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

This study is currently recruiting participants.
Verified December 2012 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:
NCT01758367
First received: December 27, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Recurrent Adult Acute Myeloid Leukemia
 Drug: Deciatbine(DAC)
 Phase 1
Phase 2

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

Resource links provided by NLM:

Drug Information available for: Decitabine
U.S. FDA Resources

Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • complete remission rate [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Decitabine+DLI
Patients with relapsed AML after Allo-HSCT will be treated with decitabine and DLI.
 Drug: Deciatbine(DAC)
Other Name: 5-aza-2'-deoxycytidine

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758367

Contacts
Contact: Li Yu, MD, PhD 86-010-55499003 chunhuiliyu@yahoo.com
Contact: Li-Xin Wang, MD, PhD 86-010-66958509 wanglixin1991@sohu.com

Locations
China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Li Yu, MD, PhD     86-010-55499003     chunhuiliyu@yahoo.com    
Contact: Li-Xin Wang, MD, PhD     86-010-66958509     wanglixin1991@sohu.com    
Principal Investigator: Li Yu, MD, PhD            
Sub-Investigator: Li-Xin Wang, MD, PhD            
Sponsors and Collaborators
Chinese PLA General Hospital
Navy General Hospital, Beijing
  More Information

No publications provided

Responsible Party: Li Yu, Director of Department of Hematology, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01758367     History of Changes
Other Study ID Numbers: CN301-XYK-002
Study First Received: December 27, 2012
Last Updated: December 27, 2012
Health Authority: China: Ethics Committee

Keywords provided by Chinese PLA General Hospital:
demethylating agent
immunogenicity
decitabine(DAC)
donor lymphocyte infusion(DLI)
AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Decitabine
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013