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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00098033
Other study ID # 2127
Secondary ID
Status Completed
Phase Phase 2
First received December 2, 2004
Last updated March 24, 2015
Start date September 2002
Est. completion date September 2005

Study information

Verified date December 2004
Source FDA Office of Orphan Products Development
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility - 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
clofarabine


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Texas

References & Publications (1)

Cortes JE, Gandhi V, et al. Clofarabine (2-chloro-9-(deoxy-2-fluoro-b-D-arabinosfuranosyl)adenine) is active for patients with refractory or relapsed acute leukemia. #739 ASH 2002.

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