Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myeloid, Chronic-Phase

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

All Drugs and Chemicals

Amino Acids

Bosutinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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.

All patients will receive bosutinib at a starting dose of 400 mg QD.

Pfizer CT.gov Call Center

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

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.

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

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

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.

A MMR is defined as less than or equal to (\<=) 0.1 percent (%) BCR-ABL transcripts on the international scale (IS), corresponding to a \>=3-log reduction from standardized baseline with at least 3000 ABL assessed 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.

A MMR is defined as less than or equal to (\<=) 0.1 percent (%) BCR-ABL transcripts on the international scale (IS), corresponding to a \>=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory. The MMR value counted only if the response was demonstrated at or before the 12-month visit.

A MMR is defined as less than or equal to (\<=) 0.1 percent (%) BCR-ABL transcripts on the international scale (IS), corresponding to a \>=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory. The MMR value counted only if the response was demonstrated at or before the 18-month visit.

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 was achieved when there were "0" Philadelphia chromosome positive metaphases among at least 20 metaphases from a bone marrow sample or when MMR was achieved if no bone marrow analysis was performed. The CCyR value was counted only if the response was demonstrated at or before the 12-month visit.

Duration of MMR: time from first date of MMR until 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 or censoring. PD: progression to Accelerated phase (AP) or to Blast Phase (BP). AP: 15-29% blasts in blood or marrow, or\>30% blasts plus promyelocytes in blood or marrow with blasts \<30%; ≥20% basophils in blood. BP: ≥30% Blasts in blood or bone marrow, extramedullary blast proliferation, other than in spleen. Kaplan-Meier analysis was used.

Duration of CCyR, from first date of CCyR to confirmed loss of CCyR, treatment discontinuation due to PD, death due to PD within 28 days after last dose or censoring. 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 AP or to BP. Kaplan-Meier analysis was used.

EFS: time from 1st dose until 1st occurrence of 1 of the following events or censoring: 1)death from any cause 2)transformation to AP or BP 3)loss of complete hematologic response (CHR) 4)loss of CCyR 5)participants not achieving CHR: doubling of WBCs \>= 1 month apart with 2nd value \>20\*10\^9/L and maintained in subsequent assessments for \>=2 weeks. Loss of CHR: appearance of any of the following confirmed by 2nd determination\>=4 weeks later (unless associated with CML-related treatment discontinuation): WBC count: \>20.0\*10\^9/L, platelet count: \>=600\*10\^9/L, appearance of palpable spleen/other extra medullary involvement, appearance of 5% myelocytes or blasts or promyelocytes in peripheral blood. Loss of CCyR:\>= one Ph+ metaphase confirmed by 2nd determination \>=4 weeks later(unless associated with CML-related treatment discontinuation). Cumulative incidence: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without event.

Overall survival was defined as the time from first dose of study drug to death due to any cause or censoring. Kaplan-Meier analysis was used for determination of probability of overall survival.

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 less than or equal to (\<=) 0.1 percent (%) BCR-ABL transcripts on the international scale (IS), corresponding to a \>=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory.

Trough bosutinib plasma concentration is reported classified on basis of participants with CCyR Response as "Yes" and "No" at specified time points. 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 was achieved when there were "0" Philadelphia chromosome positive metaphases among at least 20 metaphases from a bone marrow sample or when MMR was achieved if no bone marrow analysis was performed.

Trough bosutinib plasma concentration is reported classified on basis of total bilirubin level range at baseline. 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.

Trough bosutinib plasma concentration is reported classified on basis of different ranges of creatinine clearance at baseline. 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.

Trough bosutinib plasma concentration is reported classified on basis of different ranges of aspartate aminotransferase at baseline. 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.

Trough bosutinib plasma concentration is reported classified on basis of different ranges of alanine aminotransferase at baseline. 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.

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.

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.

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.

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.

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 indicated AE. Grade 5 was death related to AE. Number of participants with Grade 3 or higher AEs are reported.

Laboratory parameters include: Alanine aminotransferase (ALT) increased: Grade 3: \>5.0-20.0\*upper limit of normal (ULN),Grade 4:\>20.0\*ULN, Alkaline phosphatase (ALP) increased: Grade 3: \>5.0 - 20.0 x ULN, Grade 4: \>20.0 x 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.

Laboratory parameters include: 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. Only those rows in which at least 1 participant had data were reported.

Coagulation parameters include: APTT prolonged (Grade 3: \>2.5\*ULN and hemorrhage), and INR increased (Grade 3 \>2.5\*ULN).

Vital signs included: body weight Increase \>= 10% change from baseline and Decrease \>= 10% change from baseline, systolic blood pressure in millimeters of mercury (mmHg): \<80 mmHg and \>210 mmHg, diastolic blood pressure in mmHg: \<40 mmHg and \>130 mmHg, heart rate in beats per minute (bpm): \<40 bpm and \>150 bpm, temperature in degree Celsius (C): \<32 and \>40 degree C.

ECG parameters included: QTc corrected by Bazett's (QTcB) interval: \>500 msec (milliseconds), QTc corrected by Fridericia's (QTcF) interval: \>500 msec and \>450 msec (men) or \>470 msec (women).

Interpretation categories included: a) normal, b) abnormal, not clinically significant and c) abnormal, clinically significant.

A MMR is defined as less than or equal to (\<=) 0.1 percent (%) BCR-ABL transcripts on the international scale (IS), corresponding to a \>=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory. The MMR value counted only if the response was demonstrated at the designated visit; any MMR gained and lost, or never achieved at or before the designated visit was considered as non-responder.

MR1 is defined as \<= 10% BCR-ABL with a minimum of 3,000 ABL transcripts assessed by the central laboratory.

MR2 is defined as \<= 1% BCR-ABL with a minimum of 3,000 ABL transcripts assessed by the central laboratory.

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. The MMR value counted only if the response was demonstrated at the designated visit; any MMR gained and lost, or never achieved at or before the designated visit was considered as non-responder.

Percentage of participants with MMR at Month 36. 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 on the international scale, corresponding to a \>=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory. Cumulative incidence: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without the event.

Percentage of participants with MR4.0 at month 36. Cumulative incidence of MR4.0, was measured from first dose to the first date of MR 4.0. Documented participants who did not have an MR4.0 response were censored at the last molecular assessment. 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: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without the event.

Percentage of participants with MR4.5 at Month 36. Cumulative incidence of MR 4.5 was measured from first dose to the first date of MR 4.5. Documented participants who did not have an MR4.5 response were censored at the last molecular assessment. 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: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without the event.

Percentage of participants with CCyR at Month 36. Cumulative incidence of CCyR, was measured from first dose to the first date of CCyR. Documented participants who did not have a CCyR response were censored at the last cytogenetic assessment. CCyR was defined as absence of detectable Philadelphia chromosome positive cells. CCyR was achieved when there were "0" Philadelphia chromosome positive metaphases among at least 20 metaphases from a bone marrow sample or when MMR was achieved if no bone marrow analysis was performed. Cumulative incidence: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without the event.

CHR is based on peripheral blood assessment: 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. In the absence of extramedullary disease info, it was assumed that spleen was non-palpable. If CHR could not be assessed due to one or more missing components of CHR and participant had a MMR or a CCyR and all assessed components of CHR were within appropriate limits, then CHR was imputed using CCyR or MMR. CHR must be of at least 4 weeks in duration and confirmed by 2 assessments at least 4 weeks apart.

Percentage of participants with transformation to AP and BP at Month 36. Transformation to AP or to BP CML defined as the time from first dose to the first date of transformation to accelerated phase or to blast phase CML. Documented participants who did not progress to AP or BP were censored at the last hematologic assessment. The transformation to AP or to BP was counted while participants were on treatment up to 28 days after last dose. Cumulative incidence: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without the event.

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.

Pfizer

The total number of deaths occurring during study, from first dose and up to end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population evaluated.

Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

As-treated population included all enrolled participants who received at least 1 dose of study treatment.

Pfizer ClinicalTrials.gov Call Center

With a sample size of 60 participants, study was powered at \>82% to test null hypothesis: true MMR rate at 12 months (48 weeks) is 25% versus alternative hypothesis: true MMR rate is 40% with one-sided alpha of 5%.

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment.

Percentage of Participants With Major Molecular Response (MMR) at Month 12

Percentage of Participants With Major Molecular Response (MMR) by Month 12

Percentage of Participants With Major Molecular Response (MMR) by Month 18

Percentage of Participants With Complete Cytogenetic Response (CCyR) by Month 12

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and who had MMR.

Probability of Maintaining Major Molecular Response (MMR) at Month 36

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and who had CCyR.

Probability of Maintaining Complete Cytogenetic Response (CCyR) at Month 36

Cumulative Incidence of Event Free Survival (EFS) at Month 36

Probability of Overall Survival (OS) at Month 36

Day 1

Day 28

Day 56

Day 84

The PK population will be defined as any patient in the safety population of patients who had at least 1 concentration of bosutinib on-treatment.

Trough Plasma Concentrations of Bosutinib

Yes: Day 28

No: Day 28

Yes: Day 56

No: Day 56

Yes: Day 84

No: Day 84

PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of "number analyzed" against Yes and No categories respectively.

Summary and Analysis of Trough Bosutinib Plasma Concentration by Major Molecular Response (MMR) Response

Summary and Analysis of Trough Bosutinib Plasma Concentration by CCyR Response

Day 28: (<=7.7 micromol/L)

Day 28: (>7.7 and <=10.3 micromol/L)

Day 28: (>10.3 and <=12.85 micromol/L)

Day 28: (>12.85 micromol/L)

Day 56: (<=7.7 micromol/L)

Day 56: (>7.7 and <=10.3 micromol/L)

Day 56: (>10.3 and <=12.85 micromol/L)

Day 56: (>12.85 micromol/L)

Day 84: (<=7.7 micromol/L)

Day 84: (>7.7 and <=10.3 micromol/L)

Day 84: (>10.3 and <=12.85 micromol/L)

Day 84: (>12.85 micromol/L)

PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of "number analyzed" against each categories/levels respectively.

Summary of Trough Bosutinib Plasma Concentration by Total Bilirubin

Day 28: (<=71.479 mL/min)

Day 28: (>71.479 and <=10 0.936 mL/min)

Day 28: (>100.936 and <=1 29.355 mL/min)

Day 28: (>129.355 mL/min)

Day 56:(<=71.479 mL/min)

Day 56:(>71.479 and <=10 0.936 mL/min)

Day 56: (>100.936 and <=1 29.355 mL/min)

Day 56: (>129.355 mL/min)

Day 84: (<=71.479 mL/min)

Day 84:(>71.479 and <=10 0.936 mL/min)

Day 84:(>100.936 and <=1 29.355 mL/min)

Day 84: (>129.355 mL/min)

Summary of Trough Bosutinib Plasma Concentration by Creatinine Clearance

Day 28: (<=22 U/L)

Day 28: (>22 and <=26 U/L)

Day 28: (>26 and <=33 U/L)

Day 28: (>33 U/L)

Day 56: (<=22 U/L)

Day 56: (>22 and <=26 U/L)

Day 56: (>26 and <=33 U/L)

Day 56: (>33 U/L)

Day 84: (<=22 U/L)

Day 84: (>22 and <=26 U/L)

Day 84: (>26 and <=33 U/L)

Day 84: (>33 U/L)

Summary of Trough Bosutinib Plasma Concentration by Aspartate Aminotransferase

Day 28: (<=17.5 U/L)

Day 28: (>17.5 and <=25 U/L)

Day 28: (>25 and <=32 U/L)

Day 28: (>32 U/L)

Day 56: (<=17.5 U/L)

Day 56: (>17.5 and <=25 U/L)

Day 56: (>25 and <= 32 U/L)

Day 56: (>32 U/L)

Day 84: (<=17.5 U/L)

Day 84: (>17.5 and <=25 U/L)

Day 84: (>25 and <=32 U/L)

Day 84: (>32 U/L)

Summary of Trough Bosutinib Plasma Concentration by Alanine Aminotransferase

Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Diarrhea

Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Nausea

Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Vomiting

Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Thrombocytopenia

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

ALT increased

ALP increased

AST increased

Blood bilirubin increased

CPK increased

Hyperglycemia

Hypermagnesemia

Hypokalemia

Hyponatremia

Hypophosphatemia

Lipase increased

Serum amylase increased

Creatinine increased

Hypercalcemia

Hyperkalemia

Hypernatremia

Hypoalbuminemia

Hypocalcemia

Hypoglycemia

Hypomagnesemia

Number of Participants With Laboratory Abnormalities, Chemistry: National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3 or 4

Anemia

Lymphocyte count decreased

Neutrophil count decreased

Platelet count decreased

White blood cell decreased

Number of Participants With Laboratory Abnormalities, Hematology: National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3 or 4

Activated partial thromboplastin time

INR increased

Number of Participants With Laboratory Abnormalities, Coagulation: National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia	NCT03128411	Leukemia, Chron...	Bosutinib	20 Years -	Pfizer
Study of Efficacy and Safety of CML-CP Patients Treated With Asciminib Versus Best Available Therapy, Previously Treated With 2 or More Tyrosine Kinase Inhibitors	NCT04795427	Leukemia, Chron...	asciminib best available ...	18 Years -	Novartis
Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia	NCT03128411	Leukemia, Chron...	Bosutinib	20 Years -	Pfizer

Spots Global Cancer Trial Database for leukemia, chronic myelogenous