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

Chinese PLA General Hospital (301 Hospital)

Status and phase

Completed

Phase 2

Phase 1

Conditions

AML

MDS

Treatments

Other: HLA haploidentical mononuclear cells infusion

Drug: Decitabine

Drug: Cytarabine

Drug: aclacinomycin

Drug: Granulocyte colony-stimulating factor

Study type

Interventional

Funder types

Other

Identifiers

NCT01690507

CN301-XYK-001

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

55 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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: