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Open-Label Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia With Stable Complete Molecular Response (DASFREE)

Primary Purpose

Chronic Phase Chronic Myeloid Leukemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dasatinib
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Phase Chronic Myeloid 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

  • Signed Written Informed Consent

  • Target Population

    1. Men and women diagnosed with CP-CML, on treatment with dasatinib for a minimum of 2 years at the time of enrollment and in dasatinib-induced complete molecular remission ongoing for at least 1 year prior to study entry.
    2. Patients are eligible if they have been in stable dasatinib induced CMR for a minimum of nine months, documented by at least three assessments, conducted 2 - 6.5 months apart, at a local lab.
    3. Subjects who have received dasatinib beyond first or second line treatment and meet other enrollment criteria are eligible for the study provided prior Tyrosine-kinase inhibitors (TKI) were discontinued due to intolerance or lack efficacy, although only one instance of lack of efficacy to TKI is allowed.
    4. Eastern Co-Operative Group (ECOG) Performance Status (PS) of 0-1

  • Age and Reproductive Status

    1. Men and women, ages ≥18
    2. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the restart of study drug
    3. Women must not be breastfeeding
    4. WOCBP must agree to follow instructions for method(s) of contraception at the restart of treatment with study drug (dasatinib) and for the duration treatment plus 30 days (duration of ovulatory cycle) for a total of 30 days post-treatment completion
    5. Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for 90 days after study entry (withdrawal of dasatinib), at restart of study drug (dasatinib) and for the duration of treatment with study drug (dasatinib) plus 90 days (duration of sperm turnover) for a total of 90 days post-treatment completion

Exclusion Criteria:

  • Target Disease Exceptions

    1. Patients who have not achieved a 1-log reduction in BCR-ABL transcript levels compared with baseline as determined by local standards or > 10% IS [International Standard]) documented at 3.0-6.5 months since the initial start of dasatinib therapy.
    2. Patients who have previously undergone hematopoietic stem cell transplantation (SCT) or who are scheduled for SCT
    3. Previous diagnosis of CML accelerated phase or blast crisis

  • Medical History and Concurrent Diseases

    1. Prior or concurrent malignancy, except the following:

      • Curatively treated basal cell or squamous cell skin cancer
      • Cervical carcinoma in situ
      • Adequately treated Stage I or II cancer from which the subject is currently in complete remission
      • Any other cancer from which the subject has been disease free for 3 years
    2. A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy in case re-initiation of dasatinib is needed.
    3. Uncontrolled or significant cardiovascular disease
    4. Subjects with prior history of pericardial effusion or pleural effusion that required thoracentesis are excluded. Subjects with prior history of pericardial or pleural effusion that was clinically manageable and a maintained CMR for ≥ 1 year on a stable dose of dasatinib are allowed.
    5. History of significant bleeding disorder unrelated to CML

  • Allergies and Adverse Drug Reaction

    a. Subjects with known hypersensitivity to excipients of Dasatinib tablets

  • Sex and Reproductive Status

    1. Patients who are pregnant or breastfeeding or likely to become pregnant
    2. Men whose partner is unwilling or unable to avoid pregnancy

  • Other Exclusion Criteria

    1. Patients with a history of non-compliance to CML treatment and monitoring requirements
    2. Prisoners or subjects who are involuntarily incarcerated

  • Additional Criteria for Patients Eligible to Restart Dasatinib

    • Any patient who has lost MMR and is eligible for re-starting dasatinib therapy must not have developed a condition that precludes dasatinib use.

Other protocol defined inclusion/exclusion criteria could apply

Sites / Locations

  • Local Institution - 0006
  • Local Institution - 0029
  • Local Institution - 0001
  • Local Institution - 0013
  • Local Institution - 0024
  • Local Institution - 0028
  • Local Institution - 0011
  • Local Institution - 0023
  • Local Institution - 0005
  • Local Institution - 0012
  • Local Institution - 0003
  • Local Institution - 0030
  • Local Institution - 0002
  • Local Institution - 0019
  • Local Institution - 0026
  • Local Institution - 0020
  • Local Institution - 0021
  • Local Institution - 0022
  • Local Institution - 0025
  • Local Institution - 0017
  • Local Institution - 0027
  • Local Institution - 0015
  • Local Institution - 0018
  • Local Institution - 0016
  • Local Institution - 0014
  • Local Institution - 0009
  • Local Institution - 0010
  • Local Institution - 0008

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dasatinib

Arm Description

Dasatinib 50, 80, 100, 140, 180 mg tablets by mouth, once daily, up to 60 months

Outcomes

Primary Outcome Measures

Major Molecular Response (MMR) Rate
Major Molecular Response (MMR) rate at 12 months is the percentage of participants who maintain MMR (BCR-ABL transcripts < 0.1% on the International Scale [IS]) at 12 months after Dasatinib discontinuation without restarting Dasatinib

Secondary Outcome Measures

Event-Free Survival (EFS) Rate
Event-free survival (EFS) rate is defined as the percentage of surviving participants with no loss of Major Molecular Response (MMR) at the specified timepoints after dasatinib discontinuation. MMR is defined as BCR-ABL transcripts < 0.1% IS. Loss of MMR is defined per the European LeukemiaNet (ELN) definition of progression. Progression is defined as Transformation to Accelerated Phase or Blast Crisis (AP/BC): Accelerated Phase (AP) Blasts in PB or BM 15-29%; Blast + promyelocytes ≥ 30% with blasts < 30% or ACA in Ph+ cells (clonal progression), or basophils in blood ≥ 20%,or platelets < 100 x 10^9 /L unrelated to therapy Blastic Phase or Crisis (BP/BC) Blasts in PB or BM ≥ 30%, or extramedullary blast cell involvement (with exception of spleen and liver) The date of progression is defined as the date any of the above criteria is first met. Participants who have not progressed will be censored on the date of last examination.
Relapse-Free Survival (RFS) Rate
RFS is the percentage of participants who did not relapse at the specified timepoints. Participants who did not relapse were censored on the date of their last molecular assessment. Relapse is defined as any of the following events while on study: the loss of Major Molecular Response (MMR), loss of Complete Cytogenetic Response (CCyR), loss of Complete Hematologic Response (CHR) or progression to advanced/blastic phase. MMR is defined as BCR-ABL transcripts < 0.1% IS. Cytogenetic response (CyR) is based on the prevalence of Ph+ cells in metaphase from bone marrow (BM) sample based on evaluation of at least 20 metaphases. CCyR is defined as 0% Ph+ cells in metaphase in BM. CHR is obtained when all the following criteria are met in peripheral blood (PB) sampling: white blood cell ≤10,000/mm3; Platelets < 450,000/mm3; PB basophils <5%; No blasts or promyelocytes in PB; <5% myelocytes plus metamyelocytes in PB; No extramedullary involvement (including no hepatomegaly or splenomegaly).
Progression Free Survival (PFS) Rate
Progression free survival (PFS) is defined as the percentage of participants who experienced death (due to any cause) or accelerated phase, or blast crisis. Participants who neither progress nor die will be censored on the date of their last molecular assessment. Progression is defined as Transformation to Accelerated Phase or Blast Crisis (AP/BC) Accelerated Phase (AP) Blasts in PB or BM 15-29%; Blast + promyelocytes >= 30% with blasts < 30% or ACA in Ph+ cells (clonal progression), or basophils in blood >= 20%,or platelets < 100 x 109 /L unrelated to therapy Blastic Phase or Crisis (BP/BC) Blasts in PB or BM >= 30%, or extramedullary blast cell involvement (with the exception of spleen and liver)
Number of Participants Who Experience Intermittent Loss of Complete Molecular Response (CMR) (MR4.5) But no Loss of Major Molecular Response (MMR)
The number of participants who did not lose major molecular response (MMR) 60 months after discontinuing study treatment who were in MR4.5 at the time of discontinuation and lost MR4.5. Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (Q-PCR). MMR is defined as BCR-ABL transcripts < 0.1% Internal Standard (IS). CMR (MR4.5) defined as ≤ 0.0032% (IS) or ≥ 4.5 log reduction of BCR-ABL transcript levels molecular response.
Number of Participants Who Did Not Experience Loss of Complete Molecular Response (CMR) (MR4.5) and Major Molecular Response (MMR)
Assessment of BCR-ABL kinetics in patients who are in CMR (MR4.5) or less when transcript levels are still measurable. CMR (MR4.5) defined as ≤ 0.0032% (IS) or ≥ 4.5 log reduction of BCR-ABL transcript levels molecular response.
Time to Transformation to Accelerated Phase/Blast Crisis (AP/BC)
Time to Transformation to AP/BC is defined as the rate at which participants experienced transformation to accelerated phase/blast crisis (AP/BC) since discontinuation. Participants who did not develop to AP, late phase, or BC phase were censored on their last molecular measurement date.
Overall Survival (OS)
Overall survival (OS) is defined as the time from dasatinib treatment discontinuation to the date of death (due to any cause) or last known alive date. Participants who do not die will be censored on their last known alive date.
Progression Free Survival
Progression-free survival (PFS) is defined as the time from treatment discontinuation to the date of progression or death (due to any cause), whichever occurs first. Participants who neither progress nor die will be censored on the date of their last molecular assessment.

Full Information

First Posted
May 8, 2013
Last Updated
October 5, 2022
Sponsor
Bristol-Myers Squibb
Collaborators
ICON plc, PPD, Molecular MD, European Organisation for Research and Treatment of Cancer - EORTC, MultiPharma, Steering Committee
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1. Study Identification

Unique Protocol Identification Number
NCT01850004
Brief Title
Open-Label Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia With Stable Complete Molecular Response
Acronym
DASFREE
Official Title
Open-Label Single Arm Phase 2 Study Evaluating Dasatinib Therapy Discontinuation In Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) With Stable Complete Molecular Response (CMR) DASFREE
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 22, 2014 (Actual)
Primary Completion Date
September 20, 2017 (Actual)
Study Completion Date
October 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
ICON plc, PPD, Molecular MD, European Organisation for Research and Treatment of Cancer - EORTC, MultiPharma, Steering Committee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study purpose is to test the hypothesis that Chronic Phase Chronic Myeloid Leukemia (CP-CML) patients with stable Complete Molecular Response (CMR) who discontinue Dasatinib treatment are able to maintain a sustained remission in the long-term, with undetectable or minimally detectable BCR-ABL residual disease.
Detailed Description
Primary Purpose: Protocol designed to evaluate remission of disease after treatment discontinuation. Treatment re-started if relapse occurs

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
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dasatinib
Arm Type
Experimental
Arm Description
Dasatinib 50, 80, 100, 140, 180 mg tablets by mouth, once daily, up to 60 months
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
Sprycel
Primary Outcome Measure Information:
Title
Major Molecular Response (MMR) Rate
Description
Major Molecular Response (MMR) rate at 12 months is the percentage of participants who maintain MMR (BCR-ABL transcripts < 0.1% on the International Scale [IS]) at 12 months after Dasatinib discontinuation without restarting Dasatinib
Time Frame
At 12 months after Dasatinib discontinuation (assessed up to approximately June 4, 2018)
Secondary Outcome Measure Information:
Title
Event-Free Survival (EFS) Rate
Description
Event-free survival (EFS) rate is defined as the percentage of surviving participants with no loss of Major Molecular Response (MMR) at the specified timepoints after dasatinib discontinuation. MMR is defined as BCR-ABL transcripts < 0.1% IS. Loss of MMR is defined per the European LeukemiaNet (ELN) definition of progression. Progression is defined as Transformation to Accelerated Phase or Blast Crisis (AP/BC): Accelerated Phase (AP) Blasts in PB or BM 15-29%; Blast + promyelocytes ≥ 30% with blasts < 30% or ACA in Ph+ cells (clonal progression), or basophils in blood ≥ 20%,or platelets < 100 x 10^9 /L unrelated to therapy Blastic Phase or Crisis (BP/BC) Blasts in PB or BM ≥ 30%, or extramedullary blast cell involvement (with exception of spleen and liver) The date of progression is defined as the date any of the above criteria is first met. Participants who have not progressed will be censored on the date of last examination.
Time Frame
From 12 months after Dasatinib treatment discontinuation to every 12 months thereafter (up to approximately 60 months)
Title
Relapse-Free Survival (RFS) Rate
Description
RFS is the percentage of participants who did not relapse at the specified timepoints. Participants who did not relapse were censored on the date of their last molecular assessment. Relapse is defined as any of the following events while on study: the loss of Major Molecular Response (MMR), loss of Complete Cytogenetic Response (CCyR), loss of Complete Hematologic Response (CHR) or progression to advanced/blastic phase. MMR is defined as BCR-ABL transcripts < 0.1% IS. Cytogenetic response (CyR) is based on the prevalence of Ph+ cells in metaphase from bone marrow (BM) sample based on evaluation of at least 20 metaphases. CCyR is defined as 0% Ph+ cells in metaphase in BM. CHR is obtained when all the following criteria are met in peripheral blood (PB) sampling: white blood cell ≤10,000/mm3; Platelets < 450,000/mm3; PB basophils <5%; No blasts or promyelocytes in PB; <5% myelocytes plus metamyelocytes in PB; No extramedullary involvement (including no hepatomegaly or splenomegaly).
Time Frame
From 12 months after Dasatinib treatment discontinuation to every 6 months thereafter (up to approximately 60 months)
Title
Progression Free Survival (PFS) Rate
Description
Progression free survival (PFS) is defined as the percentage of participants who experienced death (due to any cause) or accelerated phase, or blast crisis. Participants who neither progress nor die will be censored on the date of their last molecular assessment. Progression is defined as Transformation to Accelerated Phase or Blast Crisis (AP/BC) Accelerated Phase (AP) Blasts in PB or BM 15-29%; Blast + promyelocytes >= 30% with blasts < 30% or ACA in Ph+ cells (clonal progression), or basophils in blood >= 20%,or platelets < 100 x 109 /L unrelated to therapy Blastic Phase or Crisis (BP/BC) Blasts in PB or BM >= 30%, or extramedullary blast cell involvement (with the exception of spleen and liver)
Time Frame
From 12 months after Dasatinib treatment discontinuation to every 6 months thereafter (up to approximately 60 months)
Title
Number of Participants Who Experience Intermittent Loss of Complete Molecular Response (CMR) (MR4.5) But no Loss of Major Molecular Response (MMR)
Description
The number of participants who did not lose major molecular response (MMR) 60 months after discontinuing study treatment who were in MR4.5 at the time of discontinuation and lost MR4.5. Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (Q-PCR). MMR is defined as BCR-ABL transcripts < 0.1% Internal Standard (IS). CMR (MR4.5) defined as ≤ 0.0032% (IS) or ≥ 4.5 log reduction of BCR-ABL transcript levels molecular response.
Time Frame
60 months after last dose
Title
Number of Participants Who Did Not Experience Loss of Complete Molecular Response (CMR) (MR4.5) and Major Molecular Response (MMR)
Description
Assessment of BCR-ABL kinetics in patients who are in CMR (MR4.5) or less when transcript levels are still measurable. CMR (MR4.5) defined as ≤ 0.0032% (IS) or ≥ 4.5 log reduction of BCR-ABL transcript levels molecular response.
Time Frame
From 12 months after Dasatinib treatment discontinuation to 5 years after the first visit of the last enrolled participant (up to approximately 82 months)
Title
Time to Transformation to Accelerated Phase/Blast Crisis (AP/BC)
Description
Time to Transformation to AP/BC is defined as the rate at which participants experienced transformation to accelerated phase/blast crisis (AP/BC) since discontinuation. Participants who did not develop to AP, late phase, or BC phase were censored on their last molecular measurement date.
Time Frame
From 12 months after Dasatinib treatment discontinuation to 5 years after the first visit of the last enrolled participant (up to approximately 82 months)
Title
Overall Survival (OS)
Description
Overall survival (OS) is defined as the time from dasatinib treatment discontinuation to the date of death (due to any cause) or last known alive date. Participants who do not die will be censored on their last known alive date.
Time Frame
From 12 months after Dasatinib treatment discontinuation to the date of death or last known alive date (up to approximately 82 months)
Title
Progression Free Survival
Description
Progression-free survival (PFS) is defined as the time from treatment discontinuation to the date of progression or death (due to any cause), whichever occurs first. Participants who neither progress nor die will be censored on the date of their last molecular assessment.
Time Frame
From treatment discontinuation to the date of progression or death due to any cause, whichever occurs first (up to 82 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria Signed Written Informed Consent Target Population Men and women diagnosed with CP-CML, on treatment with dasatinib for a minimum of 2 years at the time of enrollment and in dasatinib-induced complete molecular remission ongoing for at least 1 year prior to study entry. Patients are eligible if they have been in stable dasatinib induced CMR for a minimum of nine months, documented by at least three assessments, conducted 2 - 6.5 months apart, at a local lab. Subjects who have received dasatinib beyond first or second line treatment and meet other enrollment criteria are eligible for the study provided prior Tyrosine-kinase inhibitors (TKI) were discontinued due to intolerance or lack efficacy, although only one instance of lack of efficacy to TKI is allowed. Eastern Co-Operative Group (ECOG) Performance Status (PS) of 0-1 Age and Reproductive Status Men and women, ages ≥18 Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the restart of study drug Women must not be breastfeeding WOCBP must agree to follow instructions for method(s) of contraception at the restart of treatment with study drug (dasatinib) and for the duration treatment plus 30 days (duration of ovulatory cycle) for a total of 30 days post-treatment completion Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for 90 days after study entry (withdrawal of dasatinib), at restart of study drug (dasatinib) and for the duration of treatment with study drug (dasatinib) plus 90 days (duration of sperm turnover) for a total of 90 days post-treatment completion Exclusion Criteria: Target Disease Exceptions Patients who have not achieved a 1-log reduction in BCR-ABL transcript levels compared with baseline as determined by local standards or > 10% IS [International Standard]) documented at 3.0-6.5 months since the initial start of dasatinib therapy. Patients who have previously undergone hematopoietic stem cell transplantation (SCT) or who are scheduled for SCT Previous diagnosis of CML accelerated phase or blast crisis Medical History and Concurrent Diseases Prior or concurrent malignancy, except the following: Curatively treated basal cell or squamous cell skin cancer Cervical carcinoma in situ Adequately treated Stage I or II cancer from which the subject is currently in complete remission Any other cancer from which the subject has been disease free for 3 years A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy in case re-initiation of dasatinib is needed. Uncontrolled or significant cardiovascular disease Subjects with prior history of pericardial effusion or pleural effusion that required thoracentesis are excluded. Subjects with prior history of pericardial or pleural effusion that was clinically manageable and a maintained CMR for ≥ 1 year on a stable dose of dasatinib are allowed. History of significant bleeding disorder unrelated to CML Allergies and Adverse Drug Reaction a. Subjects with known hypersensitivity to excipients of Dasatinib tablets Sex and Reproductive Status Patients who are pregnant or breastfeeding or likely to become pregnant Men whose partner is unwilling or unable to avoid pregnancy Other Exclusion Criteria Patients with a history of non-compliance to CML treatment and monitoring requirements Prisoners or subjects who are involuntarily incarcerated Additional Criteria for Patients Eligible to Restart Dasatinib Any patient who has lost MMR and is eligible for re-starting dasatinib therapy must not have developed a condition that precludes dasatinib use. Other protocol defined inclusion/exclusion criteria could apply
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 - 0006
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Local Institution - 0029
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Local Institution - 0001
City
San Franisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Local Institution - 0013
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Local Institution - 0024
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Local Institution - 0028
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Local Institution - 0011
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Local Institution - 0023
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4000
Country
United States
Facility Name
Local Institution - 0005
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution - 0012
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Local Institution - 0003
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Local Institution - 0030
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Local Institution - 0002
City
Vandoeuvre-les-Nancy CEDEX
ZIP/Postal Code
54511
Country
France
Facility Name
Local Institution - 0019
City
Rostock
State/Province
Mecklenburg Vorpommern
ZIP/Postal Code
18057
Country
Germany
Facility Name
Local Institution - 0026
City
Aachen
ZIP/Postal Code
D-52074
Country
Germany
Facility Name
Local Institution - 0020
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Local Institution - 0021
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Local Institution - 0022
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Local Institution - 0025
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Local Institution - 0017
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Local Institution - 0027
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution - 0015
City
Orbassano
ZIP/Postal Code
10143
Country
Italy
Facility Name
Local Institution - 0018
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Local Institution - 0016
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Local Institution - 0014
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Local Institution - 0009
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Facility Name
Local Institution - 0010
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Local Institution - 0008
City
Malaga
ZIP/Postal Code
29010
Country
Spain

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

Open-Label Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia With Stable Complete Molecular Response

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