MedTrace Logo

A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL

NCT01483690 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-10-27

Study results available
· View outcomes & findings →

Summary

This is a pilot study using decitabine and vorinostat before and during chemotherapy with vincristine, dexamethasone, mitoxantrone, and peg-asparaginase in pediatric patients with acute lymphoblastic leukemia (ALL).

Conditions

Interventions

DRUG

Decitabine

10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19.

DRUG

Vorinostat

180 mg/m2/day (Max dose=400mg daily) given orally on days 2 through 7 and days 16 through 21.

DRUG

Vincristine

1.5 mg/m2/day (Max dose 2 mg) given IV push on days 10, 17, 24 and 31.

DRUG

Dexamethasone

20 mg/m2/day divided BID given orally on days 8 through 12 and 22 through 26.

DRUG

Mitoxantrone

10 mg/m2/day given on days 8 and 9 as a short IV infusion over 5-15 minutes; do not infuse over less than 3 minutes

DRUG

Pegaspargase

2500 international units/m2/day IM or IV on days 10 and 24.

DRUG

Methotrexate

Given intrathecally to all patients the dose defined by age below. * 8 mg for patients age 1-1.99 * 10 mg for patients age 2-2.99 * 12 mg for patients 3-8.99 years of age * 15 mg for patients \>9 years of age CNS 1 or 2 patients get doses on day 8, 22 and 35 and CNS 3 patients should get doses on day 8, 15, 22, 29 and 35

Sponsors & Collaborators

  • Therapeutic Advances in Childhood Leukemia Consortium

    lead OTHER

Principal Investigators

  • Michael Burke, MD · Medical College of Wisconsin

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
2011-12-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States
  • Australia

Study Locations

More Related Trials

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 NCT01483690 on ClinicalTrials.gov