Decitabine Followed by Donor Lymphocyte Infusion for Patients With Relapsed Acute Myeloblastic Leukemia(AML) After Allogeneic Stem Cell Transplantation
NCT ID: NCT01758367
Last Updated: 2016-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2012-12-31
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Decitabine+DLI
Patients with relapsed AML after Allo-HSCT will be treated with decitabine and DLI.
Deciatbine(DAC)
Interventions
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Deciatbine(DAC)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
60 Years
ALL
No
Sponsors
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Navy General Hospital, Beijing
OTHER
Chinese PLA General Hospital
OTHER
Responsible Party
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Li Yu
Director of Department of Hematology
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CN301-XYK-002
Identifier Type: -
Identifier Source: org_study_id
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