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Bi-specific T-cell Engager (BiTE)

BLINCYTO for Leukemia

Phase 2

Waitlist Available

Led By Ashkan Emadi, MD, PhD

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years and older

ECOG performance status < 3

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug to see if it's effective in treating patients with a certain type of leukemia that has come back or hasn't responded to treatment, or where there are still a small number of cancer cells remaining after treatment.

Who is the study for?

Adults with relapsed or refractory CD19-positive mixed phenotypic acute leukemia (MPAL) or those in remission but with detectable cancer cells after treatment. Participants must be over 18, have stable vital organ functions, and women of childbearing age must test negative for pregnancy. Those who've had a stem cell transplant should be past certain recovery milestones.

What is being tested?

The trial is testing the effectiveness of blinatumomab for patients with specific types of acute leukemia that are either not responding to standard treatments or have lingering cancer cells post-treatment. The study focuses on how well this drug can treat these conditions.

What are the potential side effects?

Blinatumomab may cause side effects such as allergic reactions, fever, headache, nausea, fatigue, and infections among others. Side effects vary from person to person based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself but may not be able to do heavy physical work.

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I had a stem cell transplant over 4 weeks ago, no major graft-vs-host disease, and stopped immunosuppressants for over a week.

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My mixed phenotype acute leukemia (MPAL) had responded to initial treatment but has now returned.

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I finished chemotherapy (except hydroxyurea) 2 weeks before starting the study and may have blood cell count issues due to my blood cancer.

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My leukemia did not respond to the first treatment cycle.

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My cancer is CD19-positive and either relapsed or didn't respond to treatment, or is in remission but still shows minimal signs of disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My acute leukemia has specific genetic changes.

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I am not currently on any experimental treatments or receiving chemotherapy, radiation, or immunotherapy.

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I have a significant brain condition like epilepsy, stroke, or dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cohort A response rate

Cohort B response rate

Secondary study objectives

Cohort A survival

Cohort B survival

Other study objectives

CD 19 measurement

CD3-positive measurement

Leukemic blasts evaluation

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Subjects with R/R CD19-positive MPALExperimental Treatment1 Intervention

Cohort A: Evaluate the efficacy of blinatumomab to achieve the best morphologic response after the first two cycles of therapy in subjects with morphologic R/R CD19-positive MPAL * The treatment of blinatumomab consists of induction, consolidation and maintenance 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 * The initial dose of blinatumomab is 9 mcg/day for 7 days. The target dose for rest of treatment is 28 mcg/day

Group II: Subjects with CD19-positive MPAL in CR/CRh/CRi/CRp and detectable MRDExperimental Treatment1 Intervention

Cohort B: Evaluate the efficacy of blinatumomab to achieve 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 treatment of blinatumomab consists of induction, consolidation and maintenance 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. * The dose of blinatumomab is 28 mcg/day

0 / 10Eligibility criteria met