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Decitabine Followed by Donor Lymphocyte Infusion for Patients With Relapsed Acute Myeloblastic Leukemia(AML) After Allogeneic Stem Cell Transplantation

Primary Purpose

Recurrent Adult Acute Myeloid Leukemia

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Deciatbine(DAC)
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Adult Acute Myeloid Leukemia focused on measuring demethylating agent, immunogenicity, decitabine(DAC), donor lymphocyte infusion(DLI), AML

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 - 60 years
  • Histologically or cytologically documented relapse of acute myeloid leukemia after a stem cell transplant
  • Must have the ability to observe the efficacy and events
  • 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 suitable donor

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

Sites / Locations

  • Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Decitabine+DLI

Arm Description

Patients with relapsed AML after Allo-HSCT will be treated with decitabine and DLI.

Outcomes

Primary Outcome Measures

complete remission rate

Secondary Outcome Measures

overall survival

Full Information

First Posted
December 27, 2012
Last Updated
August 29, 2016
Sponsor
Chinese PLA General Hospital
Collaborators
Navy General Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT01758367
Brief Title
Decitabine Followed by Donor Lymphocyte Infusion for Patients With Relapsed Acute Myeloblastic Leukemia(AML) After Allogeneic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
Collaborators
Navy General Hospital, Beijing

4. Oversight

5. Study Description

Brief Summary
Decitabine can up-regulate a series of immune associated proteins, including cancer testis antigens (CTA), major histocompatibility complex (MHC), co-stimulatory molecules and adhesion molecules, which suggests a potential benefit for a following adoptive T cell therapy. In addition, decitabine induce FOXP3 expression in CD4+ T cells and convert CD4+ T cells into T regulatory cells(Tregs). As a result, Graft versus host disease(GVHD) can be reduced by treatment of decitabine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Adult Acute Myeloid Leukemia
Keywords
demethylating agent, immunogenicity, decitabine(DAC), donor lymphocyte infusion(DLI), AML

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Decitabine+DLI
Arm Type
Experimental
Arm Description
Patients with relapsed AML after Allo-HSCT will be treated with decitabine and DLI.
Intervention Type
Drug
Intervention Name(s)
Deciatbine(DAC)
Other Intervention Name(s)
5-aza-2'-deoxycytidine
Primary Outcome Measure Information:
Title
complete remission rate
Time Frame
4 months
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
3 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 - 60 years Histologically or cytologically documented relapse of acute myeloid leukemia after a stem cell transplant Must have the ability to observe the efficacy and events 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 suitable donor 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Yu, MD, PhD
Phone
86-010-55499003
Email
chunhuiliyu@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li-Xin Wang, MD, PhD
Phone
86-010-66958509
Email
wanglixin1991@sohu.com
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yu, MD, PhD
Phone
86-010-55499003
Email
chunhuiliyu@yahoo.com
First Name & Middle Initial & Last Name & Degree
Li-Xin Wang, MD, PhD
Phone
86-010-66958509
Email
wanglixin1991@sohu.com
First Name & Middle Initial & Last Name & Degree
Li Yu, MD, PhD
First Name & Middle Initial & Last Name & Degree
Li-Xin Wang, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Decitabine Followed by Donor Lymphocyte Infusion for Patients With Relapsed Acute Myeloblastic Leukemia(AML) After Allogeneic Stem Cell Transplantation

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