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

AML Clinical Trial

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）

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690507
• Other study ID #: CN301-XYK-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 19, 2012
• Last updated: February 23, 2016
• Start date: November 2012
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• AML
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• MDS

Intervention

Drug:
• Decitabine
20 mg/m²/day for 5 days
• Cytarabine

• aclacinomycin

• Granulocyte colony-stimulating factor

Other:
• HLA haploidentical mononuclear cells infusion

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing
China	Navy General Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Navy General Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CR rate		3 months	Yes
Secondary	overall survival		2 years	Yes