Uproleselan + Chemotherapy for Leukemia

Palo Alto (17 mi)

Overseen byMaria Luisa Sulis, MD

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a new drug called uproleselan combined with two chemotherapy drugs in patients whose leukemia has come back or doesn't respond to treatment. Uproleselan helps make the cancer cells more vulnerable to chemotherapy by preventing them from hiding in the bone marrow.

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

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

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

I can perform most of my daily activities without assistance.

I am under 18 years old.

My kidney function is normal or near normal.

Exclusion Criteria

I have been diagnosed with acute promyelocytic leukemia.

I do not have any infections that are not under control.

I have been diagnosed with juvenile myelomonocytic leukemia.

I am not taking medication to prevent graft-versus-host disease after a bone marrow transplant.

My cancer has only returned in my brain or testicles and is not responding to treatment.

I have a genetic condition that affects my bone marrow.

Treatment Details

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.

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 leucovorin PO or IV BID on days 1, 8, 15, 22, and 29.

Cytarabine is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Cytosar-U for: