Study of Blinatumomab, Methotrexate, Cytarabine, and Ponatinib for ALL
This study is looking at how well a combination of treatments works for adults with a type of blood cancer called acute lymphoblastic leukemia (ALL). This includes ALL that has a specific genetic change called Philadelphia chromosome (Ph)-positive or BCR-ABL positive, or ALL that has come back or isn't responding to other treatments. The treatments being studied are blinatumomab (an immunotherapy that helps your body's immune system fight cancer), methotrexate and cytarabine (chemotherapy drugs that stop cancer cells from growing), and ponatinib (a drug that blocks enzymes cancer cells need to grow). Researchers will measure how many patients have a complete molecular response (no detectable cancer cells) or an overall response (cancer shrinking or disappearing). The study aims to enroll 90 participants and its current status is unclear.
- Study design
- This interventional study plans to enroll 90 participants. It is testing a combination of four drugs for specific types of acute lymphoblastic leukemia.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for relapse or death for up to 6 years after achieving a complete response.
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NCT03263572
Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia
Recruiting
PHASE2Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~90 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:BlinatumomabCytarabineMethotrexatePonatinib
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete molecular response (CMR) rate in newly diagnosed Ph-positive and/or BCR-ABL-positive acute lymphoblastic leukemia (ALL)
Measured over At 18 weeks
+4 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Elias Jabbour · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Are postmenopausal for at least 1 year before the screening visit, OR
Are surgically sterile, OR
If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse 7. Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:
Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or
Agree to completely abstain from heterosexual intercourse 8. Adequate cardiac function as assessed clinically by history and physical examination. 9. Signed informed consent
Exclusion
Myocardial infarction (MI), stroke, or revascularization within 3 months
Unstable angina or transient ischemic attack
Congestive heart failure prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards prior to enrollment
Diagnosed or suspected congenital long QT syndrome
Clinically significant atrial or ventricular arrhythmias (such as artrial fibrillation, ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) as determined by the treating physician
Prolonged QTc interval on pre-entry electrocardiogram (\> 470 msec) unless corrected after electrolyte replacement or approved by cardiologist
Significant venous or arterial thromboembolism including deep venous thrombosis or pulmonary embolism. Participants with a history of treated prior superficial or catheter associated will not be considered as significant embolism and after discussion with PI will not be excluded from eligibility.
Uncontrolled hypertension (diastolic blood pressure \>90mmHg; systolic \>140mmHg). Participants with hypertension should be under treatment on study entry to effect blood pressure control 8. History or presence of clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (grade 3 or above) CNS events including ICANS from prior CART or other T cell engager therapies. Participants with active CNS leukemia - will NOT be excluded 9. Current autoimmune disease or history of autoimmune disease with potential CNS involvement 10. Treatment with any investigational antileukemic agents or chemotherapy agents within 2 weeks prior to study entry, unless full recovery from side effects has occurred or participant has rapidly progressive disease judged to be life-threatening by the investigator. 11. 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. 12. History of significant bleeding disorder unrelated to cancer, including:
Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) 13. Participants with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia. 14. Known active infection with HIV, HBV, HCV.
What this trial measures
- Complete molecular response (CMR) rate in newly diagnosed Ph-positive and/or BCR-ABL-positive acute lymphoblastic leukemia (ALL)At 18 weeks
- Overall response rate (ORR) in relapsed/refractory ALLAt 12 weeks
This is defined as the percentage of patients achieving complete remission (CR) or CR with incomplete blood count recovery (CRi).
- Relapse-free survivalFrom documented complete response until relapse or death, assessed up to 6 years
- Event-free survivalFrom first day of treatment until any failure (resistant disease, relapse, or death), assessed up to 6 years
- Overall survivalFirst day of treatment to time of death from any cause, assessed up to 6 years