NCT00939653

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

T2007-002 A Phase II Study of Clofarabine With Etoposide and Cyclophosphamide in Relapsed/Refractory AML (IND 104,650)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Therapeutic Advances in Childhood Leukemia Consortium · Academic / Other
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

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®).

Detailed description

Clofarabine, etoposide and cyclophosphamide have been used together in a phase I study to find out the highest doses of these drugs that can be safely given to children with relapsed or refractory leukemia. This study is a phase II study which will use the drugs to study how well these drugs work against AML. This study will also examine the safety of this drug combination.

Conditions

• Relapsed Acute Myelogenous Leukemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-07-10
• Primary completion: 2011-07-15
• Completion: 2011-07-15
• First posted: 2009-07-15
• Last updated: 2020-02-19
• Results posted: 2020-02-19

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study