We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Azacitidine in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01083706
First Posted: March 10, 2010
Last Update Posted: May 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Celgene Corporation
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bart Scott, Fred Hutchinson Cancer Research Center
Results First Submitted: April 17, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Childhood Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Myeloid Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Interventions: Drug: azacitidine
Other: laboratory biomarker analysis

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Chemotherapy)

Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

azacitidine: Given SC or IV

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Chemotherapy)
STARTED   39 
COMPLETED   39 
NOT COMPLETED   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment (Chemotherapy)

Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

azacitidine: Given SC or IV

laboratory biomarker analysis: Correlative studies


Baseline Measures
   Treatment (Chemotherapy) 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Years]
Median (Full Range)
 52 
 (23 to 76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      18  46.2% 
Male      21  53.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: 6 months ]

2.  Secondary:   Rate of Response by IWG Criteria   [ Time Frame: 6 months ]

3.  Secondary:   Incidence of Grades II-IV Graft-versus-host Disease (GVHD)   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Bart Scott
Organization: Fred Hutchinson Cancer Research Center
phone: 206-667-1990
e-mail: bscott@fredhutch.org



Responsible Party: Bart Scott, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01083706     History of Changes
Other Study ID Numbers: 2240.00
NCI-2010-00281 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2240.00 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
P01CA078902 ( U.S. NIH Grant/Contract )
First Submitted: March 8, 2010
First Posted: March 10, 2010
Results First Submitted: April 17, 2017
Results First Posted: May 24, 2017
Last Update Posted: May 24, 2017