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Decitabine Followed by Donor Lymphocyte Infusion for Patients With Relapsed Acute Myeloblastic Leukemia(AML) After Allogeneic Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01758367
Recruitment Status : Unknown
Verified August 2016 by Li Yu, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : January 1, 2013
Last Update Posted : August 31, 2016
Navy General Hospital, Beijing
Information provided by (Responsible Party):
Li Yu, Chinese PLA General Hospital

Brief Summary:
Decitabine can up-regulate a series of immune associated proteins, including cancer testis antigens (CTA), major histocompatibility complex (MHC), co-stimulatory molecules and adhesion molecules, which suggests a potential benefit for a following adoptive T cell therapy. In addition, decitabine induce FOXP3 expression in CD4+ T cells and convert CD4+ T cells into T regulatory cells(Tregs). As a result, Graft versus host disease(GVHD) can be reduced by treatment of decitabine.

Condition or disease Intervention/treatment Phase
Recurrent Adult Acute Myeloid Leukemia Drug: Deciatbine(DAC) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018

Arm Intervention/treatment
Experimental: Decitabine+DLI
Patients with relapsed AML after Allo-HSCT will be treated with decitabine and DLI.
Drug: Deciatbine(DAC)
Other Name: 5-aza-2'-deoxycytidine

Primary Outcome Measures :
  1. complete remission rate [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 3 Years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 performed
  • 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 requirements
  • 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

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 identifier (NCT number): NCT01758367

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Contact: Li Yu, MD, PhD 86-010-55499003
Contact: Li-Xin Wang, MD, PhD 86-010-66958509

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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Li Yu, MD, PhD    86-010-55499003   
Contact: Li-Xin Wang, MD, PhD    86-010-66958509   
Principal Investigator: Li Yu, MD, PhD         
Sub-Investigator: Li-Xin Wang, MD, PhD         
Sponsors and Collaborators
Chinese PLA General Hospital
Navy General Hospital, Beijing

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Responsible Party: Li Yu, Director of Department of Hematology, Chinese PLA General Hospital Identifier: NCT01758367     History of Changes
Other Study ID Numbers: CN301-XYK-002
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Keywords provided by Li Yu, Chinese PLA General Hospital:
demethylating agent
donor lymphocyte infusion(DLI)
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors