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Dasatinib in Combination With Chemotherapy for Relapsed or Refractory Core Binding Factor Acute Myeloid Leukemia

NCT02680951 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-04-19

No results posted yet for this study

Summary

This study will examine the appropriate dose and side effects of dasatinib, when it is given with the standard of care chemotherapy for children and adolescents with Acute Myeloid Leukemia (AML).

Conditions

Interventions

DRUG

Dasatinib

Administered orally on a once daily schedule based on the dose level assigned to the patient at enrollment (60, 80, or 100mg/m2/day). Patients may adjust the time they take dasatinib as long as they take the drug approximately every 24 hours

DRUG

Fludarabine

30 mg/m2/dose, intravenous infusion over 30 minutes, once daily, on days 1 to 5, total 5 doses Participants with body weight less than 12Kg, the fludarabine dose will be corrected as follows: \[weight (Kg) x dose (per m2)\] divided by 30

DRUG

Cytarabine

2000 mg/m2/dose intravenous infusion over 1 to 3 hours, starting 4 hours after the beginning of fludarabine, once daily, on days 1 to 5, total 5 doses Participants with body weight less than 12Kg, the cytarabine dose will be corrected as follows: \[weight (Kg) x dose (per m2)\] divided by 30

DRUG

Idarubicin

8mg/m2/dose intravenous infusion over 15 minutes, once daily, on days 3 to 5, total 3 doses Participants with body weight less than 12Kg, the idarubicin dose will be corrected as follows: \[weight (Kg) x dose (per m2)\] divided by 30

DRUG

Intrathecal (IT) cytarabine

Given intrathecally to all participants on day 1 of course 1 and 2. Omit on day 1 of course 1 if participant received IT therapy within 7 days prior to study enrollment. Intrathecal chemotherapy may be given during the end of course 1 disease evaluation (spinal fluid and bone marrow aspiration) and may be repeated every 7 days with bone marrow evaluations per institutional preference. Cytarabine dose defined by age: * 30 mg for patients age 1 - 1.99 * 50 mg for patients age 2 - 2.99 * 70 mg for patients ≥3 years of age The participant may receive intrathecal triple therapy (ITT) if persistent blasts are present in the cerebral spinal fluid (CSF) based on the treating physician's clinical judgment.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Melinda Pauly, MD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-12-15
Completion
2017-12-15
FDA Drug
Yes

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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 NCT02680951 on ClinicalTrials.gov