Blinatumomab for Treatment of R/R or MRD-positive CD19-Positive MPAL

• Status: Recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a research study to find out if a drug called blinatumomab is effective for treating patients with relapsed or refractory (R/R) or measurable residual disease (MRD) CD19-positive mixed phenotypic acute leukemia (MPAL). Measurable Residual Disease (MRD) means that there are a small number of cancer cells remaining after treatment

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland, Baltimore
• Treatments: Blinatumomab

Criteria

Inclusion Criteria:

• subjects must have histologically or cytologically confirmed R/R MPAL based on WHO criteria, OR MPAL in CR/CRh/CRi/CRp after at least one chemotherapy block of standard ALL or AML treatment with MRD positivity at a level of ≥ 0.1% using an assay with a minimum sensitivity of 0.01%

• Age 18 years and older

• 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 all immunosuppressive therapy

• Previous cytotoxic chemotherapy (except for hydroxyurea) must have been completed at least 2 weeks prior to day 1 of treatment on the study. subjects with hematologic malignancies are expected to have hematologic abnormalities at study entry.

• ECOG performance status < 3

• 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

• Subjects with a history of CNS leukemia must be clinically stable with a flow cytometric clear CSF in the 2 weeks prior to day 1 of blinatumomab administration. subjects with history of CNS leukemia in Cohort A should have received one dose of intrathecal (IT) 6 chemotherapy in the 4 weeks prior to day 1 of blinatumomab administration. Subject can receive subsequent prophylactic intrathecal chemotherapy.

• Female subjects of childbearing potential must have a negative pregnancy test

• 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

Exclusion Criteria:

• Subjects receiving any other investigational agents, or concurrent chemotherapy, radiation therapy, or immunotherapy not including corticosteroids or hydroxyurea

• Subjects with acute leukemia with any of the following cytogenetic abnormalities:

t(15;17)(q24;q21) PML/RARA, t(8;21)(q22;q22) RUNX1/RUNX1T1, inv(16)(p13q22)/t(16;16)(p13;q22) CBFB-MYH11

• A history or presence of clinically relevant CNS pathology (e.g., as epilepsy, paresis, aphasia, stroke, severe brain injuries, dementia, cerebellar disease, psychosis)

• Hyperleukocytosis with > 50,000 blasts/µL. Hydroxyurea for blast count control is permitted before starting treatment and up to maximum of 10 days after starting treatment on the study. The WBC need not reach 50,000/µL to start hydroxyurea during protocol; the decision to start hydroxyurea during this time is at the discretion of the treating physician

• Active, uncontrolled infection; subjects with infection under active treatment and controlled with antimicrobials are eligible

• Pregnant women

• Uncontrolled undercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled active seizure disorder, or psychiatric illness/social situations that per site Principal Investigator's judgment would limit compliance with study requirements