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Monoclonal Antibodies

New Therapies for Acute Lymphoblastic Leukemia

Phase 2

Waitlist Available

Led By Seth Karol, MD, MSCI

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

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

Must have

Meeting specific criteria for lymphoblastic lymphoma

Age 1-18.99 years at the time of enrollment on INITIALL

Must not have

Current active autoimmune disease or history of autoimmune disease with potential for CNS involvement

History of venoocclusive disease/sinusoidal obstructive syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3.5 years after enrollment.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the use of two new therapies for children and young adults with a type of blood cancer called B-cell precursor acute lymphoblastic leukemia and lymphoma. The main goal is to see

Who is the study for?

This trial is for children and young adults newly diagnosed with B-cell precursor acute lymphoblastic leukemia or lymphoma. Participants should not have favorable genetic features and must be considered high-risk by the National Cancer Institute's criteria.

What is being tested?

The trial tests two immunotherapy drugs, inotuzumab and blinatumomab, during the first treatment phase (induction therapy). It aims to see if these drugs can lead to a higher rate of no detectable cancer cells compared to previous standard treatments.

What are the potential side effects?

Potential side effects include reactions related to the immune system attacking normal cells, increased risk of infections, liver problems, blood disorders, allergic reactions, and fatigue. The exact side effects will vary between patients.

Eligibility Criteria

Inclusion Criteria

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

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My condition meets the criteria for lymphoblastic lymphoma.

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I am between 1 and 18 years old.

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I have not had chemotherapy, except as part of the INITIALL trial.

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I have been diagnosed with B-ALL or lymphoblastic lymphoma.

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I am over 10 years old or have a high white blood cell count, or I meet specific high-risk criteria.

Exclusion Criteria

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

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I have an active autoimmune disease or a history of one that could affect my brain.

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I have had a condition where small veins in my liver were blocked.

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I am not willing to use birth control.

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I have a history of significant brain or nerve conditions.

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My heart condition is stable and my QTc is under 500 msec.

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I have an infection that is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3.5 years after enrollment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3.5 years after enrollment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 years after enrollment. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

End of induction minimal residual disease negative remission

Secondary study objectives

Compare significant toxicities experienced to those on Total 17

Comparison of MRD-negative rates to those on Total 17

Event free survival (EFS)

+1 more

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: SJALL23H Treated PatientsExperimental Treatment13 Interventions

All eligible patients receive intervention according to the Detailed Description section with the following: Induction: Dexamethasone, Vincristine, Inotuzumab, Blinatumomab, Dasatinib, IT MHA. Early Post Induction: Cyclophosphamide, Cytarabine, Inotuzumab, Methotrexate, IT MHA, Dasatinib, Blinatumomab, 6-mercaptopurine, Dexamethasone, Vincristine, Daunorubicin, Calaspargase. Maintenance: Dexamethasone, Vincristine, Methotrexate, 6-mercaptopurine, Thioguanine, Dasatinib, IT MHA.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

6-Mercaptopurine

2011

Completed Phase 4

~350

Daunorubicin

2013

Completed Phase 4

~5040