Molecular characterization and predictors of relapse in patients with Ph + ALL after frontline ponatinib and blinatumomab.
Nicholas J Short, Hagop Kantarjian, Ken Furudate...
https://pubmed.ncbi.nlm.nih.gov/40369607Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID03263572
Phase II Study of Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Philadelphia Chromosome-Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2026-05-20
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well a combination of blinatumomab, methotrexate, cytarabine, and ponatinib works in treating patients with Philadelphia chromosome (Ph)-positive, BCR-ABL positive, or relapsed/refractory acute lymphoblastic leukemia (ALL). This phase II study aims to measure complete molecular response rates, overall response rates, relapse-free survival, event-free survival, and overall survival in these patients. The study also explores genetic factors and immune cell changes related to treatment outcomes. Participants receive blinatumomab intravenously nonstop on days 1-28 of cycles 1 through 5. Methotrexate and cytarabine are given intrathecally by spinal tap on days 1, 15, and 29 of cycles 1 through 4. Ponatinib is taken orally every day. Each treatment cycle lasts 6 weeks, and treatment continues unless the disease worsens or side effects become unacceptable. During the study, patients will have regular assessments including blood tests and molecular evaluations to track leukemia response and detect minimal residual disease. Follow-up visits occur 30 days after treatment ends and then every 6 months to monitor long-term outcomes and safety. The study monitors event-free survival and overall survival for up to 6 years after treatment begins, ensuring thorough evaluation of the treatment effects over time.
CONDITIONS
Brief Title
Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with newly diagnosed Ph-positive or BCR-ABL positive acute lymphoblastic leukemia or lymphoid accelerated/blast phase chronic myelogenous leukemia
- Adults aged 18 years or older with relapsed or refractory Ph-positive acute lymphoblastic leukemia or previously treated lymphoid accelerated/blast phase chronic myelogenous leukemia
- Adults aged 18 years or older with acute lymphoblastic leukemia who are minimal residual disease positive
- Performance status of 2 or less on the ECOG scale
- Adequate liver function with bilirubin ≤ 2 times upper limit of normal (ULN) unless due to Gilbert's syndrome, and ALT or AST ≤ 3 times ULN
- Adequate pancreatic function with serum lipase and amylase ≤ 1.5 times ULN
- Females of childbearing potential must have a negative pregnancy test and agree to use two effective contraception methods or abstain from heterosexual intercourse during the study and 4 months after last dose
- Male participants must agree to use barrier contraception or abstain from heterosexual intercourse during the study and 4 months after last dose
- Adequate cardiac function as assessed clinically
- Signed informed consent
You will not qualify if you...
- Active serious infection not controlled by antibiotics
- History of acute pancreatitis within 1 year or chronic pancreatitis
- History of alcohol abuse
- Uncontrolled hypertriglyceridemia (triglycerides > 650 mg/L)
- Active secondary malignancy other than skin cancer expected to shorten survival to less than 1 year
- Active Grade III-V cardiac failure
- Uncontrolled or active cardiovascular disease including recent myocardial infarction, unstable angina, congestive heart failure, arrhythmias, prolonged QTc interval, significant thromboembolism, or uncontrolled hypertension
- History or presence of significant CNS pathology or severe CNS events, excluding active CNS leukemia
- Current or history of autoimmune disease with potential CNS involvement
- Treatment with investigational or chemotherapy agents within 2 weeks prior to study entry unless fully recovered or rapidly progressive disease
- Pregnant or lactating women
- History of significant bleeding disorders unrelated to cancer
- Significant pleural or pericardial effusions unless secondary to leukemia
- Known active infections with HIV, HBV, or HCV
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 30 weeks (5 cycles of 6 weeks each)
Participants receive blinatumomab intravenously nonstop on days 1-28 of cycles 1-5, methotrexate and cytarabine intrathecally on days 1, 15, and 29 of cycles 1-4, and ponatinib orally daily. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Regular visits during each 6-week cycle for treatment and assessments
Follow-up
Duration - Up to 6 years
After completing study treatment, participants are followed up at 30 days and then every 6 months to monitor health and disease status.
1 visit at 30 days post-treatment and then visits every 6 months
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Loading map...
Research Team
E
Elias Jabbour, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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
Published Research Related To This Trial
Results of the Simultaneous Combination of Ponatinib and Blinatumomab in Philadelphia Chromosome-Positive ALL.
Hagop Kantarjian, Nicholas J Short, Fadi G Haddad...
https://pubmed.ncbi.nlm.nih.gov/39028925Ponatinib and blinatumomab for Philadelphia chromosome-positive acute lymphoblastic leukaemia: a US, single-centre, single-arm, phase 2 trial.
Elias Jabbour, Nicholas J Short, Nitin Jain...
https://pubmed.ncbi.nlm.nih.gov/36402146