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Monoclonal Antibodies

Blinatumomab + TKI for Acute Lymphoblastic Leukemia

Phase 2

Waitlist Available

Led By Mark Geyer, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

ECOG performance status 0-2

Age ≥ 18 years of age

Must not have

Philadelphia chromosome-negative ALL

Patients with active hepatitis C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding the drug blinatumomab to standard treatment for Ph+ ALL can improve responses.

Who is the study for?

Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who haven't had treatment beyond corticosteroids or certain chemotherapies. Participants must be able to consent, have acceptable liver function and organ health, agree to use birth control during and after the study, and have a performance status indicating they are relatively active.

What is being tested?

The trial is testing blinatumomab combined with tyrosine kinase inhibitor therapy (like dasatinib) against standard care for Ph+ ALL. The goal is to see if adding blinatumomab improves outcomes compared to just corticosteroids plus TKI therapy.

What are the potential side effects?

Potential side effects include allergic reactions, liver enzyme changes, nerve damage symptoms like tingling or numbness, fatigue, headache, fever, bleeding complications and increased risk of infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and perform daily activities.

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I am 18 years old or older.

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I have been diagnosed with ALL and it's confirmed to be Philadelphia chromosome positive.

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I have only had steroids, hydroxyurea, or preventive brain/spinal cord chemo for my ALL.

Exclusion Criteria

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

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My leukemia is not caused by the Philadelphia chromosome.

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I have an active hepatitis C infection.

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My heart condition meets specific health criteria.

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I have an active hepatitis B infection.

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My leukemia is a type called mature B-cell ALL.

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I have cancer cells outside my bone marrow, including in my brain or spinal fluid.

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My cancer has a mutation resistant to dasatinib treatment.

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I cannot take medicine by mouth.

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I need continuous medication to suppress my immune system.

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I do not have any other active cancers.

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I do not have any untreated serious infections.

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I do not have any severe or uncontrolled neurological conditions.

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My kidney function is reduced with high creatinine and low GFR levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of evaluable patients achieving complete molecular response

Secondary study objectives

Frequency, severity, and co-occurrence of treatment-related grade 3-4 toxicities

Other study objectives

Frequency, type, and co-occurrence of ABL kinase mutations

Frequency, type, and co-occurrence of new somatic mutations

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Blinatumomab & Concurrent Oral Tyrosine Kinase Inhibitor (TKI)Experimental Treatment4 Interventions

Patients may receive steroids and hydroxyurea pre-study entry and receive a 7-day steroid prephase before starting TKI therapy. Planned initial TKI is dasatinib 140 mg daily; dasatinib dose may be reduced or TKI may be changed to a different agent under certain conditions. Induction consists of continuous TKI + 24 days of dexamethasone, followed by taper of dexamethasone, with bone marrow aspirate/biopsy (BMA) and CNS prophylaxis at days 22 and 43. Patients achieving morphologic complete response post-induction proceed to consolidation with up to 3 cycles of blinatumomab (28-day cycles, 14 days between cycles) + TKI, with BMA and CNS prophylaxis between cycles. Patients achieving complete molecular response may proceed to maintenance with up to 4 more cycles of blinatumomab (28-day cycles with 28 days between cycles) + TKI, with CNS prophylaxis between cycles and BMA after cycles 5 and 7. Patients can come off study to undergo allogeneic hematopoietic cell transplantation at any time.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blinatumomab

2014

Completed Phase 3

~1230

dasatinib

2011

Completed Phase 3

~2220