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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00289549
First received: February 8, 2006
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Leukemia, Lymphocytic, Chronic
Drug: forodesine hydrochloride (BCX-1777)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-Refractory Chronic Lymphocytic Leukemia (CLL)

Resource links provided by NLM:


Further study details as provided by BioCryst Pharmaceuticals:

Primary Outcome Measures:
  • Response rate after 2 cyclesof forodesine therapy. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: June 2005
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: forodesine hydrochloride (BCX-1777)
    experimental, forodesine oral dose 200 mg administered daily.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by BioCryst Pharmaceuticals

Additional 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
Study First Received: February 8, 2006
Last Updated: February 6, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 28, 2014