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Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT00289549
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : February 8, 2012
Sponsor:
Information provided by (Responsible Party):
BioCryst Pharmaceuticals

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).

Condition or disease Intervention/treatment Phase
Leukemia, Lymphocytic, Chronic Drug: forodesine hydrochloride (BCX-1777) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-Refractory Chronic Lymphocytic Leukemia (CLL)
Study Start Date : June 2005
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009



Intervention Details:
  • Drug: forodesine hydrochloride (BCX-1777)
    experimental, forodesine oral dose 200 mg administered daily.


Primary Outcome Measures :
  1. Response rate after 2 cyclesof forodesine therapy. [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289549


Locations
United States, Texas
MD Anderson Cancer Center, University of Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
BioCryst Pharmaceuticals
Investigators
Principal Investigator: Farhad Ravandi, MD MD Anderson Cancer Center, University of Texas

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00289549     History of Changes
Other Study ID Numbers: BCX1777-Bo-05-204
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: February 2012

Keywords provided by BioCryst Pharmaceuticals:
CLL
Chronic lymphocytic leukemia
leukemia
Advanced, fludarabine-refractory CLL

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Fludarabine
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs