Status:
UNKNOWN
Decitabine Augments for Post Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborating Sponsors:
Xian-Janssen Pharmaceutical Ltd.
Conditions:
Acute Myelocytic Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
PHASE3
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 u...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01809392
Start Date
January 1 2013
End Date
December 1 2015
Last Update
March 12 2013
Active Locations (1)
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1
First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, China, 215000