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RecruitingPhase 2

Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL)

A Multicenter Phase II Study of Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Physical exams, Biopsies, Heart tracing (ECG), Spinal tap (lumbar puncture)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "At specified time points, subjects will undergo the following procedures: collection of informed consent, medical history, demographics, ECOG performance, and physical exam including vital signs as well as neurological examination including examination of writing ability."
  • "Subjects will provide samples for complete blood count with differential and blood chemistry profile, have a bone marrow aspiration and biopsy and lumbar puncture will be performed per protocol or if clinically indicated, and/or ECG, Echocardiography, pulmonary function test will be performed only if medically indicated."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests blinatumomab given as a shot under the skin for adults with CD19-positive mixed phenotype acute leukemia (MPAL), a blood cancer. It checks how well the drug treats newly diagnosed cancer, clears small amounts left after treatment, or treats cancer that came back or did not respond.

This is a multicenter, non-randomized, open-label, phase II study evaluating blinatumomab administered subcutaneously in adult subjects with CD19+ MPAL. This trial consists of three cohorts of patients with CD19-positive MPAL, categorized as follows: 1. Cohort A: Newly diagnosed CD19+ MPAL in untreated patients who are either ≥ 75 years of age or have at least one coexisting condition precluding intensive chemotherapy. 2. Cohort B: Patients with CD19+ MPAL who have achieved complete remission (CR, CRh, or CRi) following at least one line of treatment but have detectable measurable residual disease (MRD) at a level of ≥ 0.1%, assessed using an assay with a minimum sensitivity of 0.01%. 3. Cohort C: Patients with CD19+ MPAL with morphologic relapsed or refractory (R/R) disease following at least one prior line of treatment. The Primary Objectives for each cohort are for Cohort A: to evaluate the efficacy of SC-blinatumomab in treatment; for Cohort B: to assess the ability of SC-blinatumomab to achieve MRD-negative CR; for Cohort C: to determine the efficacy of SC-blinatumomab in inducing CR, CRh, or CRi in patients. At specified time points, subjects will undergo the following procedures: collection of informed consent, medical history, demographics, ECOG performance, and physical exam including vital signs as well as neurological examination including examination of writing ability. Subjects will provide samples for complete blood count with differential and blood chemistry profile, have a bone marrow aspiration and biopsy and lumbar puncture will be performed per protocol or if clinically indicated, and/or ECG, Echocardiography, pulmonary function test will be performed only if medically indicated. The subcutaneous treatment will be given in both the inpatient and outpatient setting. For an individual subject the length of participation includes up to a 3-week screening period, up to a 13-month treatment period, and a safety follow-up visit (30 days after the last dose of study treatment), and a follow-up period.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must have confirmed MPAL with the CD19 marker and fit one of the three study groups below.
  • Group A: Your cancer is newly diagnosed and untreated. You cannot have intensive chemotherapy because you are 75 or older or have certain heart, lung, or other health problems.
  • Group B: After at least one treatment, your cancer is in remission, meaning signs of cancer have decreased or cleared. Sensitive testing must still find at least 0.1% remaining cancer.
  • Group C: Your cancer came back or did not respond after at least one treatment. You must wait long enough after most chemotherapy for the drugs to clear and recover to no more than mild side effects.
  • For Groups B and C, you must be able to care for yourself and be out of bed or a chair at least half the day. Liver and kidney blood tests must meet study limits.
  • If you had a donor stem cell transplant, it must have been at least 4 weeks ago. Any donor cells attacking your body must be no more than moderate. You must be off immune-suppressing drugs for at least 1 week, and certain ones for 4 weeks.
  • If leukemia affects your brain or spinal cord, symptoms must be stable and meet study limits. Testing of fluid around the brain and spinal cord must show no leukemia cells within 2 weeks before treatment.
  • You must understand and sign the consent form, follow study rules, and attend required clinic or hospital visits.

Who can't join

  • You are receiving another experimental drug or other cancer chemotherapy, radiation, or immune treatment at the same time. Steroids and hydroxyurea are allowed.
  • You have an active infection that is not controlled. You may join if treatment is keeping the infection under control.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* 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

Study sites (1)

WV