Decitabine Augments for Post Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Myelodysplastic Syndromes Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01809392
• Other study ID #: hematology-02
• 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

Related Conditions & MeSH terms

• Acute Myelocytic Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia

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