Clinical Trials /

Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission

NCT01757535

Description:

This study will enroll approximately 460 subjects, aged 55 or older, with a diagnosis of de novo AML (Acute Myeloid Leukemia) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML), and who have achieved first Complete remission (CR)/ Complete remission with incomplete blood count recovery (CRi) following induction with or without consolidation chemotherapy. The study is amended to include an Extension Phase (EP). The EP allows subjects who are currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed by the Investigator, to continue receive oral azacitidine after unblinding by Sponsor (Celgene Corporation) until the subject meets the criteria for study discontinuation or until oral azacytidine becomes commercially available and reimbursed. In addition, all subjects in the placebo arm and subjects who had been discontinued from the treatment phase (irrespective of randomization arm) and continuing in the Follow-up Phase will be followed for survival in the EP.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CC-486-AML-001
  • SECONDARY ID: 2012-003457-28
  • NCT ID: NCT01757535

Conditions

  • Leukemia, Myeloid, Acute

Interventions

DrugSynonymsArms
300 mg Oral AzacitidineOral Azacitidine
PlaceboPlacebo

Purpose

This study will enroll approximately 460 subjects, aged 55 or older, with a diagnosis of de novo AML (Acute Myeloid Leukemia) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML), and who have achieved first Complete remission (CR)/ Complete remission with incomplete blood count recovery (CRi) following induction with or without consolidation chemotherapy. Subjects who have previously achieved CR/CRi with a hypomethylating agent will be excluded from the study.

Detailed Description

      This is an international, multicenter, placebo-controlled, phase3 study with a double-blind,
      randomized, parallel-group design with de novo AML (Acute Myeloid Leukemia) or AML secondary
      to prior diagnosis of Myelodysplasic Syndromes (MDS) or chronic myelomonocytic leukemia
      (CMML)
    

Trial Arms

NameTypeDescriptionInterventions
Oral AzacitidineExperimental300mg Oral Azacitidine for the first 14 days of each 28 days treatment cycle
  • 300 mg Oral Azacitidine
PlaceboPlacebo Comparator300 mg Placebo for the first 14 days of each 28 days treatment cycle
  • Placebo

Eligibility Criteria

        Inclusion Criteria:

          1. Male or female subjects ≥ 55 years of age

          2. Newly diagnosed, histologically confirmed de novo AML or AML secondary to prior
             myelodysplastic disease or CMML (Chronic myelomonocytic leukemia)

          3. First Complete remission (CR)/ Complete remission with incomplete blood count recovery
             (CRi) with induction therapy + consolidation therapy within 4 months (+/- 7 days of
             achieving CR or CRi)

          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. Have achieved CR/CRi following therapy with hypomethylating agents

          4. Diagnosis of malignant disease within the previous 12 months

          5. Proven Central Nervous System (CNS) leukemia
      
Maximum Eligible Age:N/A
Minimum Eligible Age:55 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:60 months
Safety Issue:
Description:Number of participants who survive

Secondary Outcome Measures

Measure:Relapse free survival (RFS)
Time Frame:60 months
Safety Issue:
Description:Number of participants who survive without relapsing
Measure:Complete Remission (CR)/Complete Remission with incomplete blood count recovery (CRi)
Time Frame:60 months
Safety Issue:
Description:Time to relapse from Complete Remission (CR)/Complete Remission with incomplete blood count recovery (CRi). Time to relapse from CR/CRi is defined as the interval from the date of randomization to the date of documented relapse after CR or CRi, as defined according to the IWG AML response criteria.
Measure:Safety and Tolerability
Time Frame:60 months
Safety Issue:
Description:Number of participants with adverse events
Measure:Healthcare Resource Utilization
Time Frame:60 months
Safety Issue:
Description:Effect of oral azacitidine compared with Placebo on healthcare utilization. Healthcare utilization data will be collected as described below: Information on each hospitalization will be collected utilizing a CRF designed specifically for this purpose. Information to be collected will include, but not be limited to, the reason for hospitalization (eg, disease relapse, AML-related illness, treatment-related AE), and days of hospitalization by treatment setting (inpatient, special care unit). Other disease- and treatment-related forms of healthcare utilization will be collected through routine study activities. These include diagnostic procedures and treatment interventions not requiring hospitalization such as those required for AML-related illness, or for treatment-related adverse events. Additionally, information on all concomitant medications and resource use associated with treatment administration for AML will be collected. Healthcare resource utilization information will be
Measure:Patient-reported outcomes utilizing the FACIT-Fatigue Scale and the EQ-5D
Time Frame:60 months
Safety Issue:
Description:FACT-F Functional Assessment of Cancer Therapy-Fatigue, EuroQol-5D (EQ-5D) measure of health outcome and 3 additional exploratory questions

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Celgene

Trial Keywords

  • Maintenance therapy
  • AML
  • Acute Myeloid Leukemia
  • oral Azacitidine
  • best supportive care
  • complete remission

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