NCT00044889

Brief Summary

Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This is a single arm, open-label, Phase II study of CLOFARABINE in adult patients with refractory or relapsed acute myelogenous leukemia (AML). Qualified patients must be refractory to one or two induction regimens, or have relapsed \< one year from the date of confirmation of the initial complete remission (CR). There will be two phases in this study - an Induction phase and a Consolidation phase.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2002

Shorter than P25 for phase_2

Geographic Reach
1 country

12 active sites

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

May 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 9, 2002

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

March 19, 2014

Status Verified

March 1, 2014

First QC Date

September 6, 2002

Last Update Submit

March 17, 2014

Conditions

Acute Myelogenous Leukemia

Keywords

CLO221clolar

Interventions

clofarabine (IV formulation)DRUG

Eligibility Criteria

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

You may not qualify if:

  • Diagnosis of AML according to FAB classification
  • Must not be eligible for therapy of higher curative potential, and must be in first or subsequent relapse and/or refractory
  • A Karnofsky Performance Status (KPS) of greater than or equal to 60.
  • If female of childbearing potential, patients must have a negative serum or urine pregnancy test within 7 days of study enrollment. Men and women with reproductive potential must use as an effective contraceptive method while enrolled in the study. Patients must have contraceptive and/or fertility counseling prior to entering the study, i.e., information on sperm banking, etc.
  • Signed, written informed consent.
  • Ability to comply with study procedures and follow-up examinations.
  • Adequate organ function as indicated by specific laboratory values (defined in the protocol), obtained within two weeks prior to registration.
  • Classified as AML FAB M3 (Acute Promyelocytic leukemia) and have been treated with at least 2 regimens (a retinoic acid containing regimen and an arsenic trioxide containing regimen) before being considered for this study.
  • Received previous treatment with CLOFARABINE.
  • Received more than two previous induction regimens or cycles for the treatment of AML.
  • Relapsed \> 1 year.
  • Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
  • Are pregnant or lactating.
  • Have psychiatric disorders that would interfere with consent, study participation or follow-up.
  • Are receiving any other chemotherapy or corticosteroids. Patients must be off previous therapy for at least two weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Washington D.C., District of Columbia, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Buffalo, New York, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Norfolk, Virginia, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

ClofarabineDosage Forms

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Adenine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesNucleotidesRibonucleotidesPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 6, 2002

First Posted

September 9, 2002

Study Start

May 1, 2002

Study Completion

March 1, 2003

Last Updated

March 19, 2014

Record last verified: 2014-03

Locations

US(12)