Know Cancer

or
forgot password

Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation


Phase 4
8 Years
65 Years
Open (Enrolling)
Both
Higher-risk Myelodysplastic Syndrome, Relapsed /Refractory Acute Myeloid Leukemia

Thank you

Trial Information

Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation


Inclusion Criteria:



- Age 8- 65 years

- Diseases must be myelodysplastic syndrome and acute myelocytic leukemia

- Must need a bone marrow transplant

- Must have the ability to observe the efficacy and events

- Patient must have ability to understand and willingness to provide written informed
consent prior to participation in the study and any related procedures being
performed

Exclusion Criteria:

- Must not have uncontrolled intercurrent illness including ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, or
psychiatric illness/social situations that would limit compliance with study
requirements

- Must not be pregnant or breastfeeding; pregnant women are excluded from this study
because decitabine is a Category D agent with the potential for teratogenic or
abortifacient effects; because there is an unknown but potential risk for adverse
events in nursing infants secondary to treatment of the mother with decitabine,
breastfeeding should be discontinued if the mother is treated with decitabine; these
potential risks may also apply to other agents used in this study

- Must not have a known or suspected hypersensitivity to decitabine

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival rates

Outcome Time Frame:

three years

Safety Issue:

Yes

Principal Investigator

Wu depei, Phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

First Affiliated Hospital, Soochow University

Authority:

China: Ethics Committee

Study ID:

hematology-01

NCT ID:

NCT01806116

Start Date:

September 2009

Completion Date:

May 2014

Related Keywords:

  • Higher-risk Myelodysplastic Syndrome
  • Relapsed /Refractory Acute Myeloid Leukemia
  • myelodysplastic syndrome
  • higher-risk
  • acute myeloid leukemia
  • relapsed /refractory
  • decitabine
  • hematopoietic cell transplantation
  • bridge therapy
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location