NCT00640523

Brief Summary

To evaluate the effectiveness and safety of forodesine in CLL patients

Trial Health

90
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2008

Typical duration for phase_2

Geographic Reach
2 countries

11 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

March 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

January 23, 2012

Status Verified

January 1, 2012

Enrollment Period

2.7 years

First QC Date

March 17, 2008

Last Update Submit

January 18, 2012

Conditions

Chronic Lymphocytic Leukemia (CLL)

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    Up to 6 cycles of therapy

Interventions

forodesine HClDRUG

2 x 100mg capsules daily

Eligibility Criteria

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

You may qualify if:

  • Age 18 years and older
  • Diagnosis of CLL established by peripheral blood and/or bone marrow examination and using the standard diagnostic criteria.
  • Subjects with Rai stage III or IV, or earlier stage requiring therapy as determined by the 1996 National Cancer Institute -Working Group (NCI-WG) criterion
  • Primary resistant (no CR or PR) or progressive disease after response to at least one prior treatment regimen OR treatment naïve subjects who meet at least one of the following criteria.
  • age \>65 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3, or 4
  • Inability to tolerate standard cytotoxic chemotherapy in the opinion of the treating physician.
  • ECOG performance status of 0, 1, or 2 (for subjects with primary resistance or progressive disease after response to at least one prior treatment regimen).
  • Willing to take adequate contraceptive measures (i.e., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after, except for patients who are post menopausal or have prior hysterectomy.
  • All investigational treatments should have been discontinued for at least 3 weeks prior to the initiation of the study drug.

You may not qualify if:

  • Pregnant or nursing.
  • Unable or unwilling to sign consent.
  • Severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy.
  • Active serious infections that are not controlled by antibiotics.
  • ECOG performance status \>2 (except for treatment naïve subjects where ECOG performance status 0, 1 or 5 is excluded).
  • Inadequate renal function: creatinine \> or equal to 2.0 unless related to the disease.
  • Inadequate liver function: bilirubin \> or equal to 3.0; transaminases \> or equal to 3.0 times the upper limit of normal unless related to the disease.
  • Known positive test for human immunodeficiency virus (HIV).
  • Subjects with known hepatitis B and/or hepatitis C active infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Tower Cancer Research Foundation

Beverly Hills, California, 90211, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Indiana University Cancer Pavillion

Indianapolis, Indiana, 46202, United States

Location

Center for Cancer & Blood Disorders, PC

Bethesda, Maryland, 20817, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

Cabrini Hospital

Malvern, Victoria, 3144, Australia

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Asher Chanan-Khan, MD

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 21, 2008

Study Start

March 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2011

Last Updated

January 23, 2012

Record last verified: 2012-01

Locations

AU(3)US(8)