agents within 14 days of first dose
of study drug

- Must not have uncontrolled intercurrent illness including ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, or
psychiatric illness/social situations that would limit compliance with study

- Must not be pregnant or breastfeeding; pregnant women are excluded from this study
because decitabine is a Category D agent with the potential for teratogenic or
abortifacient effects; because there is an unknown but potential risk for adverse
events in nursing infants secondary to treatment of the mother with decitabine,
breastfeeding should be discontinued if the mother is treated with decitabine; these
potential risks may also apply to other agents used in this study

- Must not have a history of allergic reactions attributed to compounds of similar
chemical or biologic composition to decitabine or other agents used in the study

- Must not have a known or suspected hypersensitivity to decitabine

- Must not be human immunodeficiency virus (HIV)-positive and on combination
antiretroviral therapy; these patients are ineligible because of the potential for
pharmacokinetic interactions with decitabine; in addition, these patients are at
increased risk of lethal infections when treated with marrow-suppressive therapy;
appropriate studies will be undertaken in patients receiving combination
antiretroviral therapy when indicated

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

complete remission rate

Outcome Time Frame:

4 months

Safety Issue:



China: Ethics Committee

Study ID:




Start Date:

December 2012

Completion Date:

December 2016

Related Keywords:

  • Recurrent Adult Acute Myeloid Leukemia
  • demethylating agent
  • immunogenicity
  • decitabine(DAC)
  • donor lymphocyte infusion(DLI)
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid