Back to results

Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission (QUAZAR AML-001)

Primary Purpose

Leukemia, Myeloid, Acute

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Oral Azacitidine

Placebo

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring Maintenance therapy, AML, Acute Myeloid Leukemia, Oral Azacitidine, Best supportive care, Complete remission

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Male or female participants ≥ 55 years of age
Newly diagnosed, histologically confirmed de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or CMML (Chronic myelomonocytic leukemia)
First complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) with induction therapy with intensive chemotherapy with or without consolidation therapy within 4 months (+/- 7 days of achieving CR or CRi)
Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, 2, 3

Key Inclusion Criteria in the Extended Phase of the study:

At the Investigator's discretion and with approval of the sponsor, participants meeting all of the following eligibility criteria are eligible to enter the extension phase:

All participants randomized into the oral azacitidine or placebo arm and are continuing in either the treatment phase or follow-up phase of the CC-486-AML-001 study;
- Participants randomized to oral azacitidine treatment arm and continuing in the treatment phase demonstrating clinical benefit as assessed by the investigator are eligible to receive oral azacitidine in the extension phase (EP);
- Participants randomized into placebo arm of the study will not receive oral azacitidine in the EP, but will be followed for survival in the EP;
- Participants currently in the follow-up phase will continue to be followed for survival in the EP;
Participants who have signed the informed consent for the EP of the study;
Participants who do not meet any of the criteria for study discontinuation

Key Exclusion Criteria:

AML with inversion (inv)(16), translocation = t(8;21), t(16;16), t(15;17), or t(9;22) or molecular evidence of such translocations
Prior bone marrow or stem cell transplantation
Have achieved CR/CRi following therapy with hypomethylating agents
Diagnosis of malignant disease within the previous 12 months
Proven central nervous system (CNS) leukemia

Sites / Locations

Arizona Oncology Associates, P.C.
Providence St Joseph Medical Center Cancer Center
City Of Hope
University of California San Francisco Fresno Campus
University of Southern California Norris Cancer Center
Ucla
Local Institution - 050
Sharp Memorial Hospital
Stanford Cancer Center
Innovative Clinical Research Institute
Rocky Mountain Cancer Center
The Hospital of Central Connecticut
George Washington University Cancer Center
University Of Florida
Mount Sinai Comprehensive Cancer Center
University of Florida Health Cancer Center at Orlando Health
Northwestern University Medical Center
Loyola University Chicago
Cancer Care and Hematology Specialists of Chicagoland, P.C. - Niles, IL
Indiana University Cancer Center
Franciscan St. Francis Health
Kansas University Medical Center
University Of Louisville
Norton Cancer Institute Louisville Oncology
Tulane University Medical Center
Ochsner Medical Center - Jefferson Highway
Beth Israel Deaconess Medical Center
University of Massachusetts
Local Institution - 037
Kansas City VA Medical Center University of Kansas Medical Center
Washington University School Of Medicine
University Of Nebraska Medical Center
John Theurer Cancer Center at Hackensack University Medical Center
Cancer Institute of New Jersey
Winthrop University Hospital
Mt. Sinai Medical Center
Columbia University Irving Medical Center
Local Institution - 002
University of Rochester Medical Center
Local Institution - 014
Duke University Medical Center
Local Institution - 025
Local Institution - 016
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Kaiser Permanente Northwest Oncology Hematology
Lancaster General Hospital
UPMC Cancer Pavillion
Greenville Hospital System
Sarah Cannon Research Inst
Vanderbilt University Medical Center
University Of Texas Southwestern Medical Center
Brooke-Army Medical Center
MD Anderson Cancer Center
Cancer Care Centers of South Texas - Loop
Methodist Hospital
VA Commonwealth University - Massey Cancer Center
Swedish Cancer Inst
Yakima Valley Memorial Hospital/ North Star Lodge
Froedtert Hospital BMT Medical College of Wisconsin
Local Institution - 510
Local Institution - 509
Local Institution - 508
Local Institution - 511
Local Institution - 504
Local Institution - 503
Local Institution - 502
Local Institution - 507
Local Institution - 500
Local Institution - 505
Local Institution - 512
Local Institution - 506
Local Institution - 501
Local Institution - 271
Local Institution - 270
Local Institution - 274
Local Institution - 273
Local Institution - 272
Local Institution - 300
Local Institution - 301
Local Institution - 302
Local Institution - 233
Local Institution - 231
Local Institution - 232
Local Institution - 230
Local Institution - 234
Local Institution - 605
Local Institution - 600
Local Institution - 601
Local Institution - 603
Local Institution - 604
Local Institution - 607
Local Institution - 608
Local Institution - 602
Local Institution - 320
Local Institution - 321
Local Institution - 322
Local Institution - 361
Local Institution - 362
Local Institution - 360
Local Institution - 456
Local Institution - 465
Local Institution - 457
Local Institution - 462
Local Institution - 460
Local Institution - 452
Local Institution - 458
Local Institution - 453
Local Institution - 461
Local Institution - 450
Local Institution - 800
Local Institution - 463
Local Institution - 454
Local Institution - 464
Local Institution - 455
Local Institution - 459
Local Institution - 451
Local Institution - 400
Local Institution - 413
Local Institution - 410
Local Institution - 406
Local Institution - 415
Local Institution - 404
Local Institution - 412
Local Institution - 405
Local Institution - 408
Local Institution - 414
Local Institution - 403
Local Institution - 402
Local Institution - 409
Local Institution - 411
Local Institution - 407
Local Institution - 416
Local Institution - 401
Local Institution - 950
Local Institution - 951
Local Institution - 381
Local Institution - 380
Local Institution - 383
Local Institution - 382
Local Institution - 701
Local Institution - 721
Local Institution - 720
Local Institution - 710
Local Institution - 702
Local Institution - 708
Local Institution - 712
Local Institution - 716
Local Institution - 726
Local Institution - 706
Local Institution - 704
Local Institution - 717
Local Institution - 725
Local Institution - 705
Local Institution - 703
Local Institution - 719
Local Institution - 724
Local Institution - 700
Local Institution - 709
Local Institution - 714
Local Institution - 723
Local Institution - 722
Local Institution - 715
Local Institution - 718
Local Institution - 711
Local Institution - 707
Local Institution - 535
Local Institution - 533
Local Institution - 536
Local Institution - 530
Local Institution - 531
Local Institution - 532
Local Institution - 750
Local Institution - 252
Local Institution - 251
Local Institution - 250
Local Institution - 824
Local Institution - 820
Local Institution - 822
Local Institution - 821
Local Institution - 823
Local Institution - 841
Local Institution - 840
Local Institution - 843
Local Institution - 842
Local Institution - 844
Local Institution - 971
Local Institution - 970
Local Institution - 972
Local Institution - 973
Local Institution - 872
Local Institution - 869
Local Institution - 871
Local Institution - 870
Local Institution - 873
Local Institution - 863
Local Institution - 867
Local Institution - 868
Local Institution - 866
Local Institution - 865
Local Institution - 864
Local Institution - 861
Local Institution - 862
Local Institution - 860
Local Institution - 599
Local Institution - 595
Local Institution - 596
Local Institution - 597
Local Institution - 598
Local Institution - 653
Local Institution - 650
Local Institution - 651
Local Institution - 652
Local Institution - 904
Local Institution - 907
Local Institution - 903
Local Institution - 902
Local Institution - 905
Local Institution - 901
Local Institution - 908
Local Institution - 909
Local Institution - 900
Local Institution - 906

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oral Azacitidine

Placebo

Arm Description

300 mg oral azacitidine on days 1 to 14 of each 28-day treatment cycle.

Identically matching placebo tablets on days 1 to 14 of each 28-day treatment cycle.

Outcomes

Primary Outcome Measures

Kaplan-Meier (K-M) Estimate for Overall Survival (OS)

Overall survival was defined as time from randomization to death from any cause; participants surviving at the end of the follow-up period, or who withdraw consent, or who were lost to follow up were censored at the date last known alive.

Secondary Outcome Measures

Kaplan-Meier Estimate of Relapse Free Survival (RFS)

RFS was defined as the time from the date of randomization to the date of documented relapse or death from any cause, whichever occurred first. Participants who were still alive without documented relapse, or who were lost to follow-up or withdrew consent without documented relapse, were censored at the date of their last bone marrow assessment, prior to receiving any other therapy for AML. Documented relapse was defined as the earliest date of the following: ≥ 5% bone marrow blasts (myeloblasts) from Central Pathology report, or appearance of > 0% blasts in the peripheral blood with a later bone marrow confirmation (bone marrow blast [myeloblasts] ≥ 5%) within 100 days, or at least 2 peripheral blasts ≥ 5% within 30 days.

Kaplan-Meier Estimate of Time to Relapse

Time to relapse was defined as the interval (in months) from the date of randomization to the date of documented relapse. Estimates of relapse rate were based on the cumulative incidence function from a competing risk analysis with death as a competing risk for relapse from complete remission (CR)/ complete remission with incomplete blood count recovery (CRi). Documented relapse was defined as, the earliest date of the following: ≥ 5% bone marrow blasts (myeloblasts) from Central Pathology report, or appearance of > 0% blasts in the peripheral blood with a later bone marrow confirmation (bone marrow blast [myeloblasts] ≥ 5%) within 100 days, or at least 2 peripheral blasts ≥ 5% within 30 days.

Kaplan-Meier Estimates of Time to Discontinuation From Treatment

Time to discontinuation from treatment was assessed and defined as the interval from the date of randomization to the date of discontinuation from study drug. Participants who were receiving treatment at the time of study closure were censored at the date of last visit. Estimates of relapse rate were based on the cumulative incidence function from a competing risk analysis with death as a competing risk for relapse from CR/ CRi.

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

TEAEs include AEs that started between first dose date and 28 days after the last dose of study drug. A serious adverse event (SAE) is: Death Life-threatening event Inpatient hospitalization or prolongation of existing hospitalization Persistent or significant disability or incapacity Congenital anomaly or birth defect Other important medical event The severity of AEs were assessed by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0: Grade 1 (Mild): asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 (Moderate): minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care Grade 4: Life-threatening; urgent intervention indicated. Grade 5: Death due to AE.

Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue Scale V 4.0) Score From Baseline

The functional assessment of chronic illness therapy (FACIT-Fatigue Scale V 4.0) is a subscale of the FACIT-F and has been validated in the oncology setting. The FACIT-Fatigue Scale is a short, 13-item, self-administered tool that measures the level of fatigue in an individual during usually daily activities over the past week. The level of fatigue is measured on a 5-point Likert scale (0 = not at all; 4 = very much. The scores range from 0 to 52, with higher scores indicating less fatigue. If there were missing items, but the participant answered at least 50% of the items, then subscores were prorated.

Mean Change in the European Quality of Life-Five Dimensions-Three Levels (EQ-5D-3L) Score From Baseline

The EQ-5D-3L is a self-administered questionnaire consisting of 5 questions, pertaining to specific health dimensions (ie, mobility, self-care, pain, usual activities, and anxiety/depression) and a health status scale. Each question has 3 levels of severity, corresponding to no problems, moderate problems and severe problems. Canadian population sample weights were used to derive health utility scores. A higher utility score represents a better health state. A clinically meaningful improvement or worsening was defined as at least 0.08 points of improvement or 0.10 points of worsening from baseline, respectively, for the EQ-5D-3L Health Utility Index. The instrument is scored using the United Kingdom (UK) index ranges from -0.594 to 1, where 0 equates to death and 1 equates to full health; -0.594 is considered 'worse than death'.

Percentage of Participants Experiencing a Clinically Meaningful Change (Improvement, No Change and Deterioration) in the FACIT-Fatigue Scale From Baseline

A clinically meaningful improvement or worsening was defined as at least 3 points of improvement or worsening from baseline, respectively, for FACIT-Fatigue. The functional assessment of chronic illness therapy (FACIT-Fatigue Scale V 4.0) is a subscale of the FACIT-F and has been validated in the oncology setting. The FACIT-Fatigue Scale is a short, 13-item, self-administered tool that measures the level of fatigue in an individual during usually daily activities over the past week. The level of fatigue is measured on a 5-point Likert scale (0 = not at all; 4 = very much. The scores range from 0 to 52, with higher scores indicating less fatigue. If there were missing items, but the participant answered at least 50% of the items, then subscores were prorated.

Percentage of Participants Experiencing a Clinically Meaningful Change (Improvement, No Change and Deterioration) in the EQ-5D-3L Scale From Baseline

Time to Definitive Clinically Meaningful Deterioration for ≥ 2 Consecutive Visits as Measured Using the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue Scale V 4.0)

Clinically meaningful deterioration was defined as at least 3 points of deterioration from baseline for at least 2 consecutive visits for the FACIT--Fatigue. The FACIT-Fatigue Scale V 4.0) is a subscale of the FACIT-F and has been validated in the oncology setting. The FACIT-Fatigue Scale is a short, 13-item, self-administered tool that measures the level of fatigue in an individual during usually daily activities over the past week. The level of fatigue is measured on a 5-point Likert scale (0 = not at all to 4 = very much. The scores that range from 0 to 52, with higher scores indicating less fatigue. If there were missing items, but the participant answered at least 50% of the items, subscores were prorated.

Time to Definitive Clinically Meaningful Deterioration for ≥ 2 Consecutive Visits as Measured Using the EQ-5D HRQoL Scale

Clinically meaningful deterioration was defined at least 0.10 point of deterioration from baseline for at least 2 consecutive visits for the EQ-5D Health Utility Index. The EQ-5D-3L is a self-administered questionnaire consisting of 5 questions, pertaining to specific health dimensions (ie, mobility, self-care, pain, usual activities, and anxiety/depression) and a health status scale. Each question has 3 levels of severity, corresponding to no problems, moderate problems and severe problems. Canadian population sample weights were used to derive health utility scores. A higher utility score represents a better health state. A clinically meaningful improvement or worsening was defined as at least 0.08 points of improvement or 0.10 points of worsening from baseline, respectively, for the EQ-5D-3L Health Utility Index. The EQ-5D-3L is scored using the UK index ranges from -0.594 to 1, where 0 equates to death and 1 equates to full health; -0.594 is considered 'worse than death'.

Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Person Year

HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.

Healthcare Resource Utilization (HRU): Number of Days Hospitalized Per Person-Year

Full Information

NCT ID

NCT01757535

First Posted

November 21, 2012

Last Updated

July 24, 2023

Sponsor

Celgene

1. Study Identification

Unique Protocol Identification Number

NCT01757535

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 24, 2013 (Actual)

Primary Completion Date

July 15, 2019 (Actual)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Celgene

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study enrolled 472 participants, aged 55 or older, with a diagnosis of de novo acute myeloid leukemia (AML) 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 participants who are currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed by the investigator, to continue receiving oral azacitidine after unblinding by sponsor until the participant meets the criteria for study discontinuation or until oral azacitidine becomes commercially available and reimbursed. In addition, all participants in the placebo arm and participants 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.

Detailed Description

This is an international, multicenter, placebo-controlled, Phase 3 study with a double-blind, randomized, parallel-group design in subjects with de novo AML or AML secondary to prior diagnosis of myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) aged ≥ 55 years, who are in first CR/CRi following induction therapy with or without consolidation chemotherapy. The study consists of 3 phases; the pre-randomization phase (screening phase), the treatment phase, and the follow-up phase. The study is amended to include an extension phase (EP). The EP allows participants who are currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed by the Investigator, to continue receiving oral azacitidine after unblinding by sponsor until they meet the criteria for study discontinuation or until oral azacitidine becomes commercially available and reimbursed. In addition, all participants in the placebo arm and participants 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Myeloid, Acute

Keywords

Maintenance therapy, AML, Acute Myeloid Leukemia, Oral Azacitidine, Best supportive care, Complete remission

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

472 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Azacitidine

Arm Type

Experimental

Arm Description

300 mg oral azacitidine on days 1 to 14 of each 28-day treatment cycle.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Identically matching placebo tablets on days 1 to 14 of each 28-day treatment cycle.

Intervention Type

Drug

Intervention Name(s)

Oral Azacitidine

Other Intervention Name(s)

CC-486; Onureg®

Intervention Description

300 mg oral azacitidine on days 1 to 14 of each 28-day treatment cycle.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Identically matching placebo tablets on days 1 to 14 of each 28-day treatment cycle.

Primary Outcome Measure Information:

Title

Kaplan-Meier (K-M) Estimate for Overall Survival (OS)

Description

Time Frame

Day 1 (randomization) up to data cut off date of 15 July 2019; median follow-up for OS estimated by the reverse K-M method was 41.2 months for all participants.

Secondary Outcome Measure Information:

Title

Kaplan-Meier Estimate of Relapse Free Survival (RFS)

Description

Time Frame

From day 1 (randomization) up to data cut off date of 15 July 2019; approximately 74 months

Title

Kaplan-Meier Estimate of Time to Relapse

Description

Time Frame

Day 1 (randomization) to the date of the data cut off date of 15 July 2019; approximately 74 months

Title

Kaplan-Meier Estimates of Time to Discontinuation From Treatment

Description

Time Frame

From day 1 (randomization) up to data cut off date of 15 July 2019; approximately 74 months

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Description

Time Frame

Day 1 (randomization) to the data cut off date of 15 July 2019; the median treatment duration was 11.6 months (range: 0.5 to 74.3 months) for the oral aza arm and 5.7 months (range: 0.7 to 68.5 months) for the placebo arm.

Title

Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue Scale V 4.0) Score From Baseline

Description

Time Frame

Baseline to Cycle 2, Day 1 (C2D1), C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1C3, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, C23D1, C24D1, C25D1 and continued on day 1 at each cycle through C33D1

Title

Mean Change in the European Quality of Life-Five Dimensions-Three Levels (EQ-5D-3L) Score From Baseline

Description

Time Frame

Title

Percentage of Participants Experiencing a Clinically Meaningful Change (Improvement, No Change and Deterioration) in the FACIT-Fatigue Scale From Baseline

Description

Time Frame

Title

Percentage of Participants Experiencing a Clinically Meaningful Change (Improvement, No Change and Deterioration) in the EQ-5D-3L Scale From Baseline

Description

Time Frame

Title

Time to Definitive Clinically Meaningful Deterioration for ≥ 2 Consecutive Visits as Measured Using the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue Scale V 4.0)

Description

Time Frame

From day 1 (randomization) up to data cut off date of 15 July 2019; approximately 74 months

Title

Time to Definitive Clinically Meaningful Deterioration for ≥ 2 Consecutive Visits as Measured Using the EQ-5D HRQoL Scale

Description

Time Frame

From day 1 (randomization) up to data cut off date of 15 July 2019; approximately 74 months

Title

Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Person Year

Description

Time Frame

Day 1 (randomization) to the date of the data cut off date of 15 July 2019; approximately 74 months

Title

Healthcare Resource Utilization (HRU): Number of Days Hospitalized Per Person-Year

Description

Time Frame

Day 1 (randomization) to the date of the data cut off date of 15 July 2019; approximately 74 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Male or female participants ≥ 55 years of age Newly diagnosed, histologically confirmed de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or CMML (Chronic myelomonocytic leukemia) First complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) with induction therapy with intensive chemotherapy with or without consolidation therapy within 4 months (+/- 7 days of achieving CR or CRi) Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, 2, 3 Key Inclusion Criteria in the Extended Phase of the study: At the Investigator's discretion and with approval of the sponsor, participants meeting all of the following eligibility criteria are eligible to enter the extension phase: All participants randomized into the oral azacitidine or placebo arm and are continuing in either the treatment phase or follow-up phase of the CC-486-AML-001 study; Participants randomized to oral azacitidine treatment arm and continuing in the treatment phase demonstrating clinical benefit as assessed by the investigator are eligible to receive oral azacitidine in the extension phase (EP); Participants randomized into placebo arm of the study will not receive oral azacitidine in the EP, but will be followed for survival in the EP; Participants currently in the follow-up phase will continue to be followed for survival in the EP; Participants who have signed the informed consent for the EP of the study; Participants who do not meet any of the criteria for study discontinuation Key Exclusion Criteria: AML with inversion (inv)(16), translocation = t(8;21), t(16;16), t(15;17), or t(9;22) or molecular evidence of such translocations Prior bone marrow or stem cell transplantation Have achieved CR/CRi following therapy with hypomethylating agents Diagnosis of malignant disease within the previous 12 months Proven central nervous system (CNS) leukemia

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Arizona Oncology Associates, P.C.

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Facility Name

Providence St Joseph Medical Center Cancer Center

City

Burbank

State/Province

California

ZIP/Postal Code

91505

Country

United States

Facility Name

City Of Hope

City

Duarte

State/Province

California

ZIP/Postal Code

91010-301

Country

United States

Facility Name

University of California San Francisco Fresno Campus

City

Fresno

State/Province

California

ZIP/Postal Code

93701

Country

United States

Facility Name

University of Southern California Norris Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Ucla

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-6956

Country

United States

Facility Name

Local Institution - 050

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Sharp Memorial Hospital

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Stanford Cancer Center

City

Stanford

State/Province

California

ZIP/Postal Code

94305-582

Country

United States

Facility Name

Innovative Clinical Research Institute

City

Whittier

State/Province

California

ZIP/Postal Code

90603

Country

United States

Facility Name

Rocky Mountain Cancer Center

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218-1210

Country

United States

Facility Name

The Hospital of Central Connecticut

City

Southington

State/Province

Connecticut

ZIP/Postal Code

06489

Country

United States

Facility Name

George Washington University Cancer Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

University Of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Mount Sinai Comprehensive Cancer Center

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

Facility Name

University of Florida Health Cancer Center at Orlando Health

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Northwestern University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Loyola University Chicago

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Cancer Care and Hematology Specialists of Chicagoland, P.C. - Niles, IL

City

Niles

State/Province

Illinois

ZIP/Postal Code

60714

Country

United States

Facility Name

Indiana University Cancer Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202-528

Country

United States

Facility Name

Franciscan St. Francis Health

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46237

Country

United States

Facility Name

Kansas University Medical Center

City

Westwood

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Facility Name

University Of Louisville

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Norton Cancer Institute Louisville Oncology

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Tulane University Medical Center

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

Ochsner Medical Center - Jefferson Highway

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70121-2483

Country

United States

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

University of Massachusetts

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

Local Institution - 037

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Kansas City VA Medical Center University of Kansas Medical Center

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64128

Country

United States

Facility Name

Washington University School Of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

University Of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198-7680

Country

United States

Facility Name

John Theurer Cancer Center at Hackensack University Medical Center

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Cancer Institute of New Jersey

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08901

Country

United States

Facility Name

Winthrop University Hospital

City

Mineola

State/Province

New York

ZIP/Postal Code

11501-3893

Country

United States

Facility Name

Mt. Sinai Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Columbia University Irving Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Local Institution - 002

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

University of Rochester Medical Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Local Institution - 014

City

Valhalla

State/Province

New York

ZIP/Postal Code

10595

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

Local Institution - 025

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Local Institution - 016

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

University of Oklahoma Peggy and Charles Stephenson Cancer Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Kaiser Permanente Northwest Oncology Hematology

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

Facility Name

Lancaster General Hospital

City

Lancaster

State/Province

Pennsylvania

ZIP/Postal Code

17604

Country

United States

Facility Name

UPMC Cancer Pavillion

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

Greenville Hospital System

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Facility Name

Sarah Cannon Research Inst

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-5505

Country

United States

Facility Name

University Of Texas Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9068

Country

United States

Facility Name

Brooke-Army Medical Center

City

Fort Sam Houston

State/Province

Texas

ZIP/Postal Code

78234

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Cancer Care Centers of South Texas - Loop

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

Methodist Hospital

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

VA Commonwealth University - Massey Cancer Center

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298-0037

Country

United States

Facility Name

Swedish Cancer Inst

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Yakima Valley Memorial Hospital/ North Star Lodge

City

Yakima

State/Province

Washington

ZIP/Postal Code

98902

Country

United States

Facility Name

Froedtert Hospital BMT Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226-3522

Country

United States

Facility Name

Local Institution - 510

City

Wollongong

State/Province

New South Wales

ZIP/Postal Code

2500

Country

Australia

Facility Name

Local Institution - 509

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Local Institution - 508

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

SA 5000

Country

Australia

Facility Name

Local Institution - 511

City

Bedford Park

State/Province

South Australia

ZIP/Postal Code

5042

Country

Australia

Facility Name

Local Institution - 504

City

Woodville South

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

Local Institution - 503

City

Heidelberg

ZIP/Postal Code

3084

Country

Australia

Facility Name

Local Institution - 502

City

Hobart

ZIP/Postal Code

7000

Country

Australia

Facility Name

Local Institution - 507

City

Liverpool

ZIP/Postal Code

2170

Country

Australia

Facility Name

Local Institution - 500

City

Melbourne

ZIP/Postal Code

3004

Country

Australia

Facility Name

Local Institution - 505

City

Perth

ZIP/Postal Code

6000

Country

Australia

Facility Name

Local Institution - 512

City

Perth

ZIP/Postal Code

6000

Country

Australia

Facility Name

Local Institution - 506

City

St Leonards

ZIP/Postal Code

2065

Country

Australia

Facility Name

Local Institution - 501

City

Woolloongabba

ZIP/Postal Code

4102

Country

Australia

Facility Name

Local Institution - 271

City

Graz

ZIP/Postal Code

73013

Country

Austria

Facility Name

Local Institution - 270

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Local Institution - 274

City

Vienna

ZIP/Postal Code

1130

Country

Austria

Facility Name

Local Institution - 273

City

Vienna

ZIP/Postal Code

1190

Country

Austria

Facility Name

Local Institution - 272

City

Wien

ZIP/Postal Code

1140

Country

Austria

Facility Name

Local Institution - 300

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Local Institution - 301

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

Local Institution - 302

City

Mons

ZIP/Postal Code

7000

Country

Belgium

Facility Name

Local Institution - 233

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

81520-060

Country

Brazil

Facility Name

Local Institution - 231

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Local Institution - 232

City

Rio de Janeiro

ZIP/Postal Code

20230-130

Country

Brazil

Facility Name

Local Institution - 230

City

Sao Paulo

ZIP/Postal Code

05651-901

Country

Brazil

Facility Name

Local Institution - 234

City

São Paulo

ZIP/Postal Code

01308-050

Country

Brazil

Facility Name

Local Institution - 605

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Local Institution - 600

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E OV9

Country

Canada

Facility Name

Local Institution - 601

City

Saint John

State/Province

New Brunswick

ZIP/Postal Code

E2L 4L2

Country

Canada

Facility Name

Local Institution - 603

City

St John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B3V6

Country

Canada

Facility Name

Local Institution - 604

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Local Institution - 607

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Local Institution - 608

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1S6

Country

Canada

Facility Name

Local Institution - 602

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4J 1C5

Country

Canada

Facility Name

Local Institution - 320

City

Brno

State/Province

Jihomoravský Kraj

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Local Institution - 321

City

Praha

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Local Institution - 322

City

Praha

ZIP/Postal Code

128 20

Country

Czechia

Facility Name

Local Institution - 361

City

Helsinki

ZIP/Postal Code

290

Country

Finland

Facility Name

Local Institution - 362

City

Tampere

ZIP/Postal Code

33521

Country

Finland

Facility Name

Local Institution - 360

City

Turku

ZIP/Postal Code

20521

Country

Finland

Facility Name

Local Institution - 456

City

Amiens

ZIP/Postal Code

80054

Country

France

Facility Name

Local Institution - 465

City

Argenteuil

ZIP/Postal Code

95100

Country

France

Facility Name

Local Institution - 457

City

Bobigny Cedex

ZIP/Postal Code

93009

Country

France

Facility Name

Local Institution - 462

City

Boulognes Sur Mer

ZIP/Postal Code

62200

Country

France

Facility Name

Local Institution - 460

City

Clamart Cedex

ZIP/Postal Code

92141

Country

France

Facility Name

Local Institution - 452

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

Local Institution - 458

City

Le Chesnay Cedex

ZIP/Postal Code

78157

Country

France

Facility Name

Local Institution - 453

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Local Institution - 461

City

Limoges Cedex

ZIP/Postal Code

87042

Country

France

Facility Name

Local Institution - 450

City

Lyon cedex

ZIP/Postal Code

69437

Country

France

Facility Name

Local Institution - 800

City

Paris Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

Local Institution - 463

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Local Institution - 454

City

Paris

ZIP/Postal Code

75475

Country

France

Facility Name

Local Institution - 464

City

Pontoise

ZIP/Postal Code

95301

Country

France

Facility Name

Local Institution - 455

City

Rouen

ZIP/Postal Code

76038

Country

France

Facility Name

Local Institution - 459

City

Saint-Cloud

ZIP/Postal Code

92210

Country

France

Facility Name

Local Institution - 451

City

Villejuif CEDEX

ZIP/Postal Code

94805

Country

France

Facility Name

Local Institution - 400

City

Dresden

State/Province

Saxony

ZIP/Postal Code

01307

Country

Germany

Facility Name

Local Institution - 413

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

Local Institution - 410

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

Local Institution - 406

City

Düsseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Local Institution - 415

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Local Institution - 404

City

Frankfurt am Main

ZIP/Postal Code

65929

Country

Germany

Facility Name

Local Institution - 412

City

Goch

ZIP/Postal Code

47574

Country

Germany

Facility Name

Local Institution - 405

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Local Institution - 408

City

Heilbronn

ZIP/Postal Code

74078

Country

Germany

Facility Name

Local Institution - 414

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Local Institution - 403

City

Keil

ZIP/Postal Code

24105

Country

Germany

Facility Name

Local Institution - 402

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

Local Institution - 409

City

Muenchen

ZIP/Postal Code

80804

Country

Germany

Facility Name

Local Institution - 411

City

München

ZIP/Postal Code

81675

Country

Germany

Facility Name

Local Institution - 407

City

Oldenburg

ZIP/Postal Code

26133

Country

Germany

Facility Name

Local Institution - 416

City

Schweiler

ZIP/Postal Code

52249

Country

Germany

Facility Name

Local Institution - 401

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Local Institution - 950

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Local Institution - 951

City

Galway

ZIP/Postal Code

ST46QG

Country

Ireland

Facility Name

Local Institution - 381

City

Beer Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Name

Local Institution - 380

City

Haifa

ZIP/Postal Code

35254

Country

Israel

Facility Name

Local Institution - 383

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Local Institution - 382

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Local Institution - 701

City

Alessandria

ZIP/Postal Code

15121

Country

Italy

Facility Name

Local Institution - 721

City

Bari

ZIP/Postal Code

70124

Country

Italy

Facility Name

Local Institution - 720

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Local Institution - 710

City

Cagliari

ZIP/Postal Code

O9126

Country

Italy

Facility Name

Local Institution - 702

City

Cremona

ZIP/Postal Code

26100

Country

Italy

Facility Name

Local Institution - 708

City

Firenze

ZIP/Postal Code

50129

Country

Italy

Facility Name

Local Institution - 712

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Local Institution - 716

City

Lecce

ZIP/Postal Code

73100

Country

Italy

Facility Name

Local Institution - 726

City

Milano

ZIP/Postal Code

20162

Country

Italy

Facility Name

Local Institution - 706

City

Milan

ZIP/Postal Code

20122

Country

Italy

Facility Name

Local Institution - 704

City

Monza

ZIP/Postal Code

20900

Country

Italy

Facility Name

Local Institution - 717

City

Naples

ZIP/Postal Code

80131

Country

Italy

Facility Name

Local Institution - 725

City

Naples

ZIP/Postal Code

80131

Country

Italy

Facility Name

Local Institution - 705

City

Orbassano (TO)

ZIP/Postal Code

10043

Country

Italy

Facility Name

Local Institution - 703

City

Palermo

ZIP/Postal Code

90146

Country

Italy

Facility Name

Local Institution - 719

City

Palermo

ZIP/Postal Code

90146

Country

Italy

Facility Name

Local Institution - 724

City

Pesaro

ZIP/Postal Code

31122

Country

Italy

Facility Name

Local Institution - 700

City

Reggio Calabria

ZIP/Postal Code

89100

Country

Italy

Facility Name

Local Institution - 709

City

Roma

ZIP/Postal Code

00161

Country

Italy

Facility Name

Local Institution - 714

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Local Institution - 723

City

Roma

ZIP/Postal Code

00189

Country

Italy

Facility Name

Local Institution - 722

City

Rome

ZIP/Postal Code

133

Country

Italy

Facility Name

Local Institution - 715

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Local Institution - 718

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Local Institution - 711

City

Udine

ZIP/Postal Code

33100

Country

Italy

Facility Name

Local Institution - 707

City

Varese

ZIP/Postal Code

21100

Country

Italy

Facility Name

Local Institution - 535

City

Busan

ZIP/Postal Code

49241

Country

Korea, Republic of

Facility Name

Local Institution - 533

City

Daegu

ZIP/Postal Code

700-721

Country

Korea, Republic of

Facility Name

Local Institution - 536

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Local Institution - 530

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Local Institution - 531

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

Local Institution - 532

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Local Institution - 750

City

Klaipeda

ZIP/Postal Code

5809

Country

Lithuania

Facility Name

Local Institution - 252

City

Huixquilucan de Degollado

ZIP/Postal Code

52763

Country

Mexico

Facility Name

Local Institution - 251

City

Mexico

ZIP/Postal Code

14080

Country

Mexico

Facility Name

Local Institution - 250

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Local Institution - 824

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Local Institution - 820

City

Gdansk

ZIP/Postal Code

80-211

Country

Poland

Facility Name

Local Institution - 822

City

Lodz

ZIP/Postal Code

93-510

Country

Poland

Facility Name

Local Institution - 821

City

Warsaw

ZIP/Postal Code

02-776

Country

Poland

Facility Name

Local Institution - 823

City

Wroclaw

ZIP/Postal Code

50-367

Country

Poland

Facility Name

Local Institution - 841

City

Coimbra

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Local Institution - 840

City

Lisboa

ZIP/Postal Code

1099-023

Country

Portugal

Facility Name

Local Institution - 843

City

Lisboa

ZIP/Postal Code

1150-314

Country

Portugal

Facility Name

Local Institution - 842

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Local Institution - 844

City

Porto

ZIP/Postal Code

4200

Country

Portugal

Facility Name

Local Institution - 971

City

Moscow

ZIP/Postal Code

125101

Country

Russian Federation

Facility Name

Local Institution - 970

City

Nizhniy Novgorod

ZIP/Postal Code

603005

Country

Russian Federation

Facility Name

Local Institution - 972

City

Saint Petersburg

ZIP/Postal Code

196022

Country

Russian Federation

Facility Name

Local Institution - 973

City

St Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

Facility Name

Local Institution - 872

City

Palma de Mallorca

State/Province

Baleares

ZIP/Postal Code

07198

Country

Spain

Facility Name

Local Institution - 869

City

Badalona (Barcelona)

ZIP/Postal Code

8916

Country

Spain

Facility Name

Local Institution - 871

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Local Institution - 870

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Local Institution - 873

City

Caceres

ZIP/Postal Code

10003

Country

Spain

Facility Name

Local Institution - 863

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Local Institution - 867

City

La Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Local Institution - 868

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Local Institution - 866

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Local Institution - 865

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Local Institution - 864

City

Oviedo

ZIP/Postal Code

33006

Country

Spain

Facility Name

Local Institution - 861

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Local Institution - 862

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Local Institution - 860

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Local Institution - 599

City

Beitou District, Taipei City

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Local Institution - 595

City

Niaosong District Kaohsiung City

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Local Institution - 596

City

Taichung, Northern Dist.

ZIP/Postal Code

404

Country

Taiwan

Facility Name

Local Institution - 597

City

Tainan, Taiana

ZIP/Postal Code

704

Country

Taiwan

Facility Name

Local Institution - 598

City

Taipei, Zhongzheng Dist.

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Local Institution - 653

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Local Institution - 650

City

Ankara

ZIP/Postal Code

06200

Country

Turkey

Facility Name

Local Institution - 651

City

Istanbul

ZIP/Postal Code

34662

Country

Turkey

Facility Name

Local Institution - 652

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

Facility Name

Local Institution - 904

City

Nottingham

State/Province

Nottinghamshire

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

Local Institution - 907

City

Boston

ZIP/Postal Code

PE21 9QS

Country

United Kingdom

Facility Name

Local Institution - 903

City

Brighton East Sussex

ZIP/Postal Code

BN2 5BE

Country

United Kingdom

Facility Name

Local Institution - 902

City

Canterbury Kent

ZIP/Postal Code

CT1 3NG

Country

United Kingdom

Facility Name

Local Institution - 905

City

London

ZIP/Postal Code

NW1 2PG

Country

United Kingdom

Facility Name

Local Institution - 901

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Local Institution - 908

City

London

ZIP/Postal Code

W12 0HS

Country

United Kingdom

Facility Name

Local Institution - 909

City

Maidstone

ZIP/Postal Code

ME16 9QQ

Country

United Kingdom

Facility Name

Local Institution - 900

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Local Institution - 906

City

Romford, Essex

ZIP/Postal Code

RM7 0AG

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

26785287

Citation

Roboz GJ, Montesinos P, Selleslag D, Wei A, Jang JH, Falantes J, Voso MT, Sayar H, Porkka K, Marlton P, Almeida A, Mohan S, Ravandi F, Garcia-Manero G, Skikne B, Kantarjian H. Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia. Future Oncol. 2016 Feb;12(3):293-302. doi: 10.2217/fon.15.326. Epub 2016 Jan 19.

Results Reference

background

PubMed Identifier

35960871

Citation

Dohner H, Wei AH, Roboz GJ, Montesinos P, Thol FR, Ravandi F, Dombret H, Porkka K, Sandhu I, Skikne B, See WL, Ugidos M, Risueno A, Chan ET, Thakurta A, Beach CL, Lopes de Menezes D. Prognostic impact of NPM1 and FLT3 mutations in patients with AML in first remission treated with oral azacitidine. Blood. 2022 Oct 13;140(15):1674-1685. doi: 10.1182/blood.2022016293.

Results Reference

derived

PubMed Identifier

35437111

Citation

Zhu J, Wu Q, Wang J, Niu T. Cost-effectiveness analysis of azacitidine maintenance therapy in patients with acute myeloid leukemia. Expert Rev Hematol. 2022 Apr;15(4):375-382. doi: 10.1080/17474086.2022.2061456. Epub 2022 May 11.

Results Reference

derived

PubMed Identifier

34995344

Citation

Roboz GJ, Ravandi F, Wei AH, Dombret H, Thol F, Voso MT, Schuh AC, Porkka K, La Torre I, Skikne B, Zhong J, Beach CL, Risueno A, Menezes DL, Ossenkoppele G, Dohner H. Oral azacitidine prolongs survival of patients with AML in remission independently of measurable residual disease status. Blood. 2022 Apr 7;139(14):2145-2155. doi: 10.1182/blood.2021013404.

Results Reference

derived

PubMed Identifier

34454540

Citation

Ravandi F, Roboz GJ, Wei AH, Dohner H, Pocock C, Selleslag D, Montesinos P, Sayar H, Musso M, Figuera-Alvarez A, Safah H, Tse W, Sohn SK, Hiwase D, Chevassut T, Pierdomenico F, La Torre I, Skikne B, Bailey R, Zhong J, Beach CL, Dombret H. Management of adverse events in patients with acute myeloid leukemia in remission receiving oral azacitidine: experience from the phase 3 randomized QUAZAR AML-001 trial. J Hematol Oncol. 2021 Aug 28;14(1):133. doi: 10.1186/s13045-021-01142-x.

Results Reference

derived

PubMed Identifier

33369355

Citation

Wei AH, Dohner H, Pocock C, Montesinos P, Afanasyev B, Dombret H, Ravandi F, Sayar H, Jang JH, Porkka K, Selleslag D, Sandhu I, Turgut M, Giai V, Ofran Y, Kizil Cakar M, Botelho de Sousa A, Rybka J, Frairia C, Borin L, Beltrami G, Cermak J, Ossenkoppele GJ, La Torre I, Skikne B, Kumar K, Dong Q, Beach CL, Roboz GJ; QUAZAR AML-001 Trial Investigators. Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission. N Engl J Med. 2020 Dec 24;383(26):2526-2537. doi: 10.1056/NEJMoa2004444.

Results Reference

derived

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

Learn more about this trial

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

We'll reach out to this number within 24 hrs