Trial Outcomes & Findings for ABL001 for the Treatment of Chronic Myeloid Leukemia in Patients Who Are on Therapy With Tyrosine Kinase Inhibitor (NCT NCT04216563)
NCT ID: NCT04216563
Last Updated: 2026-01-09
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
At 12 months from the start of the study
Results posted on
2026-01-09
Participant Flow
Participant milestones
| Measure |
Treatment (Asciminib)
Patients receive asciminib PO BID for up to 36 months while receiving standard of care dasatinib or nilotinib in the absence of disease progression or unacceptable toxicity. Patients may continue to receive asciminib after 36 months at the discretion of investigator.
Asciminib: Given PO
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ABL001 for the Treatment of Chronic Myeloid Leukemia in Patients Who Are on Therapy With Tyrosine Kinase Inhibitor
Baseline characteristics by cohort
| Measure |
Treatment (Asciminib)
n=7 Participants
Patients receive asciminib PO BID for up to 36 months while receiving standard of care dasatinib or nilotinib in the absence of disease progression or unacceptable toxicity. Patients may continue to receive asciminib after 36 months at the discretion of investigator.
Asciminib: Given PO
|
|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=8 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
49 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: At 12 months from the start of the studyOutcome measures
| Measure |
Treatment (Asciminib)
n=6 Participants
Patients receive asciminib PO BID for up to 36 months while receiving standard of care dasatinib or nilotinib in the absence of disease progression or unacceptable toxicity. Patients may continue to receive asciminib after 36 months at the discretion of investigator.
Asciminib: Given PO
|
|---|---|
|
Participants With a Molecular Response
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 4 years, 7 months and 16 daysTime from date of treatment start until the date of failure or death from any cause.
Outcome measures
| Measure |
Treatment (Asciminib)
n=7 Participants
Patients receive asciminib PO BID for up to 36 months while receiving standard of care dasatinib or nilotinib in the absence of disease progression or unacceptable toxicity. Patients may continue to receive asciminib after 36 months at the discretion of investigator.
Asciminib: Given PO
|
|---|---|
|
Event Free Survival
|
NA Months
Interval 0.4 to 34.0
OS median not reached due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 4 years, 7 months and 16 daysTime from date of treatment start until date of death due to any cause or last Follow-up.
Outcome measures
| Measure |
Treatment (Asciminib)
n=7 Participants
Patients receive asciminib PO BID for up to 36 months while receiving standard of care dasatinib or nilotinib in the absence of disease progression or unacceptable toxicity. Patients may continue to receive asciminib after 36 months at the discretion of investigator.
Asciminib: Given PO
|
|---|---|
|
Overall Survival
|
NA Months
Interval 28.0 to 55.0
OS median not reached due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 4 years, 7 months and 16 daysPopulation: Of the 7 participants, one participant has a suspected Major Molecular Response by 1.8 months evaluable for Treatment-free Remission
patients who achieved a Major Molecular response by 1.8 M from start of therapy and sustained for 27 months prior to TFR discontinuation.
Outcome measures
| Measure |
Treatment (Asciminib)
n=1 Participants
Patients receive asciminib PO BID for up to 36 months while receiving standard of care dasatinib or nilotinib in the absence of disease progression or unacceptable toxicity. Patients may continue to receive asciminib after 36 months at the discretion of investigator.
Asciminib: Given PO
|
|---|---|
|
Treatment-free Remission
|
1 Participants
|
Adverse Events
Treatment (Asciminib)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Asciminib)
n=7 participants at risk
Patients receive asciminib PO BID for up to 36 months while receiving standard of care dasatinib or nilotinib in the absence of disease progression or unacceptable toxicity. Patients may continue to receive asciminib after 36 months at the discretion of investigator.
Asciminib: Given PO
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Blood and lymphatic system disorders
Anemia
|
28.6%
2/7 • Number of events 2 • Up to 4 years, 7 months and 16 days
|
|
Psychiatric disorders
Anxiety
|
28.6%
2/7 • Number of events 2 • Up to 4 years, 7 months and 16 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Investigations
Blood bilirubin increased
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Injury, poisoning and procedural complications
Bruising
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Psychiatric disorders
Confusion
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Investigations
Creatinine increased
|
28.6%
2/7 • Number of events 2 • Up to 4 years, 7 months and 16 days
|
|
Gastrointestinal disorders
Dental caries
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Number of events 2 • Up to 4 years, 7 months and 16 days
|
|
Ear and labyrinth disorders
Ear pain
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
General disorders
Edema face
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
General disorders
Fatigue
|
28.6%
2/7 • Number of events 2 • Up to 4 years, 7 months and 16 days
|
|
General disorders
Fever
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
General disorders
Flu like symptoms
|
14.3%
1/7 • Number of events 2 • Up to 4 years, 7 months and 16 days
|
|
Nervous system disorders
Headache
|
57.1%
4/7 • Number of events 7 • Up to 4 years, 7 months and 16 days
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
42.9%
3/7 • Number of events 3 • Up to 4 years, 7 months and 16 days
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Investigations
Lipase increased
|
42.9%
3/7 • Number of events 4 • Up to 4 years, 7 months and 16 days
|
|
Investigations
Lymphocyte count decreased
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Investigations
Lymphocyte count increased
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Gastrointestinal disorders
Mucositis oral
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
28.6%
2/7 • Number of events 3 • Up to 4 years, 7 months and 16 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.6%
2/7 • Number of events 2 • Up to 4 years, 7 months and 16 days
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • Number of events 3 • Up to 4 years, 7 months and 16 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
General disorders
Non-cardiac chest pain
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Gastrointestinal disorders
Oral pain
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Gastrointestinal disorders
Pancreatitis
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Investigations
Serum amylase increased
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Infections and infestations
Sinusitis
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
28.6%
2/7 • Number of events 3 • Up to 4 years, 7 months and 16 days
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
42.9%
3/7 • Number of events 4 • Up to 4 years, 7 months and 16 days
|
|
Infections and infestations
Tooth infection
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • Number of events 3 • Up to 4 years, 7 months and 16 days
|
|
Investigations
Weight loss
|
14.3%
1/7 • Number of events 1 • Up to 4 years, 7 months and 16 days
|
Additional Information
Ghayas Issa MD, Associate Professor
The University of MD Anderson Cancer Center
Phone: 7133205722
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place