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）
1 other identifier
interventional
29
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2012
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2012
CompletedFirst Posted
Study publicly available on registry
September 21, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFebruary 25, 2016
February 1, 2016
2.5 years
September 19, 2012
February 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CR rate
3 months
Secondary Outcomes (1)
overall survival
2 years
Study Arms (1)
DCAG plus HLI
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- Must not have any underlying conditions which would contra-indicate apheresis
- Must not be pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese PLA General Hospitallead
- Navy General Hospital, Beijingcollaborator
Study Sites (2)
Navy General Hospital
Beijing, Beijing Municipality, 100048, China
Chinese PLA General Hospital
Beijing, 100853, China
Related Publications (1)
Jing Y, Jin X, Wang L, Dou L, Wang Q, Yao Y, Lian S, Zhou J, Zhu H, Yao Z, Gao L, Wang L, Li Y, Bai X, Fang M, Yu L. Decitabine-based chemotherapy followed by haploidentical lymphocyte infusion improves the effectiveness in elderly patients with acute myeloid leukemia. Oncotarget. 2016 Aug 10;8(32):53654-53663. doi: 10.18632/oncotarget.11183. eCollection 2017 Aug 8.
PMID: 28881839DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li Yu, M.D. Ph.D.
Chinese PLA General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Hematology and BMT Center
Study Record Dates
First Submitted
September 19, 2012
First Posted
September 21, 2012
Study Start
November 1, 2012
Primary Completion
May 1, 2015
Study Completion
January 1, 2016
Last Updated
February 25, 2016
Record last verified: 2016-02