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AflacLL1901 (CHOA-AML)

NCT04326439 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-06-15

Study results available
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Summary

The investigators propose to study an Aflac-AML chemotherapy backbone prospectively to validate its use in all pediatric AML and to further evaluate the cardiotoxicity with this approach for low risk AML.

Conditions

Interventions

DRUG

Cytarabine

100 mg/m²/dose every 12 hours IV Days 1-10

DRUG

Daunorubicin

50 mg/m²/dose IV Days 1, 3, 5

DRUG

Erwinase

25,000 International Units/m²/dose IM Days 2, 9

DRUG

Etoposide

150 mg/m²/dose IV Days 1-5

DRUG

Gemtuzumab ozogamicin

Administered as a single 3 mg/m2 dose of GO to be given between days 6-10 during Induction I for patients with CC genotype, in addition to ADE therapy.

PROCEDURE

Stem cell transplantation (SCT)

Transplantation of multipotent hematopoietic stem cells from bone marrow

DRUG

Sorafenib

200 mg/m2/dose daily, rounded to accommodate tablet size. The maximum dose will be 400 mg. Days 7 through 34.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Himalee Sabnis, MD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-24
Primary Completion
2022-03-15
Completion
2022-03-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04326439 on ClinicalTrials.gov