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