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Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML

Primary Purpose

Myeloid Leukemia, Chronic, Accelerated Phase, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

dasatinib

About this trial

This is an interventional treatment trial for Myeloid Leukemia, Chronic, Accelerated Phase focused on measuring Accelerated Phase Chronic Myeloid Leukemia, Lymphoid Blast Phase Chronic Myeloid Leukemia, Myeloid Blast Phase Chronic Myeloid Leukemia, Philadelphia Positive Acute Lymphoblastic Leukemia

Eligibility Criteria

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Patients with Philadelphia-Positive (Ph+) (or BCR/ABL+) accelerated phase chronic myeloid leukemia, Ph+ (or BCR/ABL+) blast phase chronic myeloid leukemia, or Ph+ (or BCR/ABL+) acute lymphoblastic leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate Men and women, 18 years of age or older Adequate hepatic function Adequate renal function Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2 Exclusion Criteria: Women who are pregnant or breastfeeding A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy Uncontrolled or significant cardiovascular disease Medications that increase bleeding risk Medications that change heart rhythms Dementia or altered mental status that would prohibit the understanding or rendering of informed consent History of significant bleeding disorder unrelated to CML Concurrent incurable malignancy other than CML Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy Prior therapy with BMS-35425 Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

dasatinib Twice a Day (BID)

dasatinib Once a Day (QD)

Arm Description

70 mg dasatinib twice a day (BID)

140 mg dasatinib once a day (QD)

Outcomes

Primary Outcome Measures

Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population

MaHR defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm^3; platelets ≥ 100,000/mm^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; <5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule. Percentage: number of participants with MaHR/number of randomized participants.

Secondary Outcome Measures

Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population

A MaHR was defined as a participant having either CHR or NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule. Percent: number of participants with MaHR /number of participants randomized.

Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population

MaHR was defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm^3; platelets ≥ 100,000/mm^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; <5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one parameter of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule.. Percentage: participants with MaHR/randomized participants.

Median Time to Major Hematologic Response (MaHR) - Randomized Population

A participants' time to MaHR was defined as the time from the first dosing date until criteria are first met for CHR or NEL, whichever occurred first. Non-responders were censored at the maximum of the date of last hematologic or cytogenetic assessment. Median time was measured in months.

Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study

MaHR was defined by either CHR or no evidence of leukemia NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. Median duration was measured in months.

Percent of Participants With Overall Hematologic Response - Randomized Population

Overall Hematologic Response (OHR) was defined as CHR, NEL or minor hematologic response (MiHR). CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. MiHR defined as: < 15% blasts in BM and in PB; < 30% blasts + promyelocytes in BM and PB; < 20% basophils in PB; No extra-medullary disease other than spleen and liver. Percentage: participants with OHR/ randomized participants.

Number of Participants With Best Confirmed Hematologic Response, Major Hematologic Response (MaHR) and Overall Hematologic Response - Randomized Population

Type of hematologic response: CHR defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and <100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. Minor Hematologic Response (MiHR): <15% blasts in BM and in PB; < 30% blasts + promyelocytes in BM and PB; < 20% basophils in PB; No extra-medullary disease other than spleen and liver. Major hematologic response (MaHR ) was CHR or NEL. Overall hematologic response was CHR or NEL or MiHR.

Percent of Participants With Major Cytogenetic Response (MCyR) - Randomized Population

Cytogenetic assessments were performed only for the first 2 years of study. CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): 1% to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: 36% to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: 66% to 95% Ph+ cells in metaphase in BM; No cytogenetic response: 96% to 100% Ph+ cells in metaphase in BM; Major cytogenetic response (MCyR) was defined as CCyR or PCyR. Percentage: number of participants with MCyR and denominator is number of randomized participants.

Number of Participants With Best Cytogenic Response (CyR) - Randomized Population

Median Progression Free Survival (PFS) - Randomized Population

PFS was defined as: Time from randomization until any of the following: Progression of disease (per investigator), or death. For those with blast phase CML or Ph+ ALL, disease progression was: loss of OHR; no decrease from on-study baseline percent blasts in PB or BM on all assessments over a 4-week period after starting maximum dose; absolute increase of at least 50% in PB blast count over a 2-week period after starting maximum dose. For those with accelerated phase CML: the list above also included: Development of blast phase CML at any time after initiation of therapy and development of extra-medullary sites other than spleen or liver. Participants who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. Median duration was measured in months.

Median Overall Survival (OS) - Randomized Population

OS was defined as time from randomization until date of death. Participants who had not died or who were lost to follow-up were censored on the last date on which the participant was known to be alive. Median duration was measured in months.

Progression Free Survival (PFS) and Overall Survival (OS) at 24, 36, 48, and 60 Months - Randomized Population

PFS was defined as time from randomization until any of the following: Progression of disease (per investigator), or death. For those with blast phase CML or Ph+ ALL, disease progression was: loss of OHR; no decrease from on-study baseline percent blasts in PB or BM on all assessments over a 4-week period after starting maximum dose; absolute increase of at least 50% in PB blast count over a 2-week period after starting maximum dose. For those with accelerated phase CML: the list above also included: Development of blast phase CML at any time after initiation of therapy and development of extra-medullary sites other than spleen or liver. Participants who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. OS was defined as time from randomization until date of death. Participants who had not died or were lost to follow-up were censored on the last date they were known to be alive. Median duration was measured in months.

Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation and Drug-related Fluid Retention AEs, up to Year 7 in Treated Participants

With protocol Amendment 6, the duration of the study was extended for 2 additional years (7 years total) for participants who continued to have clinical benefit and no feasible alternate access to dasatinib. However, after Year 5 the requirement to follow participants for survival and to collect other efficacy data was removed from the protocol for the remainder of the study. Only AEs and SAEs were collected up to Year 7. On-study AEs and SAEs were graded by severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The investigator AE terms were coded and grouped by preferred term and system organ class using the Medical Dictionary for Regulatory Activities (MedDRA), version 16.0.

Number of Participants With Normal Baseline Versus Worst Grade 3/4 Hematology Laboratory Abnormalities up to Year 2 in Treated Participants

Laboratory abnormalities were graded according to the National Cancer Institute Common Terminology Criteria (NCI CTC) version 3.0. CTC Grade 3 and 4 criteria are defined as follows: White blood cells (WBC): Grade (Gr) 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. Absolute neutrophil count (ANC): Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Baseline was laboratory value obtained within 2 weeks prior to randomization.

Number of Participants With Grade 4 Myelosuppression Determined From Hematology Evaluations

Laboratory abnormalities were graded according to the National Cancer Institute Common Terminology Criteria (NCI CTC) Version 3.0. Grade 4 hematology evaluations used to determine myelosuppression included: WBC: <1.0*10^9/L. ANC: <0.5*10^9/L. Platelet count <25.0 to 10^9/L.

Number of Participants With Normal Baseline Versus Worst Grade 3/4 Biochemistry Laboratory Abnormalities up to Year 2 in Treated Participants

Laboratory abnormalities were graded according to the NCI CTC version 3.0. Grade 3 and 4 criteria were defined as follows: Upper limit of normal (ULN). Alanine transaminase (ALT) Grade (Gr) 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Aspartate aminotransferase (AST) Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. Serum creatinine (H) Gr 3: >3.0 to 6.0*ULN; Gr 4: >6.0*ULN. Calcium (L) Gr3: 6.0-7.0; Gr 4: <6.0 mg/dL; Phosphorus (L): Gr 3: <2.0 - 1.0 mg/dL , Gr 4: <1.0 mg/dL. Non-hematologic laboratory results were not collected beyond Year 2. Baseline values were obtained within 2 weeks prior to randomization.

Number of Participants With Changes From Baseline in QT Interval Corrected With Fridericia Formula (QTcF) up to Year 2 in Treated Participants

A12-lead electrocardiogram (ECG) was obtained at baseline (baseline=within 2 weeks prior to randomization) and once between Days 8 and 29. Additional ECGs were done at the Investigator's discretion. ECGs were read centrally. The QT interval corrected with Fridericia formula is presented with categories of changes from baseline (BL) in milliseconds (msec).

Number of Participants With Maximal QTcF Intervals up to Year 2 in Treated Participants

A12-lead ECG was obtained at baseline (baseline=within 2 weeks prior to randomization) and once between Day 8 and 29. Additional ECGs were done at the Investigator's discretion. ECGs were read centrally. QT Interval corrected with Fridericia formula was measured in msec.

Full Information

NCT ID

NCT00123487

First Posted

July 21, 2005

Last Updated

October 30, 2014

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00123487

Brief Title

Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML

Official Title

A Randomized Two-Arm, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects With Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).

6. Conditions and Keywords

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

Myeloid Leukemia, Chronic, Accelerated Phase, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

Keywords

Accelerated Phase Chronic Myeloid Leukemia, Lymphoid Blast Phase Chronic Myeloid Leukemia, Myeloid Blast Phase Chronic Myeloid Leukemia, Philadelphia Positive Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

638 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dasatinib Twice a Day (BID)

Arm Type

Experimental

Arm Description

70 mg dasatinib twice a day (BID)

Arm Title

dasatinib Once a Day (QD)

Arm Type

Experimental

Arm Description

140 mg dasatinib once a day (QD)

Intervention Type

Drug

Intervention Name(s)

dasatinib

Other Intervention Name(s)

Sprycel, BMS-354825

Intervention Description

Tablets, Oral, 70 mg BID, indefinitely, survival study

Intervention Type

Drug

Intervention Name(s)

dasatinib

Other Intervention Name(s)

Sprycel, BMS-354825

Intervention Description

Tablets, Oral, 140 mg QD, indefinitely, survival study

Primary Outcome Measure Information:

Title

Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population

Description

Time Frame

Randomization up to 6 months

Secondary Outcome Measure Information:

Title

Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population

Description

Time Frame

Randomization up to 2 years

Title

Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population

Description

Time Frame

Randomization up to 2 years

Title

Median Time to Major Hematologic Response (MaHR) - Randomized Population

Description

Time Frame

Day 1 up to 6 months (time of primary endpoint), 2 years

Title

Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study

Description

Time Frame

Day 1 up to 5 years

Title

Percent of Participants With Overall Hematologic Response - Randomized Population

Description

Time Frame

Randomization up to 6 Months, 2 Years

Title

Number of Participants With Best Confirmed Hematologic Response, Major Hematologic Response (MaHR) and Overall Hematologic Response - Randomized Population

Description

Time Frame

Randomization up to 6 months, 2 years

Title

Percent of Participants With Major Cytogenetic Response (MCyR) - Randomized Population

Description

Time Frame

Randomization up to 6 Months, 2 Years

Title

Number of Participants With Best Cytogenic Response (CyR) - Randomized Population

Description

Time Frame

Randomization up to 6 Months, 2 Years

Title

Median Progression Free Survival (PFS) - Randomized Population

Description

Time Frame

Randomization up to 5 Years

Title

Median Overall Survival (OS) - Randomized Population

Description

Time Frame

Randomization up to 5 Years

Title

Progression Free Survival (PFS) and Overall Survival (OS) at 24, 36, 48, and 60 Months - Randomized Population

Description

Time Frame

24 months, 36 months, 48 months, 60 months

Title

Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation and Drug-related Fluid Retention AEs, up to Year 7 in Treated Participants

Description

Time Frame

Day 1 to Year 7

Title

Number of Participants With Normal Baseline Versus Worst Grade 3/4 Hematology Laboratory Abnormalities up to Year 2 in Treated Participants

Description

Time Frame

Baseline to Year 2

Title

Number of Participants With Grade 4 Myelosuppression Determined From Hematology Evaluations

Description

Time Frame

Day 1 up to Year 7

Title

Number of Participants With Normal Baseline Versus Worst Grade 3/4 Biochemistry Laboratory Abnormalities up to Year 2 in Treated Participants

Description

Time Frame

Baseline to Year 2

Title

Number of Participants With Changes From Baseline in QT Interval Corrected With Fridericia Formula (QTcF) up to Year 2 in Treated Participants

Description

Time Frame

Baseline to Year 2

Title

Number of Participants With Maximal QTcF Intervals up to Year 2 in Treated Participants

Description

Time Frame

Baseline up to Year 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

University Of Alabama At Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Loma Linda University Cancer Center

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

Facility Name

Ucla Dept. Of Medicine

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Washington Cancer Institute At Washington Hospital Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

University Of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Emory University School Of Medicine

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

The University Of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637-1463

Country

United States

Facility Name

Indiana University Cancer Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

University Of Kentucky

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536-0098

Country

United States

Facility Name

University Of Maryland

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201-1595

Country

United States

Facility Name

Dana Faber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Karmanos Cancer Center

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Washington University School Of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110-1093

Country

United States

Facility Name

Nebraska Methodist Hospital

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Devetten, Marcel

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198-7680

Country

United States

Facility Name

The Cancer Center At Hackensack University Medical Center

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

The Cancer Institute Of New Jersey

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

Facility Name

New York Presbyterian Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

The University Of North Carolina At Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7305

Country

United States

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Oregon Health & Sci Univ

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Western Pennsylvania Cancer Institute

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

Sarah Cannon Research Institute

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

The University Of Texas Md Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Seattle Cancer Care Alliance

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Local Institution

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1280

Country

Argentina

Facility Name

Local Institution

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Local Institution

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Local Institution

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

SA 5000

Country

Australia

Facility Name

Local Institution

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Local Institution

City

Perth

State/Province

Western Australia

ZIP/Postal Code

WA 6000

Country

Australia

Facility Name

Local Institution

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Local Institution

City

B-leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Local Institution

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Local Institution

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Local Institution

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

Local Institution

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

Local Institution

City

Curitiba

State/Province

Parana

ZIP/Postal Code

80060-900

Country

Brazil

Facility Name

Local Institution

City

Campinas

State/Province

Sao Paulo

ZIP/Postal Code

13083-970

Country

Brazil

Facility Name

Local Institution

City

Morumbi

State/Province

Sao Paulo

ZIP/Postal Code

05652-000

Country

Brazil

Facility Name

Local Institution

City

Rio De Janeiro

ZIP/Postal Code

20230-130

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

Local Institution

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Local Institution

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Local Institution

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

Local Institution

City

Brno

ZIP/Postal Code

62500

Country

Czech Republic

Facility Name

Local Institution

City

Prague 2

ZIP/Postal Code

128 20

Country

Czech Republic

Facility Name

Local Institution

City

Aarhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Local Institution

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Local Institution

City

Odense C

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Local Institution

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

Facility Name

Local Institution

City

Caen Cedex

ZIP/Postal Code

14033

Country

France

Facility Name

Local Institution

City

Creteil Cedex

ZIP/Postal Code

94010

Country

France

Facility Name

Local Institution

City

Grenoble Cedex 9

ZIP/Postal Code

38043

Country

France

Facility Name

Local Institution

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Local Institution

City

Lyon Cedex

ZIP/Postal Code

69437

Country

France

Facility Name

Local Institution

City

Marseille Cedex 9

ZIP/Postal Code

13273

Country

France

Facility Name

Local Institution

City

Nantes

ZIP/Postal Code

44000

Country

France

Facility Name

Local Institution

City

Paris Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

Local Institution

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Local Institution

City

Poitiers Cedex

ZIP/Postal Code

86021

Country

France

Facility Name

Local Institution

City

Strasbourg Cedex

ZIP/Postal Code

67091

Country

France

Facility Name

Local Institution

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Local Institution

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Local Institution

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Local Institution

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Local Institution

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Local Institution

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

Local Institution

City

Athens

ZIP/Postal Code

11523

Country

Greece

Facility Name

Local Institution

City

Budapest

ZIP/Postal Code

1135

Country

Hungary

Facility Name

Local Institution

City

Dublin

Country

Ireland

Facility Name

Local Institution

City

Ramat-gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Local Institution

City

Bari

ZIP/Postal Code

70124

Country

Italy

Facility Name

Local Institution

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Local Institution

City

Monza

ZIP/Postal Code

20052

Country

Italy

Facility Name

Local Institution

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Local Institution

City

Orbassano (to)

ZIP/Postal Code

10043

Country

Italy

Facility Name

Local Institution

City

Roma

ZIP/Postal Code

00144

Country

Italy

Facility Name

Local Institution

City

Jeollanam-do

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

137-040

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Local Institution

City

Rotterdam

ZIP/Postal Code

3075 EA

Country

Netherlands

Facility Name

Local Institution

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

Facility Name

Local Institution

City

Jesus Maria

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Local Institution

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Local Institution

City

Quezon City

ZIP/Postal Code

1102

Country

Philippines

Facility Name

Local Institution

City

Gdansk

ZIP/Postal Code

80211

Country

Poland

Facility Name

Local Institution

City

Katowice

ZIP/Postal Code

40032

Country

Poland

Facility Name

Local Institution

City

Krakow

ZIP/Postal Code

31501

Country

Poland

Facility Name

Local Institution

City

Lodz

ZIP/Postal Code

93510

Country

Poland

Facility Name

Local Institution

City

Lublin

ZIP/Postal Code

20950

Country

Poland

Facility Name

Local Institution

City

Warsaw

ZIP/Postal Code

02097

Country

Poland

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

125167

Country

Russian Federation

Facility Name

Local Institution

City

St.petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Local Institution

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

Local Institution

City

Bloemfontein

State/Province

Free State

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Local Institution

City

Groenkloof

State/Province

Gauteng

ZIP/Postal Code

0181

Country

South Africa

Facility Name

Local Institution

City

Parktown

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Local Institution

City

Observatory

State/Province

Western Cape

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Local Institution

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

Local Institution

City

Lund

ZIP/Postal Code

22185

Country

Sweden

Facility Name

Local Institution

City

Stockholm

ZIP/Postal Code

17176

Country

Sweden

Facility Name

Local Institution

City

Umea

ZIP/Postal Code

90185

Country

Sweden

Facility Name

Local Institution

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

Facility Name

Local Institution

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Local Institution

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Local Institution

City

Taipei

Country

Taiwan

Facility Name

Local Institution

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Local Institution

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Local Institution

City

London

State/Province

Greater London

ZIP/Postal Code

W12 ONN

Country

United Kingdom

Facility Name

Local Institution

City

Glasgow

State/Province

Scotland

ZIP/Postal Code

G12 OXB

Country

United Kingdom

Facility Name

Local Institution

City

Newcastle

State/Province

Tyne And Wear

ZIP/Postal Code

NE2 4HH

Country

United Kingdom

Facility Name

Local Institution

City

Edinburgh

ZIP/Postal Code

EH8 9RS

Country

United Kingdom

Facility Name

Local Institution

City

Liverpool

ZIP/Postal Code

L7 8XP

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

16960978

Citation

Chu SC, Tang JL, Li CC. Dasatinib in chronic myelogenous leukemia. N Engl J Med. 2006 Sep 7;355(10):1062-3; author reply 1063-4. No abstract available.

Results Reference

result

PubMed Identifier

20131302

Citation

Lilly MB, Ottmann OG, Shah NP, Larson RA, Reiffers JJ, Ehninger G, Muller MC, Charbonnier A, Bullorsky E, Dombret H, Brigid Bradley-Garelik M, Zhu C, Martinelli G. Dasatinib 140 mg once daily versus 70 mg twice daily in patients with Ph-positive acute lymphoblastic leukemia who failed imatinib: Results from a phase 3 study. Am J Hematol. 2010 Mar;85(3):164-70. doi: 10.1002/ajh.21615.

Results Reference

derived

PubMed Identifier

19369231

Citation

Kantarjian H, Cortes J, Kim DW, Dorlhiac-Llacer P, Pasquini R, DiPersio J, Muller MC, Radich JP, Khoury HJ, Khoroshko N, Bradley-Garelik MB, Zhu C, Tallman MS. Phase 3 study of dasatinib 140 mg once daily versus 70 mg twice daily in patients with chronic myeloid leukemia in accelerated phase resistant or intolerant to imatinib: 15-month median follow-up. Blood. 2009 Jun 18;113(25):6322-9. doi: 10.1182/blood-2008-11-186817. Epub 2009 Apr 15.

Results Reference

derived

Links:

URL

http://www.bms.com/studyconnect/Pages/home.aspx

Description

BMS clinical trial educational resource

Learn more about this trial

Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML

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Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML

Myeloid Leukemia, Chronic, Accelerated Phase, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial