Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Blinatumomab for Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive

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.

Official registry: https://clinicaltrials.gov/study/NCT03263572 · M.D. Anderson Cancer Center · enrollment listed as 90

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Blinatumomab, Cytarabine, or Methotrexate. The registry lists allocation as na. 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.

They plan to enroll about 90 people at Houston. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

Phase II Study of the Combination of Blinatumomab and Ponatinib in Patients With Philadelphia Chromosome (Ph)-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL)

Interventions: Blinatumomab, Cytarabine, Methotrexate, Ponatinib

Primary outcome (registry wording): Complete molecular response (CMR) rate in newly diagnosed Ph-positive and/or BCR-ABL-positive acute lymphoblastic leukemia (ALL)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Diagnosis of one of the following:
  • Participants ≥ 18 years of age with relapsed/refractory Ph-positive ALL or with previously treated lymphoid accelerated or blast phase CML (Participants with lymphoid accelerated or blast phase CML will be evaluated separately)
  • Participants ≥ 18 years of age with ALL MRD positive (either by NGS or PCR or flowcytometry) or with previously treated lymphoid accelerated or blast phase CML (Participants with lymphoid accelerated or blast phase CML will be evaluated separately)
  • Performance status ≤ 2 (ECOG Scale)
  • 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

Public study contact (from the registry)

Elias Jabbour, MD

713-792-4764

ejabbour@mdanderson.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT03263572 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT03263572?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT03263572?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary