NCT00289549

Brief Summary

Forodesine hydrochloride will be administered orally at a dose of 200 mg daily for 7 days each week for 4 weeks (cycle number 1). The drug will be administered once daily one hour prior to or two hours after meals. Patients will be evaluated after 1 full cycle of therapy (28 days).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2005

Typical duration for phase_2

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

June 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

February 8, 2012

Status Verified

February 1, 2012

Enrollment Period

3.6 years

First QC Date

February 8, 2006

Last Update Submit

February 6, 2012

Conditions

Leukemia, Lymphocytic, Chronic

Keywords

CLLChronic lymphocytic leukemialeukemiaAdvanced, fludarabine-refractory CLL

Outcome Measures

Primary Outcomes (1)

  • Response rate after 2 cyclesof forodesine therapy.

    8 weeks

Interventions

forodesine hydrochloride (BCX-1777)DRUG

experimental, forodesine oral dose 200 mg administered daily.

Eligibility Criteria

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

You may qualify if:

  • Ages 18 years and older
  • Diagnosis of CLL established by peripheral blood and bone marrow examination and using the standard criteria
  • Patients with Rai stage III or IV, or earlier stage with massive, symptomatic lymphadenopathy requiring therapy
  • Primary resistance to fludarabine-based therapy (no complete response \[CR\] or partial response \[PR\]) or progressive disease within 6 months of response to prior fludarabine containing regimen.
  • ECOG performance status of 0, 1, 2 or 3
  • Willing to take adequate contraception (i.e. latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after
  • All investigational treatments should have been discontinued for at least 1 week 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 4
  • Inadequate renal function: creatinine 2.0 or more unless related to the disease
  • Inadequate liver function: bilirubin 3.0 or more, transaminases 3 x upper limit of normal or more unless related to the disease
  • Known positive test for HIV
  • Patients with known hepatitis B and/or hepatitis C active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center, University of Texas

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Balakrishnan K, Verma D, O'Brien S, Kilpatrick JM, Chen Y, Tyler BF, Bickel S, Bantia S, Keating MJ, Kantarjian H, Gandhi V, Ravandi F. Phase 2 and pharmacodynamic study of oral forodesine in patients with advanced, fludarabine-treated chronic lymphocytic leukemia. Blood. 2010 Aug 12;116(6):886-92. doi: 10.1182/blood-2010-02-272039. Epub 2010 Apr 28.

    PMID: 20427701DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLeukemia

Interventions

forodesine

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

Study Officials

  • Farhad Ravandi, MD

    M.D. Anderson Cancer Center

    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

February 8, 2006

First Posted

February 10, 2006

Study Start

June 1, 2005

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 8, 2012

Record last verified: 2012-02

Locations

US(1)