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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00331396




Registration number
NCT00331396
Ethics application status
Date submitted
21/07/2005
Date registered
25/07/2005
Date last updated
2/11/2014

Titles & IDs
Public title
Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML
Scientific 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)
Secondary ID [1] 0 0
CA180-035
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myeloid Leukemia, Chronic, Accelerated Phase 0 0
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - dasatinib
Treatment: Drugs - dasatinib

Experimental: dasatinib Twice a Day (BID) - 70 mg dasatinib twice a day (BID)

Experimental: dasatinib Once a Day (QD) - 140 mg dasatinib once a day (QD)


Treatment: Drugs: dasatinib
Tablets, Oral, 70 mg BID, indefinitely, survival study

Treatment: Drugs: dasatinib
Tablets, Oral, 140 mg QD, indefinitely, survival study
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Randomization up to 6 months
Secondary outcome [1] 0 0
Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Randomization up to 2 years
Secondary outcome [2] 0 0
Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Randomization up to 2 years
Secondary outcome [3] 0 0
Median Time to Major Hematologic Response (MaHR) - Randomized Population
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Day 1 up to 6 months (time of primary endpoint), 2 years
Secondary outcome [4] 0 0
Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Day 1 up to 5 years
Secondary outcome [5] 0 0
Percent of Participants With Overall Hematologic Response - Randomized Population
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Randomization up to 6 Months, 2 Years
Secondary outcome [6] 0 0
Number of Participants With Best Confirmed Hematologic Response, Major Hematologic Response (MaHR) and Overall Hematologic Response - Randomized Population
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Randomization up to 6 months, 2 years
Secondary outcome [7] 0 0
Percent of Participants With Major Cytogenetic Response (MCyR) - Randomized Population
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
Randomization up to 6 Months, 2 Years
Secondary outcome [8] 0 0
Number of Participants With Best Cytogenic Response (CyR) - Randomized Population
Assessment method [8] 0 0
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.
Timepoint [8] 0 0
Randomization up to 6 Months, 2 Years
Secondary outcome [9] 0 0
Median Progression Free Survival (PFS) - Randomized Population
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
Randomization up to 5 Years
Secondary outcome [10] 0 0
Median Overall Survival (OS) - Randomized Population
Assessment method [10] 0 0
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.
Timepoint [10] 0 0
Randomization up to 5 Years
Secondary outcome [11] 0 0
Progression Free Survival (PFS) and Overall Survival (OS) at 24, 36, 48, and 60 Months - Randomized Population
Assessment method [11] 0 0
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.
Timepoint [11] 0 0
24 months, 36 months, 48 months, 60 months
Secondary outcome [12] 0 0
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
Assessment method [12] 0 0
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.
Timepoint [12] 0 0
Day 1 to Year 7
Secondary outcome [13] 0 0
Number of Participants With Normal Baseline Versus Worst Grade 3/4 Hematology Laboratory Abnormalities up to Year 2 in Treated Participants
Assessment method [13] 0 0
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.
Timepoint [13] 0 0
Baseline to Year 2
Secondary outcome [14] 0 0
Number of Participants With Grade 4 Myelosuppression Determined From Hematology Evaluations
Assessment method [14] 0 0
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.
Timepoint [14] 0 0
Day 1 up to Year 7
Secondary outcome [15] 0 0
Number of Participants With Normal Baseline Versus Worst Grade 3/4 Biochemistry Laboratory Abnormalities up to Year 2 in Treated Participants
Assessment method [15] 0 0
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.
Timepoint [15] 0 0
Baseline to Year 2
Secondary outcome [16] 0 0
Number of Participants With Changes From Baseline in QT Interval Corrected With Fridericia Formula (QTcF) up to Year 2 in Treated Participants
Assessment method [16] 0 0
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).
Timepoint [16] 0 0
Baseline to Year 2
Secondary outcome [17] 0 0
Number of Participants With Maximal QTcF Intervals up to Year 2 in Treated Participants
Assessment method [17] 0 0
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.
Timepoint [17] 0 0
Baseline up to Year 2

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.



* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
Accrual to date
Final
638
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - St Leonards
Recruitment hospital [2] 0 0
Local Institution - South Brisbane
Recruitment hospital [3] 0 0
Local Institution - Adelaide
Recruitment hospital [4] 0 0
Local Institution - Parkville
Recruitment hospital [5] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
SA 5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
WA 6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
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United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
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United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
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United States of America
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Massachusetts
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Michigan
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Missouri
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Nebraska
Country [14] 0 0
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Tennessee
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United States of America
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Texas
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United States of America
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Washington
Country [23] 0 0
Argentina
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Buenos Aires
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Austria
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Wien
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Belgium
State/province [25] 0 0
B-leuven
Country [26] 0 0
Belgium
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Brugge
Country [27] 0 0
Belgium
State/province [27] 0 0
Bruxelles
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Belgium
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Charleroi
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Belgium
State/province [29] 0 0
Yvoir
Country [30] 0 0
Brazil
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Parana
Country [31] 0 0
Brazil
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Sao Paulo
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Brazil
State/province [32] 0 0
Rio De Janeiro
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Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Canada
State/province [34] 0 0
British Columbia
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Czech Republic
State/province [36] 0 0
Brno
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Czech Republic
State/province [37] 0 0
Prague 2
Country [38] 0 0
Denmark
State/province [38] 0 0
Aarhus C
Country [39] 0 0
Denmark
State/province [39] 0 0
Herlev
Country [40] 0 0
Denmark
State/province [40] 0 0
Odense C
Country [41] 0 0
Finland
State/province [41] 0 0
Helsinki
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France
State/province [42] 0 0
Caen Cedex
Country [43] 0 0
France
State/province [43] 0 0
Creteil Cedex
Country [44] 0 0
France
State/province [44] 0 0
Grenoble Cedex 9
Country [45] 0 0
France
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Lille Cedex
Country [46] 0 0
France
State/province [46] 0 0
Lyon Cedex
Country [47] 0 0
France
State/province [47] 0 0
Marseille Cedex 9
Country [48] 0 0
France
State/province [48] 0 0
Nantes
Country [49] 0 0
France
State/province [49] 0 0
Paris Cedex 10
Country [50] 0 0
France
State/province [50] 0 0
Pessac
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France
State/province [51] 0 0
Poitiers Cedex
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France
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Strasbourg Cedex
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Germany
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Dresden
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Leipzig
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Germany
State/province [57] 0 0
Mainz
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Germany
State/province [58] 0 0
Mannheim
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Greece
State/province [59] 0 0
Athens
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Hungary
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Budapest
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Ireland
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Dublin
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Israel
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Ramat-gan
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Italy
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Bari
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Italy
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Bologna
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Italy
State/province [65] 0 0
Monza
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Italy
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Napoli
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Italy
State/province [67] 0 0
Orbassano (to)
Country [68] 0 0
Italy
State/province [68] 0 0
Roma
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Korea, Republic of
State/province [69] 0 0
Jeollanam-do
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Korea, Republic of
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Seoul
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Netherlands
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Rotterdam
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Norway
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Trondheim
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Peru
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Lima
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Philippines
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Quezon City
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Poland
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Gdansk
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Warsaw
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Russian Federation
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Moscow
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Russian Federation
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St.petersburg
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Singapore
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Singapore
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South Africa
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Free State
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South Africa
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Gauteng
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South Africa
State/province [86] 0 0
Western Cape
Country [87] 0 0
Spain
State/province [87] 0 0
Barcelona
Country [88] 0 0
Spain
State/province [88] 0 0
Madrid
Country [89] 0 0
Spain
State/province [89] 0 0
Valencia
Country [90] 0 0
Sweden
State/province [90] 0 0
Lund
Country [91] 0 0
Sweden
State/province [91] 0 0
Stockholm
Country [92] 0 0
Sweden
State/province [92] 0 0
Umea
Country [93] 0 0
Sweden
State/province [93] 0 0
Uppsala
Country [94] 0 0
Switzerland
State/province [94] 0 0
Basel
Country [95] 0 0
Taiwan
State/province [95] 0 0
Taipei
Country [96] 0 0
Taiwan
State/province [96] 0 0
Taoyuan
Country [97] 0 0
Thailand
State/province [97] 0 0
Bangkok
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Greater London
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Scotland
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Tyne And Wear
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Edinburgh
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

TypeCitations or Other Details
Journal Chu SC, Tang JL, Li CC. Dasatinib in chronic myelo... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00331396