Back to resultsStudy of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib (DASCERN)
Primary Purpose
Chronic Phase Chronic Myeloid Leukemia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Imatinib
Dasatinib
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Phase Chronic Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria:
- Chronic Phase (CP)-CML Ph+ patients with complete hematologic response (CHR) but without one log BCR-ABL reduction (BCR-ABL level >10% IS) 3 months of imatinib 400mg treatment. (Imatinib transient dose adjustments due to Adverse Event (AEs) are allowed with a maximum of 2 weeks interruption of treatment with imatinib (cumulative) within the 3 month period before randomization). Imatinib monotherapy must have been started within 6 months of CP-CML diagnosis (Ph + /BCR-ABL detection)
- Currently tolerating imatinib 400mg QD. Patients with prior imatinib treatment interruption or dose reductions are required to be on treatment with 400 mg imatinib for two weeks immediately prior to randomization to ensure tolerance to imatinib
- Eastern Co-Operative Group (ECOG) performance status = 0 - 2
- Adequate renal function defined as serum creatinine ≤3 times the institutional upper limit of normal (ULN)
- Adequate hepatic function defined as: total bilirubin ≤2.0 times the institutional ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the institutional ULN
Exclusion Criteria:
- Previous diagnosis of accelerated phase or blast crisis
- Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases at baseline bone marrow cytogenetic test, unless the same abnormalities were present at diagnosis. Patients with no evidence of clonal evolution, including those patients whose cytogenetic testing fails or bone marrow aspiration is a dry tap at 3 months, are eligible for the study
- Subjects with less than CHR after 3 months of imatinib treatment or lost CHR after initial achievement
- Documented T315I/A, F317L, or V299L mutations (if already available - not required for screening)
- A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
Sites / Locations
- Local Institution - 0004
- Local Institution - 0006
- University Of Southern California University Hospital
- Local Institution - 0110
- Local Institution - 0112
- Local Institution - 0009
- Local Institution - 0078
- Local Institution - 0089
- Northwestern University
- Carle Cancer Center
- Northern Indiana Cancer Research Consortium
- Franciscan St. Francis Health
- University Of Iowa
- Local Institution - 0010
- Local Institution - 0002
- Hillman Cancer Center
- Local Institution - 0001
- Michael E Debakey VAMC
- Institute of Oncology Hematology Biomedical Research
- Edwards Comprehensive Cancer Center
- Local Institution - 0005
- Local Institution - 0093
- Local Institution - 0080
- Local Institution - 0049
- Local Institution - 0051
- Local Institution - 0057
- Local Institution - 0100
- Local Institution - 0026
- Local Institution - 0022
- Local Institution
- Local Institution - 0043
- Local Institution - 0024
- Local Institution - 0023
- Local Institution - 0065
- Local Institution - 0099
- Local Institution
- Local Institution - 0083
- Local Institution
- Local Institution - 0063
- Local Institution
- Local Institution - 0059
- Local Institution - 0062
- Local Institution - 0058
- Local Institution - 0111
- Local Institution - 0020
- Local Institution - 0071
- Local Institution - 0086
- Local Institution - 0070
- Local Institution - 0103
- Local Institution - 0082
- Local Institution - 0074
- Local Institution - 0084
- Local Institution - 0102
- Local Institution - 0073
- Local Institution - 0077
- Local Institution - 0094
- Local Institution - 0088
- Local Institution - 0101
- Local Institution - 0075
- Local Institution - 0069
- Local Institution - 0072
- Local Institution - 0076
- Local Institution - 0096
- Local Institution - 0032
- Local Institution
- Local Institution
- Local Institution
- Local Institution - 0067
- Local Institution - 0045
- Local Institution - 0041
- Local Institution
- Local Institution
- Local Institution - 0038
- Local Institution
- Local Institution - 0104
- Local Institution - 0106
- Local Institution
- Local Institution
- Local Institution
- Local Institution - 0027
- Local Institution - 0046
- Local Institution
- Local Institution - 0025
- Local Institution - 0021
- Local Institution - 0033
- Local Institution - 0039
- Local Institution - 0050
- Local Institution - 0040
- Local Institution - 0048
- Local Institution - 0047
- Local Institution - 0098
- Local Institution - 0064
- Local Institution - 0017
- Local Institution - 0018
- Local Institution - 0015
- Local Institution - 0012
- Local Institution - 0013
- Local Institution - 0011
- Local Institution - 0055
- Local Institution
- Local Institution - 0052
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arm 1: Imatinib (≥400 mg)
Arm 2: Dasatinib (100 mg)
Arm Description
Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months
Dasatinib 100 mg tablet by mouth QD up to 60 months
Outcomes
Primary Outcome Measures
Percentage of Patients Achieving Major Molecular Response (MMR) After 12 Months of CML Treatment
Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR; N/A = not applicable. 95% CI is Clopper-Pearson(Exact) two-sided 95% confidence intervals.
P-value is based on Cochran-Mantel-Haenszel (CMH) test stratified by Sokal score(high, intermediate, low, and unknown) and time between 3 month molecular analysis and randomization (<=4 weeks vs >4 weeks).
Secondary Outcome Measures
Median Time to Major Molecular Response (MMR)
Median Time to Major Molecular Response (MMR) is the time between randomization date and first date that MMR (or MR4.5) criteria are satisfied. Participants who do not achieve MMR (or MR4.5) will be censored.
Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR.
Time to Molecular Response (MR)^4.5
Time to Molecular Response (MR)^4.5 is the time between randomization date and first date that MMR (or MR4.5) criteria are satisfied. Participants who do not achieve MMR (or MR4.5) will be censored.
MR4.5 is defined as a 4.5-log reduction in BCR-ABL transcript from the standardized baseline (0.0032% IS, either detectable disease <= 0.0032% BCR-ABL (IS) or undetectable disease in cDNA (in same volume used for BCR-ABL) with >= 32,000 ABL transcripts.
Progression Free Survival (PFS)
PFS is the time from randomization date to progression date or death date, whichever occurs first. Participants who neither progress nor die will be censored.
Progression is defined as the following, meeting the criteria for accelerated or blast crisis CML are met at any time or death from any cause during treatment.
Accelerated phase of CML:
The presence of ≥15%, but < 30% blasts in the blood or bone marrow
At least 30% blasts plus promyelocytes in the blood or bone marrow
At least 20% peripheral basophils
Thrombocytopenia (fewer than 100,000 platelets/mm3) unrelated to treatment.
Blast phase of CML
At least 30% blasts in the blood or bone marrow
Extramedullary involvement (e.g., chloromas), but not hepatosplenomegaly
Overall Survival (OS)
OS is the time from randomization date to death date. Participants who have not died will be censored on the last date they are known to be alive.
Full Information
NCT ID
NCT01593254
First Posted
May 4, 2012
Last Updated
May 30, 2023
Sponsor
Bristol-Myers Squibb
Collaborators
ICON Clinical Research, PPD, Molecular MD, MultiPharma, Q2 Solutions, Donald E. Morisky, MD Anderson Symptom Inventory (MDASI-CML), OBiS, Inc, Steering Committee
1. Study Identification
Unique Protocol Identification Number
NCT01593254
Brief Title
Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib
Acronym
DASCERN
Official Title
An Open Label, Randomized (2:1) Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia Who Have Not Achieved an Optimal Response to 3 Months of Therapy With 400 mg Imatinib
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 12, 2012 (Actual)
Primary Completion Date
November 8, 2017 (Actual)
Study Completion Date
April 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
ICON Clinical Research, PPD, Molecular MD, MultiPharma, Q2 Solutions, Donald E. Morisky, MD Anderson Symptom Inventory (MDASI-CML), OBiS, Inc, Steering Committee
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Phase Chronic Myeloid Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
262 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Imatinib (≥400 mg)
Arm Type
Active Comparator
Arm Description
Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months
Arm Title
Arm 2: Dasatinib (100 mg)
Arm Type
Active Comparator
Arm Description
Dasatinib 100 mg tablet by mouth QD up to 60 months
Intervention Type
Drug
Intervention Name(s)
Imatinib
Other Intervention Name(s)
Gleevec, Glivec
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
Sprycel
Primary Outcome Measure Information:
Title
Percentage of Patients Achieving Major Molecular Response (MMR) After 12 Months of CML Treatment
Description
Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR; N/A = not applicable. 95% CI is Clopper-Pearson(Exact) two-sided 95% confidence intervals.
P-value is based on Cochran-Mantel-Haenszel (CMH) test stratified by Sokal score(high, intermediate, low, and unknown) and time between 3 month molecular analysis and randomization (<=4 weeks vs >4 weeks).
Time Frame
At 12 months after Day 1 initiation of 1st line treatment with imatinib or imatinib at any dose, after less than optimal response to first-line imatinib.
Secondary Outcome Measure Information:
Title
Median Time to Major Molecular Response (MMR)
Description
Median Time to Major Molecular Response (MMR) is the time between randomization date and first date that MMR (or MR4.5) criteria are satisfied. Participants who do not achieve MMR (or MR4.5) will be censored.
Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR.
Time Frame
From randomization to study completion. Approximately 115 months
Title
Time to Molecular Response (MR)^4.5
Description
Time to Molecular Response (MR)^4.5 is the time between randomization date and first date that MMR (or MR4.5) criteria are satisfied. Participants who do not achieve MMR (or MR4.5) will be censored.
MR4.5 is defined as a 4.5-log reduction in BCR-ABL transcript from the standardized baseline (0.0032% IS, either detectable disease <= 0.0032% BCR-ABL (IS) or undetectable disease in cDNA (in same volume used for BCR-ABL) with >= 32,000 ABL transcripts.
Time Frame
From randomization to study completion. Approximately 115 months
Title
Progression Free Survival (PFS)
Description
PFS is the time from randomization date to progression date or death date, whichever occurs first. Participants who neither progress nor die will be censored.
Progression is defined as the following, meeting the criteria for accelerated or blast crisis CML are met at any time or death from any cause during treatment.
Accelerated phase of CML:
The presence of ≥15%, but < 30% blasts in the blood or bone marrow
At least 30% blasts plus promyelocytes in the blood or bone marrow
At least 20% peripheral basophils
Thrombocytopenia (fewer than 100,000 platelets/mm3) unrelated to treatment.
Blast phase of CML
At least 30% blasts in the blood or bone marrow
Extramedullary involvement (e.g., chloromas), but not hepatosplenomegaly
Time Frame
From randomization to study completion. Approximately 115 months
Title
Overall Survival (OS)
Description
OS is the time from randomization date to death date. Participants who have not died will be censored on the last date they are known to be alive.
Time Frame
From randomization to study completion. Approximately 115 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic Phase (CP)-CML Ph+ patients with complete hematologic response (CHR) but without one log BCR-ABL reduction (BCR-ABL level >10% IS) 3 months of imatinib 400mg treatment. (Imatinib transient dose adjustments due to Adverse Event (AEs) are allowed with a maximum of 2 weeks interruption of treatment with imatinib (cumulative) within the 3 month period before randomization). Imatinib monotherapy must have been started within 6 months of CP-CML diagnosis (Ph + /BCR-ABL detection)
Currently tolerating imatinib 400mg QD. Patients with prior imatinib treatment interruption or dose reductions are required to be on treatment with 400 mg imatinib for two weeks immediately prior to randomization to ensure tolerance to imatinib
Eastern Co-Operative Group (ECOG) performance status = 0 - 2
Adequate renal function defined as serum creatinine ≤3 times the institutional upper limit of normal (ULN)
Adequate hepatic function defined as: total bilirubin ≤2.0 times the institutional ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the institutional ULN
Exclusion Criteria:
Previous diagnosis of accelerated phase or blast crisis
Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases at baseline bone marrow cytogenetic test, unless the same abnormalities were present at diagnosis. Patients with no evidence of clonal evolution, including those patients whose cytogenetic testing fails or bone marrow aspiration is a dry tap at 3 months, are eligible for the study
Subjects with less than CHR after 3 months of imatinib treatment or lost CHR after initial achievement
Documented T315I/A, F317L, or V299L mutations (if already available - not required for screening)
A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
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
Local Institution - 0004
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Local Institution - 0006
City
Fontana
State/Province
California
ZIP/Postal Code
92335
Country
United States
Facility Name
University Of Southern California University Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Local Institution - 0110
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Local Institution - 0112
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Local Institution - 0009
City
Vallejo
State/Province
California
ZIP/Postal Code
94589-2441
Country
United States
Facility Name
Local Institution - 0078
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Local Institution - 0089
City
Southington
State/Province
Connecticut
ZIP/Postal Code
06489
Country
United States
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Northern Indiana Cancer Research Consortium
City
Crown Point
State/Province
Indiana
ZIP/Postal Code
46307
Country
United States
Facility Name
Franciscan St. Francis Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University Of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Local Institution - 0010
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Local Institution - 0002
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Local Institution - 0001
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1625
Country
United States
Facility Name
Michael E Debakey VAMC
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Institute of Oncology Hematology Biomedical Research
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Edwards Comprehensive Cancer Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Local Institution - 0005
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Local Institution - 0093
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
0
Country
Argentina
Facility Name
Local Institution - 0080
City
Ramos Mejia
State/Province
Buenos Aires
ZIP/Postal Code
1221
Country
Argentina
Facility Name
Local Institution - 0049
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Local Institution - 0051
City
Buenos Aires
ZIP/Postal Code
4102-4200
Country
Argentina
Facility Name
Local Institution - 0057
City
Buenos Aires
ZIP/Postal Code
C1114AAN
Country
Argentina
Facility Name
Local Institution - 0100
City
Corrientes
ZIP/Postal Code
CP3400
Country
Argentina
Facility Name
Local Institution - 0026
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Local Institution - 0022
City
Wels
State/Province
Upper Austria
ZIP/Postal Code
4600
Country
Austria
Facility Name
Local Institution
City
Fuerstenfeld
ZIP/Postal Code
8280
Country
Austria
Facility Name
Local Institution - 0043
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution - 0024
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Local Institution - 0023
City
Wien
ZIP/Postal Code
1090 Wien
Country
Austria
Facility Name
Local Institution - 0065
City
Brugge
ZIP/Postal Code
B-8000
Country
Belgium
Facility Name
Local Institution - 0099
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Facility Name
Local Institution
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Local Institution - 0083
City
Goiania
State/Province
Goias
ZIP/Postal Code
74605-020
Country
Brazil
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80060-900
Country
Brazil
Facility Name
Local Institution - 0063
City
Campinas
State/Province
SAO Paulo
ZIP/Postal Code
13083-970
Country
Brazil
Facility Name
Local Institution
City
Ribeirão Preto
State/Province
SAO Paulo
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Local Institution - 0059
City
São Paulo
State/Province
SAO Paulo
ZIP/Postal Code
08270-070
Country
Brazil
Facility Name
Local Institution - 0062
City
Rio de Janeiro
ZIP/Postal Code
20211-030
Country
Brazil
Facility Name
Local Institution - 0058
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Local Institution - 0111
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Local Institution - 0020
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Local Institution - 0071
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Local Institution - 0086
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Local Institution - 0070
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Local Institution - 0103
City
Shenzhen
State/Province
Guandong
ZIP/Postal Code
518035
Country
China
Facility Name
Local Institution - 0082
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Local Institution - 0074
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Local Institution - 0084
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
150010
Country
China
Facility Name
Local Institution - 0102
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Local Institution - 0073
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Local Institution - 0077
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Facility Name
Local Institution - 0094
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
Local Institution - 0088
City
Xian
State/Province
Shan3xi
ZIP/Postal Code
710000
Country
China
Facility Name
Local Institution - 0101
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Local Institution - 0075
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Local Institution - 0069
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
Local Institution - 0072
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Local Institution - 0076
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Local Institution - 0096
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Local Institution - 0032
City
Brno
State/Province
Czech Republic
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Local Institution
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Local Institution
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Local Institution
City
Prague 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Local Institution - 0067
City
Prague 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Local Institution - 0045
City
Le Chesnay Cedex
ZIP/Postal Code
78157
Country
France
Facility Name
Local Institution - 0041
City
Lille cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Local Institution
City
Pierre Bénite cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Local Institution - 0038
City
Vandoeuvre-les-Nancy Cedex
ZIP/Postal Code
54511
Country
France
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Local Institution - 0104
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Local Institution - 0106
City
Brescia
State/Province
Province Of Brescia
ZIP/Postal Code
25123
Country
Italy
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
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Local Institution - 0027
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Local Institution - 0046
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution - 0025
City
Orbassano
ZIP/Postal Code
10143
Country
Italy
Facility Name
Local Institution - 0021
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Local Institution - 0033
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Local Institution - 0039
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Local Institution - 0050
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Local Institution - 0040
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Local Institution - 0048
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Local Institution - 0047
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Local Institution - 0098
City
Katowice
ZIP/Postal Code
40-032
Country
Poland
Facility Name
Local Institution - 0064
City
Warsaw
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Local Institution - 0017
City
A Couruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution - 0018
City
L'Hospitalet Del Llobregat
ZIP/Postal Code
08908
Country
Spain
Facility Name
Local Institution - 0015
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Facility Name
Local Institution - 0012
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution - 0013
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Local Institution - 0011
City
Toledo
ZIP/Postal Code
45004
Country
Spain
Facility Name
Local Institution - 0055
City
Muang
State/Province
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Local Institution
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Local Institution - 0052
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
32265500
Citation
Cortes JE, Jiang Q, Wang J, Weng J, Zhu H, Liu X, Hochhaus A, Kim DW, Radich J, Savona M, Martin-Regueira P, Sy O, Gurnani R, Saglio G. Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study. Leukemia. 2020 Aug;34(8):2064-2073. doi: 10.1038/s41375-020-0805-1. Epub 2020 Apr 7.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
URL
http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib
We'll reach out to this number within 24 hrs