- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01809392
Decitabine Augments for Post Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
March 10, 2013 updated by: The First Affiliated Hospital of Soochow University
Allo - hematopoietic stem cell transplantation is currently the only way to cure myelodysplastic syndrome /acute leukemia .
The existing experimental results showed that decitabine and 5-azacytidine up-regulated the expression of tumor Ags on leukemic blasts in vitro and expanded the numbers of immunomodulatory T regulatory cells in animal models.
Reasoning that decitabine might selectively augment a graft versus leukemia effect, the investigators used decitabine administration after allogeneic stem cell transplantation to studied the immunologic sequelae.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
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Suzhou, Jiangsu, China, 215000
- First Affiliated Hospital, SooChow University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed AML in complete or partial remission or MDS using WHO classification undergoing alloHSCT
- High resolution typing HLA-matched related or unrelated donor. Donors may be mismatched at single antigen at HLA-A, -B or -DR locus plus possible single antigen mismatch at HLA-C according to institution guidelines. Two-antigen mismatch at a single locus is not allowed.
- Age ≥ 18
- creatinine < 1.5 times the institutional ULN or creatinine clearance (calculated by the Cockroft and Gault method) ≥ 30 mL/min
- bilirubin < 1.5 times the institutional ULN
- AST, ALT and alkaline phosphatase < 2.5 times the institutional ULN.
Exclusion Criteria:
- History of previous alloHSCT prior to the current alloHSCT.
- Persistent AML or MDS after alloHSCT.
- Positive serology for HIV.
- Pregnancy or nursing.
- Other cancers less than or equal to 2 years prior study entry except: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, prostate cancer stage T1a or T1b.
- Uncontrolled active infections requiring intravenous antibiotics. Clinically significant systemic illness (e.g. serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), which, in the judgment of the Principal or Associate Investigator would compromise the patient's ability to tolerate protocol therapy.
- Known or suspected hypersensitivity to decitabine.
- Patients may not be receiving any other investigational agents.
- General or specific changes in patient's condition that render the patient unacceptable for further treatment in judgment of the investigators.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: decitabine
36 mg/m2 on day 42 after transplantation and administered daily for 5 consecutive days every 28 days for up to a total of 10 cycles
|
36 mg/m2 on day 42 after transplantation and administered daily for 5 consecutive days every 28 days for up to a total of 10 cycles
|
No Intervention: no decitabine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the effects of decitabine on graft versus leukemia post transplant.
Time Frame: three years
|
three years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess immunologic reconstitution after allo HSCT
Time Frame: three years
|
three years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess lymphoid and myeloid chimerism post transplantation
Time Frame: three years
|
three years
|
To determine the incidence of acute and chronic GVHD
Time Frame: three years
|
three years
|
To determine the rates disease relapse, 3-year disease-free survival, and overall survival
Time Frame: three years
|
three years
|
To access the frequency of FoxP3+ CD4+CD25+ lymphocytes and WT1 specific CTL before and after decitabine treatment
Time Frame: three years
|
three years
|
To assess changes in WT1 gene expression and methylation patterns before and after following decitabine treatment
Time Frame: three years
|
three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Fu chengcheng, Phd, First Affiliated Hospital, SooChow University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
January 18, 2013
First Submitted That Met QC Criteria
March 10, 2013
First Posted (Estimate)
March 12, 2013
Study Record Updates
Last Update Posted (Estimate)
March 12, 2013
Last Update Submitted That Met QC Criteria
March 10, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Syndrome
- Myelodysplastic Syndromes
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Preleukemia
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Decitabine
Other Study ID Numbers
- hematology-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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