Actively Recruiting
Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2026-05-12
40
Participants Needed
2
Research Sites
247 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
Novartis Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.
CONDITIONS
Official Title
Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants 18 years or older with newly diagnosed or minimally pretreated Ph-positive ALL not suitable for intensive chemotherapy
- Participants 12 years or older with relapsed/refractory Ph-positive ALL or treated lymphoid blast phase CML
- Performance status 2 or better (ECOG) if 18 years or older, or Lansky 50 or higher if under 18
- Weight at least 40 kg
- Adequate liver function with bilirubin ≤ 2 x ULN (unless Gilbert's syndrome), ALT ≤ 3 x ULN, or AST ≤ 3 x ULN
- Adequate kidney function with creatinine clearance ≥ 30 mL/min
- Adequate pancreatic function with serum lipase and amylase < 1.5 x ULN
- Adequate cardiac function by clinical assessment
- Negative urine pregnancy test for females of childbearing potential
- Willingness to use effective contraception during and for 4 months after study
- Ability and willingness to sign informed consent
You will not qualify if you...
- Active serious infection uncontrolled by antibiotics
- Active secondary cancer other than skin cancer that may shorten survival to less than 1 year
- Active Grade III-V heart failure
- Prolonged QTc interval > 470 msec unless corrected or approved by cardiologist
- History or presence of serious CNS conditions like epilepsy, seizures, stroke, dementia, or psychosis (except active CNS leukemia)
- Treatment with investigational or chemotherapy agents within 7 days before study entry unless fully recovered or life-threatening disease
- Pregnant or lactating women; women must have negative pregnancy test and use contraception
- Men must understand risks to partners and use effective birth control
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, United States, 10467
Not Yet Recruiting
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Nicholas Short, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here