NCT00081887

Brief Summary

Primary Objectives:

  1. 1.To determine the maximum tolerated dose (MTD) of clofarabine in Chronic Lymphocytic Leukemia (CLL).
  2. 2.To determine the toxicity profile of clofarabine in CLL.
  3. 3.To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile of clofarabine in CLL.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

April 23, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2004

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

3 years

First QC Date

April 23, 2004

Last Update Submit

July 31, 2012

Conditions

Chronic Lymphocytic LeukemiaLeukemia

Keywords

Chronic Lymphocytic LeukemiaCLLLeukemiaClofarabineClofarexClolar

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose (MTD)

    Following each 4 week treatment cycle

Study Arms (1)

Weekly Clofarabine

EXPERIMENTAL
Drug: Clofarabine

Interventions

ClofarabineDRUG

Starting dose is 10 mg/m\^2 as a 1-hour infusion into a vein once every 2 weeks for 4 weeks (1 cycle).

Also known as: Clofarex, Clolar
Weekly Clofarabine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic lymphocytic leukemia (CLL), CLL/PLL (as defined by FAB), and PLL (B- and T-cell phenotypes) who have relapsed from or are refractory to at least one fludarabine-based regimen.
  • Absolute neutrophil count (ANC) \>= 1 x 10(9)/L and platelet count \>= 50 x 10(9)/L
  • Adequate liver function (total bilirubin \<= 1.5 x ULN, SGPT \<= 2.5 x ULN) and renal function (serum creatine \<= 1.5 x ULN).
  • ECOG performance status \<= 2.

You may not qualify if:

  • Patients with NYHA \>= grade 3 heart disease as assessed by history and/or physical examination
  • Pregnant or breastfeeding women or patients who are unwilling or unable to practice adequate contraception.
  • Chemotherapy within 4 weeks of starting therapy, or concurrent anticancer therapy (chemotherapy, radiotherapy, or biologic therapy)
  • Other malignancy within 3 years except in situ carcinoma
  • Unwilling or unable to provide informed consent
  • Hypersensitivity to nucleoside analogues
  • Other significant medical condition that compromises safety, compliance or study conduct, including but not limited to uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within 6 months, ventricular arrhythmia, diabetes, active infection, pulmonary fibrosis, and chronic hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLeukemia

Interventions

Clofarabine

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic 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

  • Stefan Faderl, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2004

First Posted

April 27, 2004

Study Start

May 1, 2004

Primary Completion

May 1, 2007

Study Completion

June 1, 2007

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

US(1)