Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Conditions
Brief summary
This randomized phase II trial studies how well ruxolitinib phosphate, and bosutnib, dasatinib, imatinib or nilotinib, work in treating patients with chronic myeloid leukemia. Chronic myeloid leukemia cells produce a protein called BCR-ABL. The BCR-ABL protein helps chronic myeloid leukemia cells to grow and divide. Tyrosine kinase inhibitors, such as bosutinib, dasatinib, and nilotinib, stop the BCR-ABL protein from working, which helps to reduce the amount of chronic myeloid leukemia cells in the body. Ruxolitinib is a different type of drug that helps to stop the body from making substances called growth factors. Chronic myeloid leukemia cells need growth factors to grow and divide. The addition of ruxolitinib to the tyrosine kinase inhibitor may or may not help reduce the amount of chronic myeloid leukemia cells in the body.
Detailed description
PRIMARY OBJECTIVE: I. To compare the rate of molecular response 4.5 (MR4.5) after 12 months of combination therapy with ruxolitinib phosphate (ruxolitinib) plus a tyrosine-kinase inhibitor (TKI) (bosutinib, dasatinib, imatinib or nilotinib) versus a TKI alone, based on local polymerase chain reaction (PCR) testing to measure BCR-ABL transcripts in chronic phase chronic myelogenous leukemia (CML) patients with molecular evidence of disease. SECONDARY OBJECTIVES: I. To estimate the frequency and severity of toxicities of each regimen in this patient population. II. To estimate progression free survival and overall survival of each regimen in this patient population. ADDITIONAL OBJECTIVES: I. To describe patterns of MR4.5 and molecular response 4.0 (MR4.0) attainment and failure over the 3, 6, 9, and 12-month time points of each regimen in this patient population. II. To evaluate drug compliance based on patient reported drug intake calendars in this patient population. III. To describe the kinetics of response in this patient population (as measured by quantitative BCR-ABL/BCR ratio) in both arms over the 3, 6, 9, and 12-month time points. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive bosutinib orally (PO) daily or dasatinib PO daily or nilotinib PO twice daily (BID) or imatinib PO daily on days 1-90. Treatment repeats every 90 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive ruxolitinib phosphate PO BID on days 1-90, and bosutinib PO daily or dasatinib PO daily or nilotinib PO BID or imatinib PO daily on days 1-90. Treatment repeats every 90 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 2 years, and then annually up to 5 years.
Interventions
DRUGBosutinib
Given PO
DRUGDasatinib
Given PO
OTHERLaboratory Biomarker Analysis
Correlative studies
DRUGNilotinib
Given PO
DRUGRuxolitinib
Given PO
DRUGImatinib
Given PO
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have a diagnosis of chronic phase chronic myeloid leukemia without any history of progression to accelerated or blast phase CML; no new bone marrow aspiration and biopsy is needed to prove diagnosis prior to randomization; however, documentation stating the patient is in chronic phase is required * Patients must have detectable BCR-ABL transcripts measured by reverse transcriptase (RT)-PCR at a clinical laboratory improvement act (CLIA)-approved laboratory and reported on the international scale (IS) with a value of \> 0.0032% IS and =\< 1.0% IS within 21 days prior to randomization; the RT-PCR assay must have the sensitivity to detect a 4.5 log reduction in BCR-ABL transcripts from 100% IS (0.0032% IS or lower) * Patients must have been receiving TKI treatment for CML for at least 12 months prior to randomization. Hydroxyurea prior to initiation of TKI is allowed. * Patients must be currently receiving treatment with bosutinib (within the allowable dose range of 200-500 mg daily), nilotinib (within the allowable dose range of 150-400 mg BID or a cumulative daily dose of 300-800 mg), dasatinib (within the allowable dose range of 40-140 mg daily), or imatinib (within the allowable dose range of 300-400 mg daily); they must have received their current TKI for a minimum of 6 months prior to randomization and must be expected to remain on the same TKI for the next 12 months * Patient must not have a history of resistance to any prior TKI drug; if patient has received more than one TKI, the reason for changing treatment must have been something other than resistance or inadequate response to the prior TKI (for example, intolerance to the prior TKI) and the treatment change must have occurred \>= 6 months prior to randomization. * Patients must not be receiving any other investigational agents * Patients must have complete history and physical examination within 28 days prior to randomization * If clinically indicated, patients must have corrected Fridericia's correction formula (QTcF) interval \< 500 ms (by Fridericia calculation) on a 12-lead electrocardiography (EKG) within 7 days prior to randomization * Platelets \>= 100,000/mm\^3 (100.0 x 10\^9/L) within 7 days prior to randomization * Absolute neutrophil count (ANC) \> 1,000/mm\^3 (1.0 x 10\^9/L) within 7 days prior to randomization * Hemoglobin \>= 8 g/dL within 7 days prior to randomization * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x institutional upper limit of normal (IULN) within 7 days prior to randomization * Total bilirubin =\< 1.5 x IULN within 7 days prior to randomization (unless the patient has a known diagnosis of Gilbert's syndrome) * Serum creatinine =\< 1.5 x IULN within 7 days prior to randomization * Prior malignancy is allowed providing it does not require concurrent therapy; exception: active hormonal therapy is allowed * Patients must not be pregnant or nursing due to the teratogenic potential of the drugs used on this study; women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to randomization; women/men of reproductive potential must have agreed to use an effective contraceptive method during treatment and for 30 days after discontinuation of study drug; a woman is considered to be of reproductive potential if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, effective contraception also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures * Patients known to be human immunodeficiency virus positive (HIV+) are eligible provided they meet all other eligibility criteria and have undetectable HIV viral loads on their most recent viral load test which must have been performed in the last 6 months * Specimens (peripheral blood) must be collected and submitted to a CLIA-approved laboratory, within 21 days prior to randomization; BCR-ABL transcripts must be measured using RT-PCR and results must be reported using the international scale; the RT-PCR assay must have the sensitivity to detect a 4.5 log reduction in BCR-ABL transcripts from 100% IS (must be able to detect 0.0032% IS or lower) * Patients must be offered participation in submission of specimens for central BCR-ABL quantification and banking for future specimens; this submission is highly encouraged as an important protocol endpoint; with patient's consent, specimens must be collected and submitted, within 21 days prior to randomization * Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Molecular Response 4.5 (MR4.5) | At 12 months | The participants BCR-ABL/BCR ratio must be at least 31,623 times (4.5 logs) smaller than100% IS, i.e., must demonstrate a 4.5-log reduction relative to 100% IS. When reported on the International Scale (IS), this response is equivalent to a value of ≤ 0.0032%. Values are reported as percentages with a higher rate being better then a lower rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | From the date of randomization on study until the first of treatment failure/loss of response, progression, or death from any cause, assessed up to 5 years | Progression-free survival is measured from the date of randomization on study until the first of treatment failure/loss of response, progression, or death from any cause. Observations are censored at the date of last follow-up for patients last known to be alive without report of treatment failure/loss of response or progression. |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Duration of treatment and follow-up until death or 5 years post registration. | Only adverse events that are possibly, probably or definitely related to study drug are reported. CTCAE Version 5.0 was used for all AE reporting. |
| MR4.5 Attainment | Up to 12 months | Will be summarized descriptively |
| Overall Survival | From the date of randomization until death from any cause with observations censored at the date of last contact for patients last known to be alive, assessed up to 3 years | Overall survival will be measured for all patients from the date of randomization until death from any cause with observations censored at the date of last contact for patients last known to be alive. The results were presented as 3-year OS estimate. |
| Drug Compliance | Up to 5 years | Will be summarized descriptively, results presented as number of participants that were fully compliant for all cycles that they received treatment. |
| BCR-ABL/BCR Comparison | Up to 5 years | Quantitative RT-PCR measurement of BCR-ABL transcript levels on the International Scale (IS), expressed as log₁₀ ratios of BCR-ABL to ABL. Mean and standard deviation of log₁₀ BCR-ABL (IS) are reported at 3, 6, 9, and 12 months for each treatment arm. Lower values represent deeper molecular response. This scale ranges from 0 to -5, with a more negative number corresponding to a better outcome. |
| Molecular Rate 4.0 (MR 4.0) Attainment | Up to 12 months | Will be summarized descriptively |
Countries
United States
Participant flow
Recruitment details
81 participants were assessed for eligibility, 6 were ineligible (3 had no bone marrow at diagnosis, 2 had TKI switch due to resistance, and 1 was on TKI for less than a year). 75 participants were randomized, 38 to the Single Agent TKI arm and 37 to the TKI + Ruxolitinib arm.
Participants by arm
| Arm | Count |
|---|---|
| Single Agent TKI Patients receive bosutinib PO daily or dasatinib PO daily or nilotinib PO BID or imatinib PO daily on days 1-90. Treatment repeats every 90 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. | 38 |
| TKI + Ruxolitinib Patients receive ruxolitinib phosphate PO BID on days 1-90, and bosutinib PO daily or dasatinib PO daily or nilotinib PO BID or imatinib PO daily on days 1-90. Treatment repeats every 90 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. | 37 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 6 |
| Overall Study | Did not receive protocol therapy | 1 | 1 |
| Overall Study | Loss of response | 2 | 2 |
| Overall Study | Non-compliance | 0 | 1 |
| Overall Study | Refusal not related to toxicity | 1 | 5 |
Baseline characteristics
| Characteristic | Single Agent TKI | TKI + Ruxolitinib | Total |
|---|---|---|---|
| Age, Continuous | 55 years | 47 years | 50 years |
| ECOG PS PS 0 | 26 Participants | 25 Participants | 51 Participants |
| ECOG PS PS 1 | 12 Participants | 11 Participants | 23 Participants |
| ECOG PS PS 2 | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 29 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 7 Participants | 17 Participants |
| Length on TKI TKI: 1-4 years | 24 Participants | 21 Participants | 45 Participants |
| Length on TKI TKI: 4-10 years | 14 Participants | 16 Participants | 30 Participants |
| Molecular Response at Randomization MMR | 21 Participants | 20 Participants | 41 Participants |
| Molecular Response at Randomization MR20 | 14 Participants | 11 Participants | 25 Participants |
| Molecular Response at Randomization MR40 | 3 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Unknown | 3 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized Race White | 33 Participants | 29 Participants | 62 Participants |
| Sex: Female, Male Female | 9 Participants | 16 Participants | 25 Participants |
| Sex: Female, Male Male | 29 Participants | 21 Participants | 50 Participants |
| TKI and Randomization Bosutinib | 4 Participants | 4 Participants | 8 Participants |
| TKI and Randomization Dasatinib | 22 Participants | 24 Participants | 46 Participants |
| TKI and Randomization Imatinib | 5 Participants | 2 Participants | 7 Participants |
| TKI and Randomization Nilotinib | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 1 / 37 |
| other Total, other adverse events | 31 / 37 | 35 / 36 |
| serious Total, serious adverse events | 0 / 37 | 4 / 36 |
Outcome results
Primary
Rate of Molecular Response 4.5 (MR4.5)
The participants BCR-ABL/BCR ratio must be at least 31,623 times (4.5 logs) smaller than100% IS, i.e., must demonstrate a 4.5-log reduction relative to 100% IS. When reported on the International Scale (IS), this response is equivalent to a value of ≤ 0.0032%. Values are reported as percentages with a higher rate being better then a lower rate.
Time frame: At 12 months
Population: This population includes the 75 eligible and evaluable participants. 38 in the Single Agent TKI arm and 37 in the TKI + Ruxolitnib arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Agent TKI | Rate of Molecular Response 4.5 (MR4.5) | 3 percentage of participants |
| TKI + Ruxolitinib | Rate of Molecular Response 4.5 (MR4.5) | 14 percentage of participants |
p-value: 0.09Fisher Exact
Secondary
BCR-ABL/BCR Comparison
Quantitative RT-PCR measurement of BCR-ABL transcript levels on the International Scale (IS), expressed as log₁₀ ratios of BCR-ABL to ABL. Mean and standard deviation of log₁₀ BCR-ABL (IS) are reported at 3, 6, 9, and 12 months for each treatment arm. Lower values represent deeper molecular response. This scale ranges from 0 to -5, with a more negative number corresponding to a better outcome.
Time frame: Up to 5 years
Population: This population includes the 75 eligible and evaluable participants. 38 in the Single Agent TKI arm and 37 in the TKI + Ruxolitnib arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Agent TKI | BCR-ABL/BCR Comparison | 3-months | -1.22 Log₁₀ BCR-ABL Ratio | Standard Deviation 0.52 |
| Single Agent TKI | BCR-ABL/BCR Comparison | 6-months | -1.30 Log₁₀ BCR-ABL Ratio | Standard Deviation 0.62 |
| Single Agent TKI | BCR-ABL/BCR Comparison | 9-months | -1.32 Log₁₀ BCR-ABL Ratio | Standard Deviation 0.6 |
| Single Agent TKI | BCR-ABL/BCR Comparison | 12-months | -1.26 Log₁₀ BCR-ABL Ratio | Standard Deviation 0.55 |
| TKI + Ruxolitinib | BCR-ABL/BCR Comparison | 12-months | -1.52 Log₁₀ BCR-ABL Ratio | Standard Deviation 0.68 |
| TKI + Ruxolitinib | BCR-ABL/BCR Comparison | 3-months | -1.37 Log₁₀ BCR-ABL Ratio | Standard Deviation 0.6 |
| TKI + Ruxolitinib | BCR-ABL/BCR Comparison | 9-months | -1.47 Log₁₀ BCR-ABL Ratio | Standard Deviation 0.68 |
| TKI + Ruxolitinib | BCR-ABL/BCR Comparison | 6-months | -1.48 Log₁₀ BCR-ABL Ratio | Standard Deviation 0.64 |
Secondary
Drug Compliance
Will be summarized descriptively, results presented as number of participants that were fully compliant for all cycles that they received treatment.
Time frame: Up to 5 years
Population: This population includes the 73 participants who were eligible and received at least one dose of study treatment. 37 in the Single Agent TKI arm and 36 in the TKI + Ruxolitnib arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Agent TKI | Drug Compliance | 36 Participants |
| TKI + Ruxolitinib | Drug Compliance | 31 Participants |
Secondary
Molecular Rate 4.0 (MR 4.0) Attainment
Will be summarized descriptively
Time frame: Up to 12 months
Population: This population includes the 75 eligible and evaluable participants. 38 in the Single Agent TKI arm and 37 in the TKI + Ruxolitnib arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Agent TKI | Molecular Rate 4.0 (MR 4.0) Attainment | 3-Month Response | 16 percentage of participants |
| Single Agent TKI | Molecular Rate 4.0 (MR 4.0) Attainment | 9-Month Response | 18 percentage of participants |
| Single Agent TKI | Molecular Rate 4.0 (MR 4.0) Attainment | 6-Month Response | 13 percentage of participants |
| Single Agent TKI | Molecular Rate 4.0 (MR 4.0) Attainment | 12-Month Response | 11 percentage of participants |
| TKI + Ruxolitinib | Molecular Rate 4.0 (MR 4.0) Attainment | 6-Month Response | 24 percentage of participants |
| TKI + Ruxolitinib | Molecular Rate 4.0 (MR 4.0) Attainment | 3-Month Response | 24 percentage of participants |
| TKI + Ruxolitinib | Molecular Rate 4.0 (MR 4.0) Attainment | 12-Month Response | 19 percentage of participants |
| TKI + Ruxolitinib | Molecular Rate 4.0 (MR 4.0) Attainment | 9-Month Response | 22 percentage of participants |
Secondary
MR4.5 Attainment
Will be summarized descriptively
Time frame: Up to 12 months
Population: This population includes the 75 eligible and evaluable participants. 38 in the Single Agent TKI arm and 37 in the TKI + Ruxolitnib arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Agent TKI | MR4.5 Attainment | 3-Month Response | 3 percentage of participants |
| Single Agent TKI | MR4.5 Attainment | 6-Month Response | 3 percentage of participants |
| Single Agent TKI | MR4.5 Attainment | 9-Month Response | 0 percentage of participants |
| Single Agent TKI | MR4.5 Attainment | 12-Month Response | 3 percentage of participants |
| TKI + Ruxolitinib | MR4.5 Attainment | 12-Month Response | 14 percentage of participants |
| TKI + Ruxolitinib | MR4.5 Attainment | 3-Month Response | 8 percentage of participants |
| TKI + Ruxolitinib | MR4.5 Attainment | 9-Month Response | 14 percentage of participants |
| TKI + Ruxolitinib | MR4.5 Attainment | 6-Month Response | 5 percentage of participants |
Secondary
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Only adverse events that are possibly, probably or definitely related to study drug are reported. CTCAE Version 5.0 was used for all AE reporting.
Time frame: Duration of treatment and follow-up until death or 5 years post registration.
Population: Participants who were eligible and received at least one dose of protocol treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Agent TKI | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neutrophil count decreased | 1 Participants |
| Single Agent TKI | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Headache | 0 Participants |
| Single Agent TKI | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pancreatitis | 1 Participants |
| Single Agent TKI | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Fatigue | 0 Participants |
| Single Agent TKI | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pericardial effusion | 1 Participants |
| Single Agent TKI | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypertension | 1 Participants |
| Single Agent TKI | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Respiratory failure | 0 Participants |
| Single Agent TKI | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Nausea | 0 Participants |
| Single Agent TKI | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Vomiting | 0 Participants |
| Single Agent TKI | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Constipation | 0 Participants |
| TKI + Ruxolitinib | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Vomiting | 1 Participants |
| TKI + Ruxolitinib | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Constipation | 1 Participants |
| TKI + Ruxolitinib | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Fatigue | 1 Participants |
| TKI + Ruxolitinib | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Headache | 1 Participants |
| TKI + Ruxolitinib | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Nausea | 1 Participants |
| TKI + Ruxolitinib | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neutrophil count decreased | 2 Participants |
| TKI + Ruxolitinib | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pancreatitis | 0 Participants |
| TKI + Ruxolitinib | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pericardial effusion | 0 Participants |
| TKI + Ruxolitinib | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Respiratory failure | 1 Participants |
| TKI + Ruxolitinib | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypertension | 0 Participants |
Secondary
Overall Survival
Overall survival will be measured for all patients from the date of randomization until death from any cause with observations censored at the date of last contact for patients last known to be alive. The results were presented as 3-year OS estimate.
Time frame: From the date of randomization until death from any cause with observations censored at the date of last contact for patients last known to be alive, assessed up to 3 years
Population: This population includes the 75 eligible and evaluable participants. 38 in the Single Agent TKI arm and 37 in the TKI + Ruxolitnib arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Agent TKI | Overall Survival | 100 percentage of participants |
| TKI + Ruxolitinib | Overall Survival | 97 percentage of participants |
p-value: 0.3Log Rank
Secondary
Progression-free Survival
Progression-free survival is measured from the date of randomization on study until the first of treatment failure/loss of response, progression, or death from any cause. Observations are censored at the date of last follow-up for patients last known to be alive without report of treatment failure/loss of response or progression.
Time frame: From the date of randomization on study until the first of treatment failure/loss of response, progression, or death from any cause, assessed up to 5 years
Population: This population includes the 75 eligible and evaluable participants. 38 in the Single Agent TKI arm and 37 in the TKI + Ruxolitnib arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Agent TKI | Progression-free Survival | 89 percentage of participants |
| TKI + Ruxolitinib | Progression-free Survival | 89 percentage of participants |
p-value: 0.9Log Rank