NCT00028418

Brief Summary

This is a dose-escalation study to determine the maximum tolerated dose and toxic effects of clofarabine in patients with chronic lymphocytic leukemia and other acute leukemias. Clofarabine is a synthesized hybrid nucleoside analog, which is believed to possess the better qualities of fludarabine and chlorodeoxyadenosine, the 2 most active agents against lymphoproliferative disorders. Thus, it is hoped that this drug will be more active and less toxic than similar drugs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 1999

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1999

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2002

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2002

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

March 25, 2015

Status Verified

November 1, 2001

First QC Date

January 4, 2002

Last Update Submit

March 24, 2015

Conditions

Hematologic NeoplasmsLymphoproliferative DisordersLeukemiaLeukemia, Lymphocytic, Chronic

Keywords

Acute LeukemiaChronic Lymphocytic LeukemiaAntineoplastic AgentsNucleosidesDose-Response Relationship, DrugCladribineFludarabine

Interventions

ClofarabineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of chronic lymphocytic leukemia
  • Diagnosis of other acute leukemia
  • At least 2 weeks since prior chemotherapy, immunotherapy, and/or radiotherapy
  • Recovered from toxic effects of prior therapy
  • Bilirubin no greater than 2 mg/dL
  • Creatinine no greater than 1.5 mg/dL

You may not qualify if:

  • Candidate for treatment of higher efficacy or priority
  • Pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hematologic NeoplasmsLymphoproliferative DisordersLeukemiaLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Clofarabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms by Histologic TypeLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesNucleotidesRibonucleotides

Study Officials

  • Hagop M. Kantarjian, M.D.

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2002

First Posted

January 9, 2002

Study Start

February 1, 1999

Study Completion

March 1, 2004

Last Updated

March 25, 2015

Record last verified: 2001-11

Locations

US(1)