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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


Phase 3
55 Years
N/A
Open (Enrolling)
Both
Leukemia, Myeloid, Acute

Thank you

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