Actively Recruiting
Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2026-02-25
90
Participants Needed
1
Research Sites
521 weeks
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
This phase II trial studies how well blinatumomab, methotrexate, cytarabine, and ponatinib work in treating patients with Philadelphia chromosome (Ph)-positive, or BCR-ABL positive, or acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab, methotrexate, cytarabine, and ponatinib may work better in treating patients with acute lymphoblastic leukemia.
CONDITIONS
Official 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
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 or blast phase chronic myelogenous leukemia
- Adults aged 18 years or older with relapsed/refractory Ph-positive ALL or previously treated lymphoid accelerated or blast phase CML
- Adults aged 18 years or older with ALL minimal residual disease positive or previously treated lymphoid accelerated or blast phase CML
- ECOG performance status of 0 to 2
- Adequate liver function unless abnormality is related to leukemia
- Serum lipase and amylase levels at or below 1.5 times the upper limit of normal
- Negative pregnancy test for females of childbearing potential
- Female participants must be postmenopausal for at least 1 year, surgically sterile, or 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 effective 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 oral or intravenous antibiotics
- History of acute pancreatitis within the past year or chronic pancreatitis
- History of alcohol abuse
- Uncontrolled hypertriglyceridemia (triglycerides above 650 mg/L)
- Active secondary cancer other than certain skin cancers expected to shorten survival to less than 1 year
- Severe cardiac failure (Grade III-V) or uncontrolled cardiovascular disease
- Recent myocardial infarction, stroke, unstable angina, or significant arrhythmias
- Prolonged QTc interval unless corrected or approved by cardiologist
- Significant venous or arterial thromboembolism unless treated and approved by investigator
- Uncontrolled hypertension despite treatment
- History or presence of severe central nervous system disorders or events except active CNS leukemia
- Current or history of autoimmune disease involving the central nervous system
- Treatment with investigational antileukemic or chemotherapy agents within 2 weeks prior to study entry unless fully recovered
- Pregnant or breastfeeding women
- History of significant bleeding disorders unrelated to cancer
- Significant pleural or pericardial effusions unless related to leukemia
- Known active infection with HIV, HBV, or HCV
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Elias Jabbour, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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