ClinicalTrials.gov
History of Changes for Study: NCT01757535
Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission (QUAZAR AML-001)
Latest version (submitted January 17, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 21, 2012 None (earliest Version on record)
2 June 6, 2013 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures and Oversight
3 August 28, 2013 Contacts/Locations and Study Status
4 September 27, 2013 Study Status and Contacts/Locations
5 November 5, 2013 Study Status and Contacts/Locations
6 November 27, 2013 Contacts/Locations and Study Status
7 January 8, 2014 Study Status and Contacts/Locations
8 February 4, 2014 Study Status and Contacts/Locations
9 March 4, 2014 Study Status and Contacts/Locations
10 April 7, 2014 Study Status and Contacts/Locations
11 July 7, 2014 Study Status and Contacts/Locations
12 August 19, 2014 Contacts/Locations and Study Status
13 December 12, 2014 Study Status and Contacts/Locations
14 February 27, 2015 Contacts/Locations and Study Status
15 June 11, 2015 Study Status
16 August 26, 2015 Contacts/Locations and Study Status
17 October 6, 2015 Contacts/Locations and Study Status
18 October 30, 2015 Contacts/Locations and Study Status
19 December 8, 2015 Contacts/Locations and Study Status
20 December 23, 2015 Contacts/Locations and Study Status
21 January 20, 2016 Contacts/Locations and Study Status
22 February 12, 2016 Study Description, Study Status, Contacts/Locations and Eligibility
23 March 10, 2016 Study Status
24 April 7, 2016 Contacts/Locations, Study Status and Study Identification
25 May 3, 2016 Contacts/Locations and Study Status
26 June 3, 2016 Contacts/Locations and Study Status
27 June 29, 2016 Study Status and Contacts/Locations
28 August 8, 2016 Study Status and Contacts/Locations
29 August 11, 2016 Contacts/Locations and Study Status
30 November 3, 2016 Contacts/Locations and Study Status
31 November 28, 2016 Contacts/Locations and Study Status
32 December 28, 2016 Study Status and Contacts/Locations
33 January 24, 2017 Contacts/Locations, Outcome Measures, Sponsor/Collaborators, Study Status, Study Identification and Eligibility
34 January 30, 2017 Contacts/Locations and Study Status
35 May 9, 2017 Study Status and Contacts/Locations
36 June 28, 2017 Study Status and Contacts/Locations
37 July 25, 2017 Contacts/Locations and Study Status
38 August 31, 2017 Study Status and Contacts/Locations
39 September 27, 2017 Study Status and Contacts/Locations
40 October 2, 2017 Study Status and Contacts/Locations
41 October 31, 2017 Recruitment Status, Contacts/Locations, Study Status and Study Design
42 November 2, 2017 Study Status
43 December 21, 2017 Study Status and Study Design
44 February 28, 2018 Study Status, Contacts/Locations and Study Design
45 April 9, 2018 Study Status
46 April 24, 2018 Study Status
47 May 14, 2018 Study Status
48 September 12, 2018 Study Status
49 October 16, 2018 Study Status
50 October 29, 2018 Study Status
51 April 10, 2019 Study Status, Study Description, Contacts/Locations and Eligibility
52 July 17, 2019 Study Status
53 August 19, 2019 Study Status and References
54 October 16, 2019 Study Status
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Results Submission Events
55 November 4, 2020 Outcome Measures, Study Status, More Information, Document Section, Adverse Events, Baseline Characteristics and Participant Flow
56 April 28, 2021 Arms and Interventions, Study Description, Study Status, Study Identification, Contacts/Locations, Eligibility and Conditions
57 December 7, 2021 Study Status and Contacts/Locations
58 May 20, 2022 Study Status and Contacts/Locations
59 June 10, 2022 Study Status and Contacts/Locations
60 June 15, 2022 Study Status
61 July 5, 2022 Study Status and Contacts/Locations
62 July 18, 2022 Contacts/Locations and Study Status
63 August 19, 2022 Study Status
64 September 1, 2022 Study Status, References and Contacts/Locations
65 October 3, 2022 Study Status and Contacts/Locations
66 October 11, 2022 Contacts/Locations and Study Status
67 October 20, 2022 Study Status
68 November 7, 2022 Study Status
69 November 16, 2022 Contacts/Locations and Study Status
70 December 12, 2022 Study Status and Contacts/Locations
71 January 11, 2023 Study Status and Contacts/Locations
72 January 13, 2023 Contacts/Locations and Study Status
73 February 8, 2023 Study Status and Contacts/Locations
74 February 13, 2023 Contacts/Locations and Study Status
75 February 15, 2023 Contacts/Locations and Study Status
76 February 28, 2023 Contacts/Locations and Study Status
77 March 7, 2023 Study Status
78 April 27, 2023 Study Status
79 June 21, 2023 Study Status
80 July 24, 2023 Study Status
81 January 17, 2024 Study Status, References and Contacts/Locations
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Study NCT01757535
Submitted Date:  December 21, 2012 (v1)
Open or close this module Study Identification
Unique Protocol ID: CC-486-AML-001
Brief Title: Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission (QUAZAR AML-001)
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
Secondary IDs: 2012-003457-28 [EudraCT Number]
Open or close this module Study Status
Record Verification: December 2012
Overall Status: Not yet recruiting
Study Start: December 2012
Primary Completion: November 2017 [Anticipated]
Study Completion: February 2018 [Anticipated]
First Submitted: November 21, 2012
First Submitted that
Met QC Criteria:		 December 21, 2012
First Posted: December 31, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:		 December 21, 2012
Last Update Posted: December 31, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Celgene Corporation
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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 (AML), age = or >55 years, who have achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after induction with intensive chemotherapy with or without consolidation chemotherapy.
Detailed Description: 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).
Open or close this module Conditions
Conditions: Leukemia, Myeloid, Acute
Keywords: Maintenance therapy
AML
Acute Myeloid Leukemia
oral Azacitidine
best supportive care
complete remission
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 460 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Oral Azacitidine
300mg Oral Azacitidine for the first 14 days of each 28 days treatment cycle
 Drug: 300 mg Oral Azacitidine
Maintenance therapy
Placebo Comparator: Placebo
300 mg Placebo for the first 14 days of each 28 days treatment cycle
 Drug: Placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall Survival (OS)
[ Time Frame: 60 months ]

Number of participants who survive
Secondary Outcome Measures:
1. Relapse free survival (RFS)
[ Time Frame: 60 months ]

Number of participants who survive without relapsing
2. Complete Remission (CR)/Complete Remission with incomplete blood count recovery (CRi)
[ Time Frame: 60 months ]

Time to relapse from Complete Remission (CR)/Complete Remission with incomplete blood count recovery (CRi)
3. Safety and Tolerability
[ Time Frame: 60 months ]

Number of participants with adverse events
4. Healthcare Resource Utilization
[ Time Frame: 60 months ]

Information on each hospitalization will be collected utilizing a specific CRF. Information to be collected may include, the reason for hospitalization (eg, AML 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 for AML will be collected. Healthcare resource utilization information will be collected after a subject signs informed consent through 28 days after the last dose of Investigational Product (IP) or until the date of last study visit, whichever is later
5. Health-related quality-of-life (HRQoL)
[ Time Frame: 60 months ]

FACT-F Functional Assessment of Cancer Therapy-Fatigue, EuroQol-5D (EQ-5D) measure of health outcome and 3 additional exploratory questions
Open or close this module Eligibility
Minimum Age: 55 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Arti KONOPKA, Lead Study Manager
Telephone: +41 32 729 87 10
Email: akonopka@celgene.com
Study Officials: Barry Skikne, MD
Study Director
Celgene Corporation
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services