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Anti-metabolites

Uproleselan + Chemotherapy for Leukemia

Phase 1

Recruiting

Led By Maria Luisa Sulis

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

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

Must have

Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life

Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to cycle 1 (28 days)

Awards & highlights

Study Summary

This trial tests if a new drug combo can safely and effectively treat relapsed or refractory leukemia.

Who is the study for?

This trial is for patients under 18 with acute myeloid leukemia, myelodysplastic syndrome, or mixed phenotype acute leukemia that's relapsed or refractory and expresses E-selectin ligand. They must have recovered from previous cancer treatments, meet specific blood count criteria, and not been exposed to uproleselan before. Pregnant individuals or those unable to follow the study plan are excluded.Check my eligibility

What is being tested?

The trial tests the highest safe dose of uproleselan combined with fludarabine and cytarabine in young patients whose leukemia cells express a certain protein. The goal is to see if this combination can better target cancer cells in the bone marrow compared to standard chemotherapy alone.See study design

What are the potential side effects?

Potential side effects may include reactions at the infusion site, changes in blood counts leading to increased infection risk, liver issues indicated by altered blood tests, heart function changes detectable by echocardiogram or radionuclide study, fatigue, nausea, and potential risks during pregnancy.

Eligibility Criteria

Inclusion Criteria

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

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My condition has no cure or treatments that would extend life with good quality.

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My bilirubin levels are within the normal range for my age.

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My cancer returned outside the bone marrow after a complete remission.

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I have had a stem cell transplant, with or without full-body radiation.

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My leukemia has not responded to treatment after a second relapse.

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I can perform most of my daily activities without assistance.

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I am under 18 years old.

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My kidney function is normal or near normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to cycle 1 (28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to cycle 1 (28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to cycle 1 (28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the plasma concentration versus time curve of Uproleselan

Dose Limiting toxicity of uproleselan

Elimination half-life of Uproleselan

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (uproleselan, fludarabine, cytarabine)Experimental Treatment5 Interventions

Patients receive uproleselan IV QD over 20 minutes on day 1 and IV over 20 minutes BID on days 2-8, fludarabine IV QD over 30 minutes on days 2-6, and high dose cytarabine IV QD over 1-3 hours on days 2-6. Patients also receive cytarabine IT on day 0 then weekly starting on day 7-28 or ITT on day 0 then weekly starting on day 7-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients (with down syndrome only) receive leuvoorine PO or IV BID on days 1, 8, 15, 22, and 29.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

Cytarabine

2016

Completed Phase 3

~3310