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

NCT01809392 | Unknown Phase 2

• 1 other identifier: hematology-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Acute Myelocytic Leukemia; Myelodysplastic Syndromes

Keywords

Decitabine; hematopoietic stem cell transplant; Wilms' tumor 1; cytolytic T lymphocyte; Regulatory T cell

Outcome Measures

Primary Outcomes (1)

• To assess the effects of decitabine on graft versus leukemia post transplant.

  three years

Secondary Outcomes (1)

• To assess immunologic reconstitution after allo HSCT

  three years

Other Outcomes (5)

• To assess lymphoid and myeloid chimerism post transplantation

  three years

• To determine the incidence of acute and chronic GVHD

  three years

• To determine the rates disease relapse, 3-year disease-free survival, and overall survival

  three years

Study Arms (2)

decitabine

EXPERIMENTAL

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

no decitabine

NO INTERVENTION

Interventions

decitabine DRUG

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

decitabine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• Xian-Janssen Pharmaceutical Ltd.: collaborator

Study Sites (1)

First Affiliated Hospital, Soochow University

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Wilms Tumor

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Fu chengcheng, Phd

  First Affiliated Hospital, Soochow University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2013
• First Posted: March 12, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2015
• Last Updated: March 12, 2013

Record last verified: 2013-03

Locations

CN (1)