Low Dose Daunorubicin in Pediatric Relapsed/Refractory Acute Leukemia

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

In this pilot study, eligible pediatric patients will be treated with 5 consecutive days of low dose daunorubicin. All patients who receive low dose daunorubicin will be evaluated daily for potential toxicity during those 5 days. Once the patient has received 5 doses of daunorubicin, subsequent therapy will be at the discretion of the primary oncology team.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Mercy Hospital Kansas City
• Treatments: Daunorubicin

Criteria

Inclusion Criteria:

• Patients with pathologically confirmed ALL or AML, whose disease is refractory to two induction therapeutic attempts, or who are in 2nd or greater relapse, or who are in 1st relapse or refractory to a single therapeutic attempt but are unable to receive intensive therapy at the time of consent.

• All prior upfront therapies including bone marrow transplant are acceptable. Pulse steroids (of 5 days duration or less in the prior month) administered as part of a routine maintenance therapy are acceptable.

• Age 1 to 21 years of age, inclusive

• Established central catheter IV access

Exclusion Criteria:

• Females who are known to be pregnant or lactating

• Any Grade 3 or higher Cardiac Disorder per CTCAE version 5

• Patients with echocardiographic evidence of cardiomyopathy (shortening fraction <27% or ejection fraction <50%)

• Uncontrolled sepsis

• Absolute Blast Count >50 x10(3)/mcL at enrollment or on day 1 of study

• Direct hyperbilirubinemia >5mg/dL

• Grade 3 or higher anaphylaxis to daunorubicin

• Non-English speaking

• Patients, who in the opinion of the PI, are unable to tolerate any study-specific procedures

• Patients who have received cyclosporine, tacrolimus or other agents to prevent or treat graft-vs-host disease post bone marrow transplant in the last 14 days

• Concurrent investigational drugs or other chemotherapeutic agents (excluding hydroxyurea), immunotherapies or biosimilars during the 5 days of daunorubicin.

• Prior cumulative doses of anthracyclines will not be an exclusion regardless of the total cumulative dose previously received.