A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best-supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission
55 Years
N/A
Both
Leukemia, Myeloid, Acute
Trial Information
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best-supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission
This is an international, multicenter, placebo-controlled, phase 3 study with a
double-blind, randomized, parallel-group design with de novo AML (Acute Myeloid Leukemia) or
AML secondary to prior diagnosis of Myelodysplastic Syndromes (MDS).
Inclusion Criteria:
1. Male or female subjects ≥ 55 years of age
2. Newly diagnosed, confirmed de novo AML or AML Secondary to prior MDS
3. First CR/CRi with induction therapy ± consolidation therapy within 90 days of
achieving CR
4. Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, 2, 3
Exclusion Criteria:
1. AML with inv(16), t(8;21), t(16;16), t(15;17), or t(9;22) or molecular evidence of
such translocations
2. Prior bone marrow or stem cell transplantation
3. Candidate for allogeneic bone marrow or stem cell transplant
4. Have achieved CR/CRi following therapy with hypomethylating agents
5. Diagnosis of malignant disease within the previous 12 months
6. Proven Central Nervous System (CNS) leukemia
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Overall Survival (OS)
Outcome Description:
Number of participants who survive
Outcome Time Frame:
60 months
Safety Issue:
Yes
Principal Investigator
Barry Skikne, MD
Investigator Role:
Study Director
Investigator Affiliation:
Celgene Corporation
Authority:
United States: Food and Drug Administration
Study ID:
CC-486-AML-001
NCT ID:
NCT01757535
Start Date:
December 2012
Completion Date:
February 2018
Related Keywords:
- Leukemia, Myeloid, Acute
- Maintenance therapy
- AML
- Acute Myeloid Leukemia
- oral Azacitidine
- best supportive care
- complete remission
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| New York Medical College | Valhalla, New York 10595 |
| Winthrop University Hospital | Mineola, New York 11501 |
| Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
| Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
| Duke University Medical Center | Durham, North Carolina 27710 |
| Arizona Oncology Associates | Tucson, Arizona 85712-2254 |
| University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |
| Providence St. Joseph Medical Center | Burbank, California 91505 |
| Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
| Kansas City VA Medical Center | Kansas City, Missouri 64128 |
| Cancer Care Center of South Texas | San Antonio, Texas 78229 |
| Cancer Center of Central Connecticut | Southington, Connecticut |
| Yakima Valley Memorial Hospital / North Star Lodge | Yakima, Washington 98902 |
| Innovative Clinical Research Institute, LLC | Whittier, California 90603 |
| Vanderbilt University Medical Center | Atlanta, Georgia 31192 |
| New York Presbyterian Hospital - Weill-Cornell | New York, New York 10021 |
| Seidman Clinical Trials | Cleveland, Ohio 44106 |
