Back to resultsDecitabine Augments for Post Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Primary Purpose
Acute Myelocytic Leukemia, Myelodysplastic Syndromes
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
decitabine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myelocytic Leukemia focused on measuring Decitabine, hematopoietic stem cell transplant, Wilms' tumor 1, cytolytic T lymphocyte, Regulatory T cell
Eligibility Criteria
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.
Sites / Locations
- First Affiliated Hospital, Soochow University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
decitabine
no decitabine
Arm Description
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
Outcomes
Primary Outcome Measures
To assess the effects of decitabine on graft versus leukemia post transplant.
Secondary Outcome Measures
To assess immunologic reconstitution after allo HSCT
Full Information
NCT ID
NCT01809392
First Posted
January 18, 2013
Last Updated
March 10, 2013
Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
Xian-Janssen Pharmaceutical Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01809392
Brief Title
Decitabine Augments for Post Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
Xian-Janssen Pharmaceutical Ltd.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelocytic Leukemia, Myelodysplastic Syndromes
Keywords
Decitabine, hematopoietic stem cell transplant, Wilms' tumor 1, cytolytic T lymphocyte, Regulatory T cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
decitabine
Arm Type
Experimental
Arm Description
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
Arm Title
no decitabine
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
decitabine
Intervention Description
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
Primary Outcome Measure Information:
Title
To assess the effects of decitabine on graft versus leukemia post transplant.
Time Frame
three years
Secondary Outcome Measure Information:
Title
To assess immunologic reconstitution after allo HSCT
Time Frame
three years
Other Pre-specified Outcome Measures:
Title
To assess lymphoid and myeloid chimerism post transplantation
Time Frame
three years
Title
To determine the incidence of acute and chronic GVHD
Time Frame
three years
Title
To determine the rates disease relapse, 3-year disease-free survival, and overall survival
Time Frame
three years
Title
To access the frequency of FoxP3+ CD4+CD25+ lymphocytes and WT1 specific CTL before and after decitabine treatment
Time Frame
three years
Title
To assess changes in WT1 gene expression and methylation patterns before and after following decitabine treatment
Time Frame
three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fu chengcheng, Phd
Organizational Affiliation
First Affiliated Hospital, Soochow University
Official's Role
Study Director
Facility Information:
Facility Name
First Affiliated Hospital, Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Decitabine Augments for Post Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
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