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T2007-002 Clofarabine, Etoposide, Cyclophosphamide in Relapsed Acute Myelogenous Leukemia (AML)

NCT00939653 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-02-19

Study results available
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Summary

Clofarabine is a drug approved by the FDA (Food and Drug Administration) for treating children (age 1-21) with leukemia. This research study will use clofarabine with two other cancer fighting drugs. Clofarabine will be used together with etoposide (VePesid®, VP-16) and cyclophosphamide (Cytoxan®).

Conditions

  • Relapsed Acute Myelogenous Leukemia

Interventions

DRUG

Clofarabine

40 mg/m2/day IV over 2 hours (given at hours 0 to 2) on days 1 through 5.

DRUG

Etoposide

100 mg/m2/day IV over 2 hours (given at hours 2 to 4) on days 1 through 5.

DRUG

Cyclophosphamide

440 mg/m2/day IV as a 30-60 minute infusion (given at hours 4 to 5) on days 1 through 5.

DRUG

Filgrastim

Administered in Courses 1 and 2 only. 5 micrograms/kg/day IV or SC will begin on Day 6 and end when the ANC is \> 1000 x 2 days.

DRUG

Cytarabine

Given intrathecally on day 1 at the dose defined by age below: 30 mg for patients age 1-1.99 50 mg for patients age 2-2.99 70 mg for patients \>3 years of age

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • Therapeutic Advances in Childhood Leukemia Consortium

    lead OTHER

Principal Investigators

  • Paul Gaynon, MD · Children's Hospital Los Angeles

  • Nobuko Hijiya, MD · Ann & Robert H Lurie Children's Hospital of Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-07-10
Primary Completion
2011-07-15
Completion
2011-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00939653 on ClinicalTrials.gov