Leukemia drug given as a shot shows promise in early trial
NCT ID NCT07222579
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
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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 78 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Aug 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: * 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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
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Contact
Email: •••••@•••••
Locations
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West Virginia University Cancer Institute
RECRUITINGMorgantown, West Virginia, 26506, United States
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