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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 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:
NCT01690507
First received: September 19, 2012
Last updated: October 13, 2014
Last verified: October 2014

September 19, 2012
October 13, 2014
November 2012
December 2014   (final data collection date for primary outcome measure)
CR rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • event free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01690507 on ClinicalTrials.gov Archive Site
overall survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • complete remission rate [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • overall response rate [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Decitabine Combining Modified CAG Followed by HLA Haploidentical Peripheral Blood Mononuclear Cells Infusion for Elderly Patients With Acute Myeloid Leukemia(AML)
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)

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • MDS
  • AML
  • 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
Experimental: DCAG plus DLI
Patient will be treated with decitabine and modified CAG regimen followed by HLA haploidentical peripheral mononuclear blood cells infusion
Interventions:
  • Drug: Decitabine
  • Drug: Cytarabine
  • Drug: aclacinomycin
  • Drug: Granulocyte colony-stimulating factor
  • Other: HLA haploidentical mononuclear cells infusion
Not Provided

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

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
Both
55 Years to 75 Years
No
Contact: Li Yu, M.D. Ph.D. 86-010-55499003 chunhuiliyu@yahoo.com
Contact: Li-Xin Wang, M.D. Ph.D. 86-010-66958509 wanglixin1991@sohu.com
China
 
NCT01690507
CN301-XYK-001
No
Li Yu, Chinese PLA General Hospital
Chinese PLA General Hospital
Navy General Hospital, Beijing
Principal Investigator: Li Yu, M.D. Ph.D. Chinese PLA General Hospital
Chinese PLA General Hospital
October 2014

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