Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia C… (NCT06308588) | Clinical Trial Compass
RecruitingPhase 1/2
Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
United States40 participantsStarted 2024-08-05
Plain-language summary
To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosis of one of the following:
. Performance status ≤2 (ECOG Scale) if age ≥18 years or Lansky ≥50 if age \<18 years
. Weight ≥40kg
. Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):
. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome
. Alanine aminotransferase (ALT) ≤ 3 x ULN, OR
. Aspartate aminotransferase (AST) ≤ 3 x ULN
. Adequate renal function defined as:
Exclusion criteria
. Active serious infection not controlled by oral or intravenous antibiotics.
. Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase I/II trial primarily measuring safety, what is currently known about the risks of combining blinatumomab and asciminib, and how does the early-phase nature of this study affect the balance between potential benefit and unknown side effects for my specific situation?
2Blinatumomab is given as a continuous IV infusion and can cause serious side effects like cytokine release syndrome and neurological problems — given my overall health, do you think I could tolerate this treatment, and what monitoring would be in place to catch those problems early?
3Asciminib works differently from older BCR-ABL inhibitors by targeting the STAMP site, which may help overcome resistance — could you explain whether my specific Philadelphia chromosome mutation or any prior treatment history might affect how well this combination could work for me?
4Are there established standard-of-care treatments for Ph+ ALL that I should consider first before enrolling in an early-phase trial where the optimal dose and long-term outcomes are still being determined?
5What would the practical day-to-day demands of participating in this trial look like — things like how often I'd need to come in, how long the infusions take, and whether the schedule is realistic given my work and family situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and adverse events (AEs)
Timeframe: Through study completion; an average of 1 year.
. Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.
. Prolonged QTc interval on pre-entry electrocardiogram (\> 470 msec) unless corrected after electrolyte replacement or approved by cardiologist
. History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. (Participants with active CNS leukemia will NOT be excluded)
. Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator. Cytarabine 2 g/m2 (or alternative) for cytoreduction is permitted.
. Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.