Investigation of Clofarabine in Acute Leukemias

Sponsor

University of Texas (Other)

Overall Status

Completed

CT.gov ID

NCT00098033

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

The goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), and chronic myelogenous leukemia (CML) in accelerated and blastic phases.

Condition or Disease	Intervention/Treatment	Phase
Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Chronic Myelogenous Leukemia	Drug: clofarabine	Phase 2

Detailed Description

The specific aims of the project are (1) conduct the phase II study of clofarabine and evaluate the antileukemic efficacy in AML, ALL, and CML-accelerated and blastic phases in terms of complete response (CR) rate, response duration, and survival; and (2) analyze the relationship between cellular uptake and retention of clofarabine triphosphate (the active metabolite), inhibition of DNA synthesis, and clinical outcome.

Completion date provided represents the completion date of the grant per OOPD records

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Clinical and Pharmacodynamic Investigation of Clofarabine in Acute Leukemias

Study Start Date :

Sep 1, 2002

Study Completion Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Patient is diagnosed with AML, ALL, myelodysplastic syndrome (MDS), and CML in transformation (includes CML-blastic phase and CML-accelerated phase).
No prior chemo-, immuno-, or radio-therapy for 2 weeks before entering the study, unless progressive life-threatening leukemia as judged by the treated physician.
Adequate liver function (bilirubin </= 2 mg%) and renal function (creatinine </= 2 mg%).
Pregnant and lactating females not eligible.
Zubrod performance status 0-2
Adequate cardiac status
No life-threatening conditions (e.g. infections) which may cause death within 3 weeks.