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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01809392
Other study ID # hematology-02
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received January 18, 2013
Last updated March 10, 2013
Start date January 2013
Est. completion date December 2015

Study information

Verified date March 2013
Source The First Affiliated Hospital of Soochow University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 15
Est. completion date December 2015
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
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

Locations

Country Name City State
China First Affiliated Hospital, Soochow University Suzhou Jiangsu

Sponsors (2)

Lead Sponsor Collaborator
The First Affiliated Hospital of Soochow University Xian-Janssen Pharmaceutical Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other To assess lymphoid and myeloid chimerism post transplantation three years No
Other To determine the incidence of acute and chronic GVHD three years Yes
Other To determine the rates disease relapse, 3-year disease-free survival, and overall survival three years Yes
Other To access the frequency of FoxP3+ CD4+CD25+ lymphocytes and WT1 specific CTL before and after decitabine treatment three years Yes
Other To assess changes in WT1 gene expression and methylation patterns before and after following decitabine treatment three years No
Primary To assess the effects of decitabine on graft versus leukemia post transplant. three years Yes
Secondary To assess immunologic reconstitution after allo HSCT three years Yes
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