Azacitidine in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT01083706|
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : May 24, 2017
Last Update Posted : May 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: azacitidine Other: laboratory biomarker analysis||Phase 2|
I. To improve overall survival in patients with post-transplant relapse of myeloid malignancies.
Patients receive azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Post-Transplant Relapse and Persistent Disease in Patients With MDS, CMML and AML With Azacitidine|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||December 2013|
Experimental: 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.
Given SC or IV
Other: laboratory biomarker analysis
- Overall Survival [ Time Frame: 6 months ]Count of surviving participants at 6 months.
- Rate of Response by IWG Criteria [ Time Frame: 6 months ]Count of participants achieving a complete or partial remission at 6 months.
- Incidence of Grades II-IV Graft-versus-host Disease (GVHD) [ Time Frame: 6 months ]
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): NCT01083706
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Bart Scott||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|