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CompletedNCT00098033Updated Mar 25, 2015

Investigation of Clofarabine in Acute Leukemias

A Phase 2 interventional study of clofarabine in Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia and Chronic Myelogenous Leukemia, sponsored by University of Texas. Completed. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2015-03-25.

Sponsored by University of Texas · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Non-randomized
Ages
12 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Acute Myelogenous Leukemia
  • Acute Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia

Keywords

  • clinical
  • pharmacodynamics
  • investigational drug clofarabine
  • AML, ALL, CML-accelerated phase, CML-blastic phase
  • Chronic Myelogenous Leukemia - accelerated phase
  • Chronic Myelogenous Leukemia - blastic phase
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 64 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

University of Texas is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants

Interventions

  • Drugclofarabine
06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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.
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00098033
Lead sponsor
University of Texas
First posted
Dec 3, 2004
Start date
Sep 2002
Completion
Sep 2005
Last update
Mar 25, 2015

Study contacts

Hagop M Kantarjian, MD
principal investigator · M.D. Anderson Cancer Center
Jorge E Cortes, MD
study chair · M.D. Anderson Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2004. You cannot join it, but the record below documents what was studied.

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