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Leukemia drug given as a shot shows promise in early trial

NCT ID NCT07222579

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a drug called blinatumomab, given as a shot under the skin, for adults with a rare type of leukemia called mixed phenotype acute leukemia (MPAL). The trial includes three groups: newly diagnosed patients who cannot have strong chemo, patients in remission but with leftover cancer cells, and patients whose cancer came back or didn't respond to treatment. The goal is to see if the drug can help achieve remission or clear remaining cancer cells.

What this could mean

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

Active substance
blinatumomab (Blincyto®)
What this could lead to
If successful, this could offer a new treatment option for adults with a rare and hard-to-treat leukemia, potentially leading to remission without intensive chemotherapy.
What could go wrong
This is an early-phase trial with only 78 participants, so results may not apply to all patients. The drug may cause side effects like neurological problems or infections, and not everyone may respond.

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 78 people

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

Started

Jan 2026

Expected to finish

Aug 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: * General Criteria for all three Cohorts * Subjects must have histologically or cytologically confirmed MPAL based on 2022 WHO criteria * Subjects who have undergone allo-HSCT are eligible if they are ≥ 4 weeks post stem cell infusion, have no evidence of GVHD \> Grade 2, and are at least ≥ 1 week off of immunosuppressive therapy. Per FDA recommendation, patients should be off of calcineurin inhibitors (CNIs) for at least 4 weeks before receiving blinatumomab * Subjects with a CNS leukemia must be clinically stable (i.e., asymptomatic with no focal neurological signs and symptoms, or signs and symptoms unchanged over 4 weeks with no \> grade 2 manifestations) with a flow cytometric clear CSF in the 2 weeks prior to day 1 of SC-blinatumomab administration. * Ability to understand and willingness to sign a written informed consent document * Agree to comply with the study requirements and agree to come to the clinic/hospital for required study visits * Subjects with hematologic malignancies are expected to have hematologic abnormalities at study entry * Specific Criteria for Cohort A o Subjects should be ineligible for available induction therapy either if they are 75 years of age or older or if they have at least one of the following coexisting conditions precluding intensive chemotherapy: a history of CHF for which treatment is warranted or a report of EF ≤50% in the last 12 months, a history of chronic stable angina, a report of DLCO of ≤65% or FEV1 ≤65% in the last 12 months, ECOG performance status 3 or 4, Charlson comorbidity index (CCI) ≥3. * Specific Criteria for Cohort B * CD19+ MPAL in CR/CRh/CRi after at least one line of treatment with MRD positivity at a level of ≥0.1% using an assay with a minimum sensitivity of 0.01%. * ECOG performance status ≤2 * Subjects must have organ function as below: * Direct bilirubin ≤ 2.5 mg/dL * AST/ALT/Alkaline phosphatase ≤ 5 X institutional upper limit of normal * Serum creatinine ≤ 3 mg/dL * Specific Criteria for Cohort C * Confirmed R/R CD19+ MPAL * Previous cytotoxic chemotherapy (except for hydroxyurea) must have been completed by 5 half-lives of the drug(s) prior to day 1 of SC-blinatumomab. Per FDA recommendation, patients should have recovered to no more than Grade 1 toxicities from prior chemotherapy. * ECOG performance status ≤2 * Subjects must have organ function as below: * Direct bilirubin ≤ 2.5 mg/dL * AST/ALT/Alkaline phosphatase ≤ 5 X institutional upper limit of normal * Serum creatinine ≤ 3 mg/dL * Exclusion Criteria: * Criteria for all three Cohorts * Subjects receiving any other investigational agents, or concurrent chemotherapy, radiation therapy, or immunotherapy for cancer treatment not including corticosteroids or hydroxyurea * Active, uncontrolled infection; subjects with infection under active treatment and controlled with antimicrobials are eligible

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • West Virginia University Cancer Institute

    RECRUITING

    Morgantown, West Virginia, 26506, United States

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