Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation
NCT ID: NCT04666259
Last Updated: 2025-10-16
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
56 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-05-25
Study Completion Date
2024-06-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study was a multicenter Phase IIIb open-label, three-cohort study of asciminib in patients with CML-CP without T315I mutation who have had at least 2 prior TKIs and CML-CP harboring the T315I mutation with at least 1 prior TKI
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib.
NCT06514534
Chronic Myeloid Leukemia (CML)
RECRUITING
PHASE2
Asciminib Treatment Optimization in ≥ 3rd Line CML-CP
NCT04948333
Chronic Myelogenous Leukemia
ACTIVE_NOT_RECRUITING
PHASE3
A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL
NCT02081378
Chronic Myelogenous Leukemia
Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
COMPLETED
PHASE1
A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)
NCT05456191
Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
ACTIVE_NOT_RECRUITING
PHASE3
Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia
NCT05384587
Chronic Myelogenous Leukemia - Chronic Phase
ACTIVE_NOT_RECRUITING
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This trial consisted of three periods: screening and baseline for up to 21 days, active treatment for up to 72 weeks and a safety follow up period for 30 days.
One hundred and fifteen (115) patients with chronic myeloid leukemia in chronic phase (CML-CP) without T315I mutation who have had at least 2 prior Tyrosine Kinase Inhibitors (TKIs) and CML-CP with the T315I mutation with at least 1 prior TKI were planned for this study, however the study was finally completed with 56 participants due to enrollment issues.
Informed consent was obtained before any procedures were performed for the study including eligibility assessments. The results of the real time quantitative polymerase chain reaction (RQ-PCR) must be available prior to randomization and first dose of study treatment.
Patients with CML-CP without T315I mutation were randomly assigned to either cohort A or B. Patients with the T315I mutation were enrolled in cohort C. During treatment period asciminib was taken orally: Cohort A was administered 40 mg twice a day, Cohort B was administered 80 mg once a day and Cohort C was administered 200 mg twice a day. The patients were treated up to end of study treatment period defined as up to 72 weeks after the last patient receives the first dose. Patients may have been discontinued from treatment with the study drug at any time due to unacceptable toxicity, disease progression and/or at the discretion of the investigator or the patient.
One hundred and fifteen (115) patients with chronic myeloid leukemia in chronic phase (CML-CP) without T315I mutation who have had at least 2 prior Tyrosine Kinase Inhibitors (TKIs) and CML-CP with the T315I mutation with at least 1 prior TKI were planned for this study, however the study was finally completed with 56 participants due to enrollment issues.
Informed consent was obtained before any procedures were performed for the study including eligibility assessments. The results of the real time quantitative polymerase chain reaction (RQ-PCR) must be available prior to randomization and first dose of study treatment.
Patients with CML-CP without T315I mutation were randomly assigned to either cohort A or B. Patients with the T315I mutation were enrolled in cohort C. During treatment period asciminib was taken orally: Cohort A was administered 40 mg twice a day, Cohort B was administered 80 mg once a day and Cohort C was administered 200 mg twice a day. The patients were treated up to end of study treatment period defined as up to 72 weeks after the last patient receives the first dose. Patients may have been discontinued from treatment with the study drug at any time due to unacceptable toxicity, disease progression and/or at the discretion of the investigator or the patient.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Chronic Myelogenous Leukemia - Chronic Phase
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Cohort A and B will be randomized but not C
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A
40 mg asciminib orally twice daily (BID)
Group Type
EXPERIMENTAL
ABL001
Intervention Type
DRUG
Asciminib will be supplied as 20 mg or 40 mg strength tablets will be administered orally in accordance with the assigned cohort.
Cohort B
80 mg asciminib orally once daily (QD)
Group Type
EXPERIMENTAL
ABL001
Intervention Type
DRUG
Asciminib will be supplied as 20 mg or 40 mg strength tablets will be administered orally in accordance with the assigned cohort.
Cohort C
200 mg asciminib orally twice daily (BID)
Group Type
EXPERIMENTAL
ABL001
Intervention Type
DRUG
Asciminib will be supplied as 20 mg or 40 mg strength tablets will be administered orally in accordance with the assigned cohort.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ABL001
Asciminib will be supplied as 20 mg or 40 mg strength tablets will be administered orally in accordance with the assigned cohort.
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Participants eligible for inclusion in this study must meet all of the following criteria:
1. Written informed consent must be obtained and signed prior to participation in the study
2. Male or female patients with a diagnosis of CML-CP ≥ 18 years of age
3. Patients must meet all of the following laboratory values at the screening visit:
* \< 15% blasts in peripheral blood and/or bone marrow
* \< 30% blasts plus promyelocytes in peripheral blood and/or bone marrow
* \< 20% basophils in the peripheral blood
* ≥ 50 x 109/L (≥ 50,000/ mm3) platelets
* Transient prior therapy related thrombocytopenia (\< 50,000/mm3 for ≤ 30 days prior to screening) is acceptable
* No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly
4. Mutation Analysis testing performed 6 months before study entry
5. Prior treatment with a minimum of:
* 2 prior ATP-site TKIs (i.e. imatinib, nilotinib, bosutinib, dasatinib or ponatinib) in case of absence of T315I mutation
* 1 prior ATP site TKI (i.e. imatinib, nilotinib, bosutinib, dasatinib or ponatinib) in case of presence of T315I mutation
6. Failure (adapted from the 2020 ELN Recommendations) or intolerance to the most recent TKI therapy at the time of screening
* Failure for CML-CP patients (CP at the time of initiation of last therapy) is defined as meeting at least one of the following criteria.
* Three months after the initiation of therapy: \>10% BCR-ABL1 on International Scale (IS) if confirmed within 1-3 months
* Six months after the initiation of therapy: BCR-ABL1 ratio \> 10% IS
* Twelve months after initiation of therapy: BCR-ABL1 ratio \> 1% IS
* At any time after the initiation of therapy, loss of CHR, MR2
* At any time after the initiation of therapy, the development of new BCR-ABL1 mutations which potentially cause resistance to current treatment
* At any time 12 months after the initiation of therapy, BCR-ABL1 ratio ≥ 1% IS or loss of MMR
* At any time after the initiation of therapy, new clonal chromosome abnormalities in Ph+ cells: CCA/Ph+
* Intolerance is defined as:
* Non-hematologic intolerance: Patients with grade 3 or 4 toxicity while on therapy, or with persistent grade 2 toxicity, unresponsive to optimal management, including dose adjustments (unless dose reduction is not considered in the best interest of the patient if response is already suboptimal)
* Hematologic intolerance: Patients with grade 3 or 4 toxicity (absolute neutrophil count \[ANC\] or platelets) while on therapy that is recurrent after dose reduction to the lowest doses recommended by manufacturer
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
8. Evidence of typical BCR-ABL1 transcript \[e14a2 and/or e13a2\] at the time of screening which are amenable to standardized RQ-PCR quantification.
9. Adequate end organ function, within 12 days before the first dose of asciminib treatment. Patients with mild to moderate renal and hepatic impairment are eligible if:
* Total bilirubin ≤ 3.0 x ULN without AST/ALT increase
* Aspartate transaminase (AST) ≤ 5.0 x ULN
* Alanine transaminase (ALT) ≤ 5.0 x ULN
* Serum lipase ≤ 1.5 x ULN. For serum lipase \> ULN - ≤ 1.5 x ULN, value should be considered not clinically significant and not associated with risk factors for acute pancreatitis
* Alkaline phosphatase ≤ 2.5 x ULN
* Creatinine clearance ≥ 30 mL/min as calculated using Cockcroft-Gault formula
10. Patients must avoid consumption of grapefruit, Seville oranges or products containing the juice of each during the entire study and preferably 7 days before the first dose of study medications, due to potential CYP3A4 interaction with the study medications. Orange juice is allowed.
11. Treatment with medications that meet one of the following criteria is allowed if used with caution at least one week prior to the start of treatment with study treatment:
* Moderate or strong inducers of CYP3A
* Moderate or strong inhibitors of CYP3A
12. Patients must have the following electrolyte values (as per central laboratory tests) within normal limits or corrected to be within normal limits with supplements prior to first dose of study medication:
* Potassium (potassium increase of up to 6.0 mmol/L is acceptable at study entry if associated with creatinine clearance within normal limits)
* Total calcium (corrected for serum albumin); (calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable at study entry if associated with creatinine clearance within normal limits)
* Magnesium, with the exception of magnesium increase \> ULN - 3.0 mg/dL; \> ULN - 1.23 mmol/L associated with creatinine clearance (calculated using Cockcroft-Gault formula) within normal limits.
1. Written informed consent must be obtained and signed prior to participation in the study
2. Male or female patients with a diagnosis of CML-CP ≥ 18 years of age
3. Patients must meet all of the following laboratory values at the screening visit:
* \< 15% blasts in peripheral blood and/or bone marrow
* \< 30% blasts plus promyelocytes in peripheral blood and/or bone marrow
* \< 20% basophils in the peripheral blood
* ≥ 50 x 109/L (≥ 50,000/ mm3) platelets
* Transient prior therapy related thrombocytopenia (\< 50,000/mm3 for ≤ 30 days prior to screening) is acceptable
* No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly
4. Mutation Analysis testing performed 6 months before study entry
5. Prior treatment with a minimum of:
* 2 prior ATP-site TKIs (i.e. imatinib, nilotinib, bosutinib, dasatinib or ponatinib) in case of absence of T315I mutation
* 1 prior ATP site TKI (i.e. imatinib, nilotinib, bosutinib, dasatinib or ponatinib) in case of presence of T315I mutation
6. Failure (adapted from the 2020 ELN Recommendations) or intolerance to the most recent TKI therapy at the time of screening
* Failure for CML-CP patients (CP at the time of initiation of last therapy) is defined as meeting at least one of the following criteria.
* Three months after the initiation of therapy: \>10% BCR-ABL1 on International Scale (IS) if confirmed within 1-3 months
* Six months after the initiation of therapy: BCR-ABL1 ratio \> 10% IS
* Twelve months after initiation of therapy: BCR-ABL1 ratio \> 1% IS
* At any time after the initiation of therapy, loss of CHR, MR2
* At any time after the initiation of therapy, the development of new BCR-ABL1 mutations which potentially cause resistance to current treatment
* At any time 12 months after the initiation of therapy, BCR-ABL1 ratio ≥ 1% IS or loss of MMR
* At any time after the initiation of therapy, new clonal chromosome abnormalities in Ph+ cells: CCA/Ph+
* Intolerance is defined as:
* Non-hematologic intolerance: Patients with grade 3 or 4 toxicity while on therapy, or with persistent grade 2 toxicity, unresponsive to optimal management, including dose adjustments (unless dose reduction is not considered in the best interest of the patient if response is already suboptimal)
* Hematologic intolerance: Patients with grade 3 or 4 toxicity (absolute neutrophil count \[ANC\] or platelets) while on therapy that is recurrent after dose reduction to the lowest doses recommended by manufacturer
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
8. Evidence of typical BCR-ABL1 transcript \[e14a2 and/or e13a2\] at the time of screening which are amenable to standardized RQ-PCR quantification.
9. Adequate end organ function, within 12 days before the first dose of asciminib treatment. Patients with mild to moderate renal and hepatic impairment are eligible if:
* Total bilirubin ≤ 3.0 x ULN without AST/ALT increase
* Aspartate transaminase (AST) ≤ 5.0 x ULN
* Alanine transaminase (ALT) ≤ 5.0 x ULN
* Serum lipase ≤ 1.5 x ULN. For serum lipase \> ULN - ≤ 1.5 x ULN, value should be considered not clinically significant and not associated with risk factors for acute pancreatitis
* Alkaline phosphatase ≤ 2.5 x ULN
* Creatinine clearance ≥ 30 mL/min as calculated using Cockcroft-Gault formula
10. Patients must avoid consumption of grapefruit, Seville oranges or products containing the juice of each during the entire study and preferably 7 days before the first dose of study medications, due to potential CYP3A4 interaction with the study medications. Orange juice is allowed.
11. Treatment with medications that meet one of the following criteria is allowed if used with caution at least one week prior to the start of treatment with study treatment:
* Moderate or strong inducers of CYP3A
* Moderate or strong inhibitors of CYP3A
12. Patients must have the following electrolyte values (as per central laboratory tests) within normal limits or corrected to be within normal limits with supplements prior to first dose of study medication:
* Potassium (potassium increase of up to 6.0 mmol/L is acceptable at study entry if associated with creatinine clearance within normal limits)
* Total calcium (corrected for serum albumin); (calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable at study entry if associated with creatinine clearance within normal limits)
* Magnesium, with the exception of magnesium increase \> ULN - 3.0 mg/dL; \> ULN - 1.23 mmol/L associated with creatinine clearance (calculated using Cockcroft-Gault formula) within normal limits.
Exclusion Criteria
Patients eligible for this study must not meet any of the following criteria:
1. Known second chronic phase of CML after previous progression to AP/BC
2. Previous treatment with a hematopoietic stem-cell transplantation
3. Cardiac or cardiac repolarization abnormality, including any of the following:
* History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG)
* Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block)
* QTcF at screening ≥450 msec (male patients), ≥460 msec (female patients)
* Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
* Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
* Concomitant medication(s) with a "Known risk of Torsades de Pointes" per wwwcrediblemeds.org/ that cannot be discontinued or replaced 7 days prior to starting study drug by safe alternative medication.
* Inability to determine the QTcF interval
4. Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection, pulmonary hypertension)
5. History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
6. Known presence of significant congenital or acquired bleeding disorder unrelated to cancer
7. History of other active malignancy within 3 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively
8. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery)
9. Previous treatment with or known/ suspected hypersensitivity to asciminib or any of its excipients.
10. Participation in a prior investigational study within 30 days prior to randomization or within 5 half-lives of the investigational product, whichever is longer
11. Pregnant or nursing (lactating) women
12. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception.
Highly effective contraception methods include:
* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
* Female sterilization (have had surgical bilateral oophorectomy (with or without hysterectomy) total hysterectomy or bilateral tubal ligation at least six weeks before taking study treatment). In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
* Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject.
* Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception.
* In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks before taking study medication. In the case of oophorectomy alone, women are considered post-menopausal and not of child bearing potential only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
13. Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 3 days after stopping study (only for patients treated with asciminib). A condom is required for all sexually active male participants on asciminib treatment to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, these male participants must not donate sperm for the time period specified above.
14. If a patient is presenting with symptoms suggestive of possible COVID-19 infection, we advise ruling it out by appropriate testing recommended by health authorities.
* Nucleic acid amplification tests for viral RNA (polymerase chain reaction), in order to measure current infection with SARS-CoV-2
* Antigen tests for rapid detection of SARS-CoV-2
* Antibody (serology) tests to detect the presence of antibodies to SARS-CoV-2
1. Known second chronic phase of CML after previous progression to AP/BC
2. Previous treatment with a hematopoietic stem-cell transplantation
3. Cardiac or cardiac repolarization abnormality, including any of the following:
* History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG)
* Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block)
* QTcF at screening ≥450 msec (male patients), ≥460 msec (female patients)
* Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
* Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
* Concomitant medication(s) with a "Known risk of Torsades de Pointes" per wwwcrediblemeds.org/ that cannot be discontinued or replaced 7 days prior to starting study drug by safe alternative medication.
* Inability to determine the QTcF interval
4. Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection, pulmonary hypertension)
5. History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
6. Known presence of significant congenital or acquired bleeding disorder unrelated to cancer
7. History of other active malignancy within 3 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively
8. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery)
9. Previous treatment with or known/ suspected hypersensitivity to asciminib or any of its excipients.
10. Participation in a prior investigational study within 30 days prior to randomization or within 5 half-lives of the investigational product, whichever is longer
11. Pregnant or nursing (lactating) women
12. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception.
Highly effective contraception methods include:
* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
* Female sterilization (have had surgical bilateral oophorectomy (with or without hysterectomy) total hysterectomy or bilateral tubal ligation at least six weeks before taking study treatment). In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
* Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject.
* Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception.
* In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks before taking study medication. In the case of oophorectomy alone, women are considered post-menopausal and not of child bearing potential only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
13. Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 3 days after stopping study (only for patients treated with asciminib). A condom is required for all sexually active male participants on asciminib treatment to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, these male participants must not donate sperm for the time period specified above.
14. If a patient is presenting with symptoms suggestive of possible COVID-19 infection, we advise ruling it out by appropriate testing recommended by health authorities.
* Nucleic acid amplification tests for viral RNA (polymerase chain reaction), in order to measure current infection with SARS-CoV-2
* Antigen tests for rapid detection of SARS-CoV-2
* Antibody (serology) tests to detect the presence of antibodies to SARS-CoV-2
Minimum Eligible Age
18 Years
Maximum Eligible Age
99 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alaska Oncology and Hematology
Anchorage, Alaska, United States
Site Status
Arizona Oncology Associates
Phoenix, Arizona, United States
Site Status
Cancer Treatment Centers of America
Phoenix, Arizona, United States
Site Status
Pacific Shores Medical Group
Long Beach, California, United States
Site Status
Lundquist Inst BioMed at Harbor
Torrance, California, United States
Site Status
Rocky Mountain Cancer Centers
Boulder, Colorado, United States
Site Status
Memorial Cancer Institute
Hollywood, Florida, United States
Site Status
Florida Cancer Specialists
Sarasota, Florida, United States
Site Status
Florida Cancer Specialists-North
St. Petersburg, Florida, United States
Site Status
Florida Cancer Specialists East
Stuart, Florida, United States
Site Status
Florida Cancer Specialists Pan
Tallahassee, Florida, United States
Site Status
Indiana Blood and Marrow Institute
Beech Grove, Indiana, United States
Site Status
University of Kentucky
Lexington, Kentucky, United States
Site Status
Uni of Massachusetts Medical Center
Worcester, Massachusetts, United States
Site Status
Michigan Med University of Michigan
Ann Arbor, Michigan, United States
Site Status
Siteman Cancer Center
St Louis, Missouri, United States
Site Status
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Site Status
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Site Status
Uni of Cincinnati Medical Center
Cincinnati, Ohio, United States
Site Status
Oncology Hematology Care Inc
Cincinnati, Ohio, United States
Site Status
Northwest Cancer Specialists
Portland, Oregon, United States
Site Status
Texas Oncology
Dallas, Texas, United States
Site Status
Texas Oncology P A
Fort Worth, Texas, United States
Site Status
Univ of TX MD Anderson Cancer Cntr
Houston, Texas, United States
Site Status
Texas Oncology Northeast Texas
Tyler, Texas, United States
Site Status
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2681
A Plain Language Trial Summary is available on www.novctrd.com
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CABL001AUS04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia
NCT06629584
RECRUITING
PHASE2
Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs
NCT03106779
COMPLETED
PHASE3
A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
NCT04971226
ACTIVE_NOT_RECRUITING
PHASE3
Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia
NCT04925479
RECRUITING
PHASE1/PHASE2
Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
NCT03578367
COMPLETED
PHASE2
Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase
NCT05143840
RECRUITING
PHASE2
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
COMPLETED
PHASE2
Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib
NCT06516029
COMPLETED
Clinical Study of Asciminib in Previously Treated Indian Patients With Ph+ CML-CP Without T315I Mutation and in Patients With Ph+ CML-CP With T315I Mutation
NCT06427811
ACTIVE_NOT_RECRUITING
PHASE4
Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.
NCT06236724
RECRUITING
PHASE2
Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy
NCT00264160
COMPLETED
PHASE2/PHASE3
PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML
NCT06409936
RECRUITING
PHASE2
A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia
NCT06368414
NOT_YET_RECRUITING
PHASE2
Efficacy and Safety of LBH589 in Adult Patients With Refractory Chronic Myeloid Leukemia (CML) in Chronic Phase
NCT00451035
TERMINATED
PHASE2
Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL
NCT07250087
RECRUITING
PHASE1
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Did Not Respond to Imatinib Mesylate
NCT00100997
COMPLETED
PHASE1
Asciminib RMP Study
NCT05943522
RECRUITING
Asciminib Roll-over Study
NCT04877522
RECRUITING
PHASE4
Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database
NCT06148493
COMPLETED
CCI-779 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, or Chronic Myelogenous Leukemia in Blastic Phase
NCT00084916
COMPLETED
PHASE2
Asciminib Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML- CP in Real World Setting in France
NCT06092879
ACTIVE_NOT_RECRUITING
Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib
NCT01593254
COMPLETED
PHASE2
Frontline Asciminib Combination in Chronic Phase CML
NCT03906292
ACTIVE_NOT_RECRUITING
PHASE2
Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients
NCT00590187
COMPLETED
PHASE2