This trial is active, not recruiting.

Conditions acute myelocytic leukemia, myelodysplastic syndromes
Treatment decitabine
Phase phase 2/phase 3
Sponsor The First Affiliated Hospital of Soochow University
Collaborator Xian-Janssen Pharmaceutical Ltd.
Start date January 2013
End date December 2013
Trial size 15 participants
Trial identifier NCT01809392, hematology-02


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
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)

Primary Outcomes

To assess the effects of decitabine on graft versus leukemia post transplant.
time frame: three years

Secondary Outcomes

To assess immunologic reconstitution after allo HSCT
time frame: three years

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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.

Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by The First Affiliated Hospital of Soochow University.