Nivolumab + 5-azacytidine for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Therapeutic Advances in Childhood Leukemia Consortium

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a phase I/II Study of Nivolumab in Combination with 5-azacytidine in pediatric patients with relapsed/refractory acute myeloid leukemia

Research Team

Eligibility Criteria

This trial is for pediatric patients aged 1 to 30 with relapsed/refractory acute myeloid leukemia (AML). Eligible participants may have had multiple treatment attempts or stem cell transplants, provided they meet recovery and organ function criteria. They must not be pregnant, breastfeeding, or have certain infections or autoimmune diseases.

Inclusion Criteria

I am between 1 and 30 years old.

It has been over 42 days since my last immunotherapy treatment.

I agree not to breastfeed while participating in this study.

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Exclusion Criteria

Pregnant or breastfeeding.

I had a stem cell transplant less than 100 days ago, or I have active GVHD, or I had severe GVHD in the past, or I am on immune suppression.

I have never been treated with nivolumab.

See 12 more

Treatment Details

Interventions

5-azacytidine (Anti-metabolites)
Nivolumab (Monoclonal Antibodies)

Trial OverviewThe study tests the combination of Nivolumab and 5-azacytidine in children who've seen their AML return after treatment or didn't respond to initial treatments. It's a phase I/II trial aiming to find out how safe this combo is and how well it works against AML.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Open label designExperimental Treatment2 Interventions

Nivolumab and 5-azacytidine,

5-azacytidine is already approved in Canada, Japan for the following indications: