Trial record 8 of 16 for:    WAGR

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Xian-Janssen Pharmaceutical Ltd.
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier:
NCT01809392
First received: January 18, 2013
Last updated: March 10, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Acute Myelocytic Leukemia
Myelodysplastic Syndromes
Drug: decitabine
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital of Soochow University:

Primary Outcome Measures:
  • To assess the effects of decitabine on graft versus leukemia post transplant. [ Time Frame: three years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess immunologic reconstitution after allo HSCT [ Time Frame: three years ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • To assess lymphoid and myeloid chimerism post transplantation [ Time Frame: three years ] [ Designated as safety issue: No ]
  • To determine the incidence of acute and chronic GVHD [ Time Frame: three years ] [ Designated as safety issue: Yes ]
  • To determine the rates disease relapse, 3-year disease-free survival, and overall survival [ Time Frame: three years ] [ Designated as safety issue: Yes ]
  • To access the frequency of FoxP3+ CD4+CD25+ lymphocytes and WT1 specific CTL before and after decitabine treatment [ Time Frame: three years ] [ Designated as safety issue: Yes ]
  • To assess changes in WT1 gene expression and methylation patterns before and after following decitabine treatment [ Time Frame: three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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
No Intervention: no decitabine

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01809392

Locations
China, Jiangsu
First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, China, 215000
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
Xian-Janssen Pharmaceutical Ltd.
Investigators
Study Director: Fu chengcheng, Phd First Affiliated Hospital, Soochow University
  More Information

No publications provided

Responsible Party: The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT01809392     History of Changes
Other Study ID Numbers: hematology-02
Study First Received: January 18, 2013
Last Updated: March 10, 2013
Health Authority: China: Ethics Committee

Keywords provided by The First Affiliated Hospital of Soochow University:
Decitabine
hematopoietic stem cell transplant
Wilms' tumor 1
cytolytic T lymphocyte
Regulatory T cell

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 23, 2014