Investigation of Clofarabine in Acute Leukemias

The University of Texas System (UT)

Status and phase

Completed

Phase 2

Conditions

Acute Lymphocytic Leukemia

Acute Myelogenous Leukemia

Chronic Myelogenous Leukemia

Treatments

Drug: clofarabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00098033

2127

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.