Decitabine Combining Modified CAG Followed by HLA Haploidentical Peripheral Blood Mononuclear Cells Infusion for Elderly Patients With Acute Myeloid Leukemia(AML)

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: NCT01690507
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : February 25, 2016
Navy General Hospital, Beijing
Information provided by (Responsible Party):
Li Yu, Chinese PLA General Hospital

Brief Summary:
Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory molecules and adhesion molecules. The leukemias cells treated by decitabine will become more sensitive to the following adoptive T cell therapy.

Condition or disease Intervention/treatment Phase
MDS AML Drug: Decitabine Drug: Cytarabine Drug: aclacinomycin Drug: Granulocyte colony-stimulating factor Other: HLA haploidentical mononuclear cells infusion Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of Decitabine Combined With Modified CAG Followed by HLA Haploidentical T Cell Infusion in Treating Elderly Patients With Intermediate-high Risk Myelodysplastic Syndrome(MDS) or Acute Myeloid Leukemia(AML)
Study Start Date : November 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : January 2016

Arm Intervention/treatment
DCAG plus HLI Drug: Decitabine
20 mg/m²/day for 5 days

Drug: Cytarabine
Drug: aclacinomycin
Drug: Granulocyte colony-stimulating factor
Other Name: G-CSF

Other: HLA haploidentical mononuclear cells infusion
Other Name: DLI

Primary Outcome Measures :
  1. CR rate [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

PATIENT Inclusion Criteria:

  • Must have a diagnosis of MDS-RAEB or AML based on 2008 World Health Organization (WHO) classification of myeloid malignancies
  • Must have life expectancy >= 3 months
  • Must have the ability to observe the efficacy and events
  • Must have no accompany therapy(including steroid)
  • 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 haploidentical donor

DONOR Inclusion Criteria:

  • Must have signed the standard informed consent form; if sufficient cryopreserved cells remain from a previous donation, no additional donation or consent is required
  • Both men and women and members of all races and ethnic groups are eligible for this trial

PATIENT 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

DONOR Exclusion Criteria:

  • Must not have any underlying conditions which would contra-indicate apheresis
  • Must not be pregnant

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): NCT01690507

China, Beijing
Navy General Hospital
Beijing, Beijing, China, 100048
Chinese PLA General Hospital
Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Navy General Hospital, Beijing
Principal Investigator: Li Yu, M.D. Ph.D. Chinese PLA General Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Li Yu, Director of Department of Hematology and BMT Center, Chinese PLA General Hospital Identifier: NCT01690507     History of Changes
Other Study ID Numbers: CN301-XYK-001
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016

Keywords provided by Li Yu, Chinese PLA General Hospital:
demethylating agent

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Adjuvants, Immunologic
Antibiotics, Antineoplastic