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New drug combo aims to outsmart tough leukemia without chemo

NCT ID NCT04329325

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether adding blinatumomab (an immunotherapy) to standard targeted therapy (dasatinib) can improve treatment for adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The goal is to achieve a deep molecular response without using traditional chemotherapy. The study involves 17 participants and focuses on safety and how well the combination works as consolidation and maintenance therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
blinatumomab (a type of immunotherapy) and dasatinib (a targeted therapy pill)
What this could lead to
If successful, this combination could become a more effective, chemotherapy-free treatment option for people with Ph+ ALL, potentially leading to deeper remissions.
What could go wrong
This is a small, early-phase trial with only 17 participants, so results may not apply to everyone. The combination may cause serious side effects, and it is not yet known if it improves long-term survival.

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

17 people

The number who actually took part.

Started

Mar 2020

Expected to finish

Mar 2027

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: * Able to give informed consent * Age ≥ 18 years of age * Direct bilirubin ≤2x upper limit of normal (ULN), AST and ALT ≤10x upper limit of normal (ULN). Higher bilirubin and AST/ALT levels are acceptable if thought related to Ph+ ALL. * Histology confirmed by enrolling institution Confirmed diagnosis of acute lymphoblastic leukemia (ALL) by morphology, immunohistochemistry, and/or multiparameter flow cytometry, with confirmation of Philadelphia chromosome positivity (Ph+) by cytogenetic studies (karyotype/FISH), molecular studies (BCRABL1 fusion transcripts), or targeted RNA sequencing * No prior therapy for ALL beyond corticosteroids, hydroxyurea, or prophylactic intrathecal/intra-Ommaya chemotherapy Acceptable end-organ function (i.e. not meeting exclusion criteria below) * Amenable to practicing an effective method of birth control during treatment and for at least 3 months following treatment on study * ECOG performance status 0-2 Exclusion Criteria: * Philadelphia chromosome-negative ALL * Mature B-cell ALL (e.g. Burkitt leukemia/lymphoma) * Active extramedullary disease at time of study entry, including known CNS-3 disease (≥5 WBC/microliter and positive cytology or flow cytometry). Note: LP and/or CNS imaging prior to treatment initiation is not required, but if the patient is found to have active CNS-3 disease (by LP) or evidence of CNS involvement on imaging in the course of evaluation of clinical findings, enrollment is not permissible. * Presence of known ABL kinase mutations conferring resistance to dasatinib at time of study entry, including T315I mutation. Note: ABL mutation testing prior to treatment initiation is neither recommended nor required, but if results of such mutation testing are known, enrollment of a patient with known ABL kinase mutations conferring dasatinib resistance is not permissible. * Unable to tolerate oral medication. * Creatinine \>1.5x upper limit of normal and estimated GFR \<30 mL/min (based on 24-hour urine collection to determine creatine clearance or CKD-EPI equation) NOTE: Meeting EITHER the blood creatinine level standard OR the estimated GFR standard (based on 24 hour urine collection OR CKD-EPI equation) is required for eligibility. Subjects are excluded only if BOTH criteria are not met. * Heart disease meeting one or more of the following criteria: * New York Heart Association (NYHA) stage III or IV congestive heart failure * Myocardial infarction \<6 months prior to enrollment * History of clinically significant ventricular arrhythmia * History of cardiomyopathy with left ventricular ejection fraction ≤20% * Pre-treatment Fredericia-adjusted QTc (QTcF) of \>500 msec, unless the patient is thought to be an acceptable candidate for dasatinib after consultation with a cardiologist (including, but not limited to situations in which QTcF is thought not representative of true length of repolarization due to pre-existing bundle branch block or ventricular pacing) * Patients with active hepatitis B infection (as manifest by either detectable hepatitis B virus DNA by PCR and/or positivity for hepatitis B surface antigen) are ineligible * Patients with active hepatitis C infection (as manifest by detectable hepatitis C virus RNA by PCR) are ineligible. Patients with detectable antibodies to hepatitis C virus will be screened by PCR for evidence of active infection. * Patients with HIV infection are ineligible, unless on antiretroviral therapy with undetectable HIV RNA by PCR (using an assay with sensitivity to detect levels of ≥50 copies/mL) and otherwise eligible in the determination of the investigator. * Ongoing need for systemic T-cell suppressive therapy (e.g. corticosteroids, tacrolimus, cyclosporine for active autoimmune disease or prior solid organ transplantation) * Concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin * Uncontrolled systemic fungal, bacterial, viral or other infection * History or presence of uncontrolled or clinically significant neurological disorders such as generalized seizure disorder or severe brain injury * Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study.

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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.

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

More trials for these conditions

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