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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2025
  • participants needed
    30
  • sponsor
    University of Maryland, Baltimore
Updated on 14 May 2022

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

Description

This is a multicenter, non-randomized, open-label, phase II study evaluating the efficacy of blinatumomab to achieve the following objectives:

  1. The best morphologic response after the first two cycles of therapy in subjects with morphologic R/R CD19-positive MPAL
  2. MRD-negativity in subjects with CD19-positive MPAL in CR, or CRh, or CRi or CRp after receiving 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%

The trial consists two groups (Group A and B) and three phases ( induction, consolidation and maintenance) of therapy. Subject will receive study drug blinatumomab by continuous IV infusion (CIV). Each treatment cycle consists of 28 days of blinatumomab CIV followed by a 14±3 days treatment-free interval for induction, 28±3 days treatment-free interval for consolidation, and 56±3 days treatment-free interval for maintenance

Blinatumomab is approved by Food and Drug Administration [FDA] and European Medicines Agency [EMA] for use in people with another type of acute leukemia called acute lymphoblastic leukemia (ALL) but not MPAL.

Details
Condition Mixed Phenotype Acute Leukemia (MPAL), Measurable Residual Disease (MRD)
Treatment BLINCYTO (Blinatumomab)
Clinical Study IdentifierNCT04827745
SponsorUniversity of Maryland, Baltimore
Last Modified on14 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects must have histologically or cytologically confirmed R/R CD19-positive MPAL based on the WHO criteria, OR CD19-positive MPAL in CR/CRh/CRi/CRp after at least one chemotherapy block of standard ALL or AML therapy with detectable MRD ≥ 0.1%. Primary refractory MPAL is defined by absence of CR/CRh/CRi/CRp after at least one cycle of standard AML/ALL induction therapy. A patient has relapsed MPAL if they achieved a CR/CRh/CRi/CRp after induction therapy (CR1) and has then relapsed during, or after continuation of therapy
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
Female subjects of childbearing potential must have a negative pregnancy test
Ability to understand and willingness to sign a written informed consent document
administration. Subjects with history of CNS leukemia in Cohort A should have
Agree to comply with the study requirements and agree to come to the clinic/hospital for required study visits
received one dose of intrathecal chemotherapy in the 4 weeks prior to day 1 of
blinatumomab administration. Subject can receive subsequent prophylactic
intrathecal chemotherapy

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)
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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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