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

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ClinicalTrials.gov Identifier: NCT01806116
Recruitment Status : Unknown
Verified March 2013 by The First Affiliated Hospital of Soochow University.
Recruitment status was:  Active, not recruiting
First Posted : March 7, 2013
Last Update Posted : March 12, 2013
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University

Brief Summary:
Allogeneic stem cell transplantation (SCT) is the only potentially curative therapy for patients with myelodysplastic syndrome (MDS) and acute myeloblastic leukemia (AML). Relapse remains a leading cause for treatment failure after hematopoietic cell transplantation (HCT) in patients,so that there is the need to continue to look for alternative therapies. Decitabine, is known to inhibit DNA methyltransferase which results in DNA hypomethylation and expression of silenced genes including those involved in apoptosis. The approval of decitabine for the treatment of MDS and AML has provided an alternative strategy to inhibit disease progression in transplant-eligible patients. To assess the effect of pretransplant decitabine treatment on post transplant outcomes, we recently reviewed our institutional experience with MDS and AML patients.

Condition or disease Intervention/treatment Phase
Higher-risk Myelodysplastic Syndrome Relapsed /Refractory Acute Myeloid Leukemia Drug: decitabine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation
Study Start Date : September 2009
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : May 2014


Arm Intervention/treatment
Experimental: decitabine + transplantation Drug: decitabine



Primary Outcome Measures :
  1. overall survival rates [ Time Frame: three years ]

Secondary Outcome Measures :
  1. disease free survival [ Time Frame: three years ]

Other Outcome Measures:
  1. The incidences of acute and chronic graft-versus-host disease [ Time Frame: three years ]


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Ages Eligible for Study:   8 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806116


Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
Investigators
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Principal Investigator: Wu depei, Phd First Affiliated Hospital, Soochow University

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Responsible Party: The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT01806116     History of Changes
Other Study ID Numbers: hematology-01
First Posted: March 7, 2013    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013

Keywords provided by The First Affiliated Hospital of Soochow University:
myelodysplastic syndrome
higher-risk
acute myeloid leukemia
relapsed /refractory
decitabine
hematopoietic cell transplantation
bridge therapy

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