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Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03128411
Recruitment Status : Active, not recruiting
First Posted : April 25, 2017
Results First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Phase 2, single-arm, open-label trial. Patients will receive bosutinib for the duration of the study.

Condition or disease Intervention/treatment Phase
Leukemia, Chronic Myelogenous Drug: Bosutinib Phase 2

Detailed Description:
The study will be open for enrollment until the planned number of approximately 60 Philadelphia Chromosome Positive (Ph+) patients have been registered. All patients will be treated and/or followed for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 2, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE EFFICACY AND SAFETY OF BOSUTINIB MONOTHERAPY IN JAPANESE ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : March 12, 2019
Estimated Study Completion Date : March 5, 2021


Arm Intervention/treatment
Experimental: Bosutinib
Bosutinib monotherapy; All patients will receive bosutinib at a starting dose of 400 mg QD. The dose of bosutinib may be escalated (up to a maximum of 600 mg QD) for unsatisfactory response or reduced for toxicity.
Drug: Bosutinib
All patinets will receive bosutinib at a starting dose of 400 mg QD.




Primary Outcome Measures :
  1. Percentage of Participants With Major Molecular Response (MMR) at Month 12 [ Time Frame: Month 12 ]
    A MMR is defined as less than or equal to (<=) 0.1 percent (%) BCR-ABL transcripts value on the international scale (IS) with a minimum number of 3000 ABL transcripts specified by the central laboratory. The MMR value counted only if the response was demonstrated at the 12-month visit; any MMR gained and lost, or never achieved at or before the 12-month visit was considered as non-responder.


Secondary Outcome Measures :
  1. Percentage of Participants With Major Molecular Response (MMR) by Month 12 [ Time Frame: up to Month 12 ]
    A MMR is defined as <=0.1% BCR-ABL transcripts value on the IS with a minimum number of 3000 ABL transcripts specified by the central laboratory. A participant was counted as a responder if MMR occurred at or before 12 months, respectively, even if MMR was subsequently lost at or before the 12-month visit. A participant never achieving MMR at or before 12 months was considered a non-responder, respectively.

  2. Percentage of Participants With Major Molecular Response (MMR) by Month 18 [ Time Frame: up to Month 18 ]
    A MMR is defined as <=0.1% BCR-ABL transcripts value on the IS with a minimum number of 3000 ABL transcripts specified by the central laboratory. A participant was counted as a responder if MMR occurred at or before 18 months, respectively, even if MMR was subsequently lost at or before the 18-month visit. A participant never achieving MMR at or before 18 months was considered a non-responder, respectively.

  3. Percentage of Participants With Complete Cytogenetic Response (CCyR) by Month 12 [ Time Frame: up to Month 12 ]
    CCyR is based on the prevalence of Philadelphia chromosome positive metaphases among cells in metaphase on a bone marrow sample. CCyR was defined as absence of detectable Philadelphia chromosome positive cells. CCyR achieved when there was "0" percentage of Philadelphia chromosome positive metaphases among cells in a bone marrow sample when at least 20 metaphases from a bone marrow sample were analyzed or when MMR was achieved if no bone marrow analysis was performed.

  4. Probability of Maintaining Major Molecular Response (MMR) at Week 48 [ Time Frame: From first date of MMR response to first date of confirmed loss of MMR, treatment discontinuation due to progressive disease (PD) or death due to PD within 28 days after last dose (up to data cut-off date 12 March 2019; maximum of 22 months approximately) ]
    Probability of MMR: % of participants with MMR who were still achieving MMR. MMR: time from first date of MMR response until first date of confirmed loss of MMR, treatment discontinuation due to progressive disease, or death due to disease progression within 28 days after last dose. Loss of MMR: BCR-ABL/ABL IS ratio >0.1% accompanied by at least 5-fold increase from smallest recorded BCR-ABL transcripts value confirmed by 2 assessments at least 4 weeks apart. An unconfirmed loss followed by treatment discontinuation due to suboptimal response also considered as confirmed loss. Disease progression: progression to accelerated phase or to blast phase. MMR: <= 0.1% BCR-ABL transcripts value on IS. Kaplan-Meier analysis was used.

  5. Probability of Maintaining Complete Cytogenetic Response (CCyR) at Week 48 [ Time Frame: From first date of CCyR response to first date of confirmed loss of CCyR, treatment discontinuation due to PD, or death due to PD within 28 days after last dose (up to data cut-off date, 12 March 2019; maximum of 22 months, approximately) ]
    Probability of CCyR: % of participants with CCyR who were still achieving CCyR. CCyR:from first date of response to first date of confirmed loss of response, treatment discontinuation due to progressive disease(PD)/death due to PD within 28 days after last dose. Confirmed loss: at least 1 Ph+ metaphase confirmed by a second determination >=4 weeks later or unconfirmed loss followed by treatment discontinuation due to suboptimal response.PD: progression to accelerated phase(AP) or to blast phase. CCyR based on prevalence of Ph+ cells metaphases among cells in metaphase on bone marrow sample.CCyR was 0% Ph+ cells metaphases among cells in bone marrow sample when >=20 metaphases sample analyzed or when MMR was achieved if no bone marrow analysis was performed."None" was >95% Ph+ cells. Kaplan-Meier analysis was used.

  6. Cumulative Incidence of Event Free Survival (EFS) at Week 48 [ Time Frame: From the first dose of study drug up to a maximum duration of 22 months, approximately ]
    Probability of EFS at 48 week: % of participants with EFS event at 48 weeks. EFS: time from first dose to occurrence of earliest of following events while on treatment: 1)death from any cause; 2)transformation to AP or blast phase; 3)loss of complete hematologic response (CHR); 4)loss of CCyR; 5)participants not achieving CHR: doubling of WBCs >= 1 month apart with second value >20*10^9/L and maintained in subsequent assessments for >=2 weeks. Loss of CHR: appearance of WBC count that rises to>20.0*10^9/L, platelet count that rises to >=600*10^9/L, appearance of palpable spleen/other extra medullary involvement, appearance of 5% myelocytes or blasts or promyelocytes in peripheral blood. It is further confirmed by second determination >=4 weeks later(unless associated with CML-related treatment discontinuation).Loss of CCyR:>= one Ph+ metaphase confirmed by second determination >=4 weeks later(unless associated with CML-related treatment discontinuation). Cumulative incidence was used.

  7. Probability of Overall Survival (OS) at Week 48 [ Time Frame: From the first dose of study drug to death due to any cause (maximum duration of 22 months, approximately) ]
    Overall survival is defined as the time from first dose to death due to any cause. Kaplan-Meier analysis was used for determination of probability of overall survival.

  8. Apparent Total Plasma Clearance (CL/F) of Bosutinib [ Time Frame: pre-dose on Day 1, Day 28, Day 56, Day 84 ]
  9. Apparent Volume of Distribution (Vd/F) of Bosutinib [ Time Frame: pre-dose on Day 1, Day 28, Day 56, Day 84 ]
  10. Trough Plasma Concentrations of Bosutinib [ Time Frame: pre-dose on Day 1, Day 28, Day 56, Day 84 ]
  11. Summary and Analysis of Trough Bosutinib Plasma Concentration by Major Molecular Response (MMR) Response [ Time Frame: pre-dose on Day 28, Day 56 and Day 84 ]
    Trough bosutinib plasma concentration is reported classified on basis of participants with MMR response as "Yes" and "No" at specified time points. A MMR is defined as <= 0.1 % BCR-ABL transcripts value on the IS with a minimum number of 3000 ABL transcripts specified by the central laboratory.

  12. Summary and Analysis of Trough Bosutinib Plasma Concentration by CCyR Response [ Time Frame: pre-dose on Day 28, Day 56 and Day 84 ]
    Trough bosutinib plasma concentration is reported classified on basis of participants with CCyR Response as "Yes" and "No" at specified time points. CCyR based on prevalence of Philadelphia chromosome positive cells metaphases among cells in metaphase on a bone marrow sample. CCyR achieved when there was "0" % Philadelphia chromosome positive cells metaphases among cells in bone marrow sample when at least 20 metaphases from bone marrow sample analyzed or when MMR was achieved if no bone marrow analysis was performed and "None" when there was >95% Philadelphia chromosome positive cells.

  13. Summary of Trough Bosutinib Plasma Concentration by Total Bilirubin [ Time Frame: pre-dose on Day 28, Day 56 and Day 84 ]
    Trough bosutinib plasma concentration is reported classified on basis of total bilirubin level range at specified time points. Level range 1: <=7.7 micromole per liter (micromol/L), level rage 2: >7.7 and <= 10.3 micromol/L, level range 3: >10.3 and <=12.85 micromol/L and level range 4: >12.85 micromol/L.

  14. Summary of Trough Bosutinib Plasma Concentration by Creatinine Clearance [ Time Frame: pre-dose on Day 28, Day 56 and Day 84 ]
    Trough bosutinib plasma concentration is reported classified on basis of different ranges of creatinine clearance at specified time points. Level range 1: <=71.479 milliliter per minute (mL/min), level rage 2: >71.479 and <=100.936 mL/min, level range 3: >100.936 and <=129.355 mL/min) and level range 4: >129.355 mL/min.

  15. Summary of Trough Bosutinib Plasma Concentration by Aspartate Aminotransferase [ Time Frame: pre-dose on Day 28, Day 56 and Day 84 ]
    Trough bosutinib plasma concentration is reported classified on basis of different ranges of aspartate aminotransferase at specified time points. Level range 1: <=22 units per liter (U/L), level rage 2: >22 and <=26 U/L, level range 3: >26 and <=33 U/L and level range 4: >33 U/L.

  16. Summary of Trough Bosutinib Plasma Concentration by Alanine Aminotransferase [ Time Frame: pre-dose on Day 28, Day 56 and Day 84 ]
    Trough bosutinib plasma concentration is reported classified on basis of different ranges of alanine aminotransferase at specified time points. Level range 1: <=17.5 U/L, level rage 2: >17.5 and <=25 U/L, level range 3: >25 and <=32 U/L and level range 4: >32 U/L.

  17. Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Diarrhea [ Time Frame: pre-dose on Day 28, Day 56 and Day 84 ]
    Trough bosutinib plasma concentration is reported classified on basis of presence/ or absence of grade 1 diarrhea as "Yes" and "No" at specified time points. As per national cancer institute common terminology criteria (NCI-CTCAE) version 4.03, Grade 1: increase of <4 stools per day over baseline.

  18. Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Nausea [ Time Frame: pre-dose on Day 28, Day 56 and Day 84 ]
    Trough bosutinib plasma concentration is reported classified on basis of presence/ or absence of grade 1 Nausea as "Yes" and "No" at specified time points. As per NCI-CTCAE version 4.03, Grade 1: loss of appetite without alteration in eating habits.

  19. Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Vomiting [ Time Frame: pre-dose on Day 28, Day 56 and Day 84 ]
    Trough bosutinib plasma concentration is reported classified on basis of presence/ or absence of grade 1 vomiting as "Yes" and "No" at specified time points. As per NCI-CTCAE version 4.03, Grade 1: 1 - 2 episodes (separated by 5 minutes) in 24 hours.

  20. Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Thrombocytopenia [ Time Frame: pre-dose on Day 28, Day 56 and Day 84 ]
    Trough bosutinib plasma concentration is reported classified on basis of presence/ or absence of grade 1 thrombocytopenia as "Yes" and "No" at specified time points. As per NCI-CTCAE version 4.03, Grade 1: platelet count decreased: 75.0 - 50.0*10^9/L.

  21. Number of Participants With Treatment-Emergent Adverse Events (AEs): National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3 or Higher [ Time Frame: up to data cut-off date, 12 March 2019 (up to a maximum of 22 months, approximately) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was death related to AE. Number of participants with Grade 3 or higher AEs are reported.

  22. Number of Participants With Laboratory Abnormalities, Chemistry: National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3 or 4 [ Time Frame: up to data cut-off date, 12 March 2019 (up to a maximum of 22 months, approximately) ]
    Alanine aminotransferase (ALT) increased: Grade 3: >5.0-20.0*upper limit of normal (ULN),Grade 4:>20.0*ULN, Aspartate aminotransferase (AST) increased: Grade 3: >5.0 - 20.0 *ULN, Grade 4: >20.0*ULN. Blood bilirubin increased:Grade 3:>3.0 - 10.0*ULN,Grade 4: >10.0*ULN, creatine phosphokinase (CPK) increased: Grade 3: >5*ULN-10*ULN, Grade 4: >10*ULN, Hyperglycemia: Grade 3: >250-500 milligrams/deciliter (mg/dL), Grade 4: >500 mg/dL. Hypermagnesemia: Grade 3: >3.0-8.0 mg/dL, Grade 4: >8.0 mg/dL, Hypokalemia: Grade 3: <3.0-2.5 millimoles/ liter (mmol/L), Grade 4:<2.5 mmol/L); Hyponatremia: Grade 3: <130-120 mmol/L, Grade 4: <120 mmol/L. Hypophosphatemia: Grade 3: <2.0-1.0 mg/dL, Grade 4: <1.0 mg/dL. Lipase increased: Grade 3:>2.0-5.0*ULN, Grade 4: >5.0*ULN. Serum amylase increased: Grade 3: >2.0 - 5.0*ULN, Grade 4: >5.0* ULN. Participants with CTCAE grade 3 or 4 for chemistry laboratory abnormalities reported. Only those category in which at least one participant had data were reported.

  23. Number of Participants With Laboratory Abnormalities, Hematology: National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3 or 4 [ Time Frame: up to data cut-off date, 12 March 2019 (up to a maximum of 22 months, approximately) ]
    Anemia: Grade 3: hemoglobin (Hgb) <8.0 g/dL, Grade 4: Life-threatening consequences; urgent intervention indicated, Lymphocyte count decreased: Grade 3: <500 - 200/millimeter(mm)^3, Grade 4: <200/mm^3, Neutrophil count decreased: Grade 3: <1000 - 500/mm^3, Grade 4: <500/mm^3, Platelet count decreased: Grade 3: <50.0 - 25.0*10^9 /L, Grade 4: <25.0*10^9 /L. White blood cell decreased: Grade 3: <2.0 - 1.0*10^9 /L, Grade 4: <1.0*10^9 /L. Participants with CTCAE grade 3 or 4 for Hematology laboratory abnormalities are reported. Only those category in which at least 1 participant had data were reported.

  24. Number of Participants With Laboratory Abnormalities, Coagulation: National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3 [ Time Frame: up to data cut-off date, 12 March 2019 (up to a maximum of 22 months, approximately) ]
    Activated partial thromboplastin time prolonged: Grade 3: >2.5*ULN; hemorrhage. Participants with CTCAE grade 3 for coagulation were reported.

  25. Number of Participants With Clinically Significant Vital Signs Findings [ Time Frame: up to data cut-off date, 12 March 2019 (up to a maximum of 22 months, approximately) ]
    Vital signs included: supine systolic blood pressure millimeters of mercury (mmHg): <80 mmHg and >210 mmHg, supine diastolic blood pressure (mmHg): <40 mmHg and >130 mmHg, supine heart rate beats per minute (bpm): <40 bpm and >150 bpm, temperature degree Celsius (C): <32 and >40 degree C. Clinically significance was judged by investigator.

  26. Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings [ Time Frame: up to data cut-off date, 12 March 2019 (up to a maximum of 22 months, approximately) ]
    ECG parameters included: QTc corrected by Bazett's (QTcB) interval: >500 msec, QTc corrected by Fridericia's (QTcF) interval: >500 msec and >450 msec (men) or >470 msec (women). Clinically significance was judged by investigator.

  27. Number of Participants With Interpretation Categories for Echocardiography (ECHO) or Multiple-Gated Acquisition (MUGA) [ Time Frame: at Screening and at end of treatment (up to a maximum of 22 months, approximately) ]
    ECHO and MUGA was used to assess cardiac function. A MUGA scan (also called equilibrium radionuclide angiogram or blood pool scan) is a noninvasive diagnostic test used to evaluate the pumping function of the ventricles (lower chambers of the heart). Interpretation categories for ECHO and MUGA included: a) normal, b) abnormal, not clinically significant and c) abnormal, clinically significant. Interpretation for ECHO or MUGA was judged by investigator.

  28. Percentage of Participants With Major Molecular Response (MMR) at Months 3, 6, and 9 [ Time Frame: Month 3, 6, and 9 ]
    A MMR is defined as <= 0.1 % BCR-ABL transcripts value on the IS with a minimum number of 3000 ABL transcripts specified by the central laboratory. The MMR value counted only if the response was demonstrated at the specified time points; any MMR gained and lost, or never achieved at or before the specified time points was considered as non-responder.

  29. Percentage of Participants With Molecular Response 1 (MR1) at Month 3 [ Time Frame: Month 3 ]
    MR1 is defined as <= 10% BCR-ABL with a minimum of 3,000 ABL transcripts assessed by the central laboratory.

  30. Percentage of Participants With Molecular Response 2 (MR2) at Month 6 [ Time Frame: Month 6 ]
    MR2 is defined as <= 1% BCR-ABL with a minimum of 3,000 ABL transcripts assessed by the central laboratory.

  31. Percentage of Participants With Molecular Response 4.0 (MR4.0) and Molecular Response 4.5 (MR4.5) at Months 3, 6, 9 and 12 [ Time Frame: Months 3, 6, 9 and 12 ]
    MR4.0 defined as either: detectable disease with <= 0.01% BCR-ABL with a minimum of 9,800 ABL transcripts assessed by the central laboratory, or undetectable disease in cDNA with a minimum of 9,800 ABL transcripts assessed by the central laboratory. MR4.5 defined as either: detectable disease with <= 0.0032% BCR-ABL with a minimum of 30,990 ABL transcripts assessed by the central laboratory or undetectable disease in cDNA with a minimum of 30,990 ABL transcripts assessed by the central laboratory.

  32. Cumulative Incidence of Major Molecular Response (MMR) at Week 48 [ Time Frame: up to data cut-off date, 12 March 2019 (up to a maximum of 22 months, approximately) ]
    Percentage of participants with MMR at Week 48. Cumulative incidence of MMR was measured from first dose to the first date of response. Documented participants who did not have an MMR response were censored at the last molecular assessment. A MMR is defined as <= 0.1% BCR-ABL transcripts value on the IS with a minimum number of 3000 ABL transcripts specified by the central laboratory. Cumulative incidence method was used for analysis.

  33. Cumulative Incidence of Molecular Response 4.0 (MR4.0) at Week 48 [ Time Frame: up to data cut-off date, 12 March 2019 (up to a maximum of 22 months, approximately) ]
    Percentage of participants with MR4.0 at Week 48. Cumulative incidence MR4.0, was measured from first dose to the first date of MR 4.0. MR4.0 defined as either 1) detectable disease with <=0.01% BCR-ABL IS or 2) undetectable disease in cDNA with a minimum number of 9800 ABL transcripts specified by the central laboratory. Cumulative incidence method was used for analysis.

  34. Cumulative Incidence of Molecular Response 4.5 (MR4.5) at Week 48 [ Time Frame: up to data cut-off date, 12 March 2019 (up to a maximum of 22 months, approximately) ]
    Percentage of participants with MR4.5 at Week 48. Cumulative incidence of MR 4.5, was measured from first dose to the first date of MR 4.5. MR 4.5 defined as either 1) detectable disease with <=0.0032% BCR-ABL IS or 2) undetectable disease in cDNA with a minimum number of 30990 ABL transcripts specified by the central laboratory in the same volume of cDNA used to test for BCR-ABL. Cumulative incidence method was used for analysis.

  35. Cumulative Incidence of Complete Cytogenetic Response (CCyR) at Week 48 [ Time Frame: up to data cut-off date, 12 March 2019 (up to a maximum of 22 months, approximately) ]
    Percentage of participants with CCyR at Week 48. Cumulative incidence of CCyR, was measured from first dose to the first date of CCyR. CCyR is based on the prevalence of Philadelphia chromosome positive metaphases among cells in metaphase on a bone marrow sample. CCyR was defined as absence of detectable Philadelphia chromosome positive cells. CCyR achieved when there was "0" percentage of Philadelphia chromosome positive metaphases among cells in a bone marrow sample when at least 20 metaphases from a bone marrow sample were analyzed or when MMR was achieved if no bone marrow analysis was performed. Cumulative incidence method was used for analysis.

  36. Percentage of Participants With Cumulative Complete Haematological Response (CHR) [ Time Frame: up to data cut-off date, 12 March 2019 (up to a maximum of 22 months, approximately) ]
    CHR is based on peripheral blood assessments (complete blood count including 5-part differential, platelet count, absolute neutrophil count), and clinical assessments of extra medullary disease. CHR criteria: WBC <=10*10^9/L, basophils <5% in blood, no myelocytes, promyelocytes, myeloblasts in the blood differential, platelet count <450* 10^9/L, spleen non-palpable.

  37. Cumulative Incidence of Transformation to Accelerated Phase (AP) and Blast Phase (BP) at Week 48 [ Time Frame: up to 28 days after last dose of study treatment (up to a maximum of 22 months, approximately) ]
    Percentage of participants with transformation to AP and blast phase (BP) at Week 48. Transformation to accelerated phase or to blast phase CML defined as the time from first dose to the first date of transformation to accelerated phase or to blast phase CML. The transformation to accelerated phase or to blast phase was counted while participants were on treatment up to 28 days after last dose. Participants without transformation were censored at the last hematologic assessment. Cumulative incidence method was used for analysis.

  38. Number of Participants With BCR-ABL Mutation Status at Treatment Completion [ Time Frame: up to data cut-off date, 12 March 2019 (up to a maximum of 22 months, approximately) ]
    Mutation analysis was performed in case of either lack of response, suboptimal response or loss of response, or at the End of Treatment/Withdrawal visit. Loss of response was defined as failure to achieve MMR at 12 months; loss of MMR and rise in BCR-ABL transcript level by >=5-fold from the lowest value achieved during the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of CP CML of ≤6 months (from initial diagnosis); Diagnosis of CP CML with molecular confirmation by detection of BCR-ABL rearrangement at screening (cytogenetic assessment for Ph is not required for enrollment; however, patients with known Ph- CML prior to registration are not eligible for this study)
  • Age ≥20 years
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Adequate Liver and Renal Function

Exclusion Criteria:

  • Any prior medical treatment for CML, including TKIs, with the exception of hydroxyurea treatment, which is permitted for up to 6 months prior to registration
  • Any past or current CNS involvement, including leptomeningeal leukemia
  • Extramedullary disease only
  • Major surgery or radiotherapy within 14 days prior to registration
  • History of clinically significant or uncontrolled cardiac disease
  • Patients with active, uncontrolled bacterial, fungal, or viral infection
  • Recent or ongoing clinically significant GI disorder
  • History of another malignancy within 5 years prior to registration
  • Uncontrolled hypomagnesemia or uncorrected hypokalemia due to potential effects on the QT interval
  • Known prior or suspected severe hypersensitivity to study drugs or any component in their formulations
  • Participation in other studies involving investigational drug(s) within 30 days or 5 half-lives of investigational product, whichever is longer, prior to registration and/or during study participation
  • Other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study results
  • Investigational site staff members directly involved in the conduct of the study and their family members, or Pfizer employees, including their family members, directly involved in the conduct of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128411


Locations
Show Show 21 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] March 30, 2018
Statistical Analysis Plan  [PDF] January 30, 2019

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03128411    
Other Study ID Numbers: B1871048
First Posted: April 25, 2017    Key Record Dates
Results First Posted: November 24, 2020
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Leukemia, Chronic Myelogenous
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases