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

This study is currently recruiting participants.
Verified December 2012 by Chinese PLA General Hospital
Sponsor:
Collaborator:
Navy General Hospital, Beijing
Information provided by (Responsible Party):
Li Yu, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01758367
First received: December 27, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted

December 27, 2012
December 27, 2012
December 2012
December 2014   (final data collection date for primary outcome measure)
complete remission rate [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
overall survival [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Decitabine Followed by Donor Lymphocyte Infusion for Patients With Relapsed Acute Myeloblastic Leukemia(AML) After Allogeneic Stem Cell Transplantation
Not Provided

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.
Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Recurrent Adult Acute Myeloid Leukemia
Drug: Deciatbine(DAC)
Other Name: 5-aza-2'-deoxycytidine
Experimental: Decitabine+DLI
Patients with relapsed AML after Allo-HSCT will be treated with decitabine and DLI.
Intervention: Drug: Deciatbine(DAC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2016
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Li Yu, MD, PhD 86-010-55499003 chunhuiliyu@yahoo.com
Contact: Li-Xin Wang, MD, PhD 86-010-66958509 wanglixin1991@sohu.com
China
 
NCT01758367
CN301-XYK-002
Not Provided
Li Yu, Chinese PLA General Hospital
Chinese PLA General Hospital
Navy General Hospital, Beijing
Not Provided
Chinese PLA General Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP