Promising combo targets tough leukemia
NCT ID NCT07301424
First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times
Summary
This study tests a new way to treat a fast-growing blood cancer called BCR-ABL positive B-cell acute lymphoblastic leukemia. About 80 adults will receive two drugs: ponatinib pills and blinatumomab injections under the skin. The goal is to see if this combination can control the cancer and reduce side effects. Participants will need to take ponatinib for 5 years, so this is a disease-control approach, not a cure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Ph positive \[either t(9;22) and/or BCR-ABL1 positive\] ALL, CD19 positive 2. Age ≥18 years at time of informed consent 3. No prior induction treatment for ALL. A brief corticosteroid pre-phase (\< 1 week), or hydroxyurea for cytoreduction or symptom control is permitted. 3\. Greater than or equal to 5% blasts in the BM. 4\. Performance status ≤2 (ECOG Scale, see Appendix IV) 5\. Adequate organ function: 5.1.5.1 Hepatic: Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related): Total serum bilirubin less than 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome or Meulengracht disease Alanine aminotransferase (ALT) less than 3 x ULN Aspartate aminotransferase (AST) less than 3 x ULN 5.1.5.2 Pancreatic: * Serum lipase less than 2 x ULN 5.1.5.3 Renal: * Estimated Creatinine clearance ≥ 40 mL/min 5.1.5.4 Cardiac: * Left ventricular ejection fraction \> 40% Exclusion Criteria: 1. Uncontrolled infection 2. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus 3. Presence of cardiovascular disease of clinical relevance within the past 3 months. This includes: 5.2.3.1 Unstable angina 5.2.3.2 Myocardial infarction 5.2.3.3 Transient ischemic attack or stroke 5.2.3.4 Peripheral vascular infarction, claudication and/or revascularization 5.2.3.5 Symptomatic congestive heart failure 5.2.3.6 Clinically significant significant atrial/ventricular tachyarrhythmias 5.2.3.7 Venous thromboembolic event requiring systemic anticoagulation Please consult the sponsor if there are specific concerns outside of these criteria 4. Uncontrolled hypertension 5. History or presence of clinically relevant CNS pathology or event. This may include, for example: epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychosis. Before excluding a potential subject, please consult the sponsor. 6. Any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol. 7. History of malignancy other than ALL within 3 years prior to start of protocol-specified therapy except for: * malignancy treated with curative intent and with no known active disease present for 3 years before enrollment, and felt to be at low risk for recurrence by the treating physician * adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease * adequately treated cervical carcinoma in situ without evidence of disease * adequately treated breast ductal carcinoma in situ without evidence of disease * prostatic intraepithelial neoplasia without evidence of prostate cancer 8. Prior hematologic malignancy and/or alloSCT; this includes known CML 9. Concurrent or prior (within 30 days) treatment with another investigational agent or study drug 10. Female subject is pregnant or breastfeeding or planning to become pregnant breastfeed during treatment, and for an additional 4 months after the last dose of protocol-specified therapy 11. Inability to swallow or absorb tablets 12. Subject considered unsuitable for study for any other reason in the physician's best judgement. Before excluding a potential subject, please consult the sponsor.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Alberta
Edmonton, Alberta, T6G 2G3, Canada
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