Decitabine Based Chemotherapy Followed by Haploidentical Lymphocyte Infusion for Elderly Patients With AML

June 6, 2019 updated by: Li-Xin Wang, Chinese PLA General Hospital
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.We proposed a hypothesis that decitabine-based chemotherapy acts in synergestic with haploidentical lymphocyte infusion in eliciting leukemia specific cytotoxic lymphocyte(CTL) and diminishing leukemic cells.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100048
        • Navy General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have a diagnosis of 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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DCAG plus HLI
Patient will be treated with decitabine and modified CAG regimen followed by HLA haploidentical peripheral mononuclear blood cells infusion.
Drug: Decitabine 20 mg/m²/day for 5 days
Other Names:
  • Cytarabine
  • aclacinomycin
Experimental: DCAG
Patient will be treated with decitabine combining modified CAG regimen without other treatments.
Drug: Decitabine 20 mg/m²/day for 5 days
Other Names:
  • Cytarabine
  • aclacinomycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complete remission(CR) rate
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Collaborators

Navy General Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

January 20, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 25, 2016

Study Record Updates

Last Update Posted (Actual)

June 10, 2019

Last Update Submitted That Met QC Criteria

June 6, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChinaNGH-H001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on AML

Clinical Trials on Decitabine 20 mg/m²/day for 5 days

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe