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Promising combo targets tough leukemia

NCT ID NCT07301424

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • University of Alberta

    Edmonton, Alberta, T6G 2G3, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.