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Phase II Study of Forodesine in Subjects With Chronic Lymphocytic Leukemia (CLL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00640523
First received: March 17, 2008
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

To evaluate the effectiveness and safety of forodesine in CLL patients


Condition Intervention Phase
Chronic Lymphocytic Leukemia (CLL)
Drug: forodesine HCl
Phase 2

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

Resource links provided by NLM:


Further study details as provided by BioCryst Pharmaceuticals:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: Up to 6 cycles of therapy ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: March 2008
Study Completion Date: November 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: forodesine HCl
    2 x 100mg capsules daily
Detailed Description:

To investigate the efficacy (complete response [CR] + partial response [PR]) of forodesine in treating subjects with CLL who have failed at least one prior treatment regimen or who are treatment naïve but are either elderly, have poor performance status or are otherwise predicted not to tolerate cytotoxic chemotherapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years and older
  2. Diagnosis of CLL established by peripheral blood and/or bone marrow examination and using the standard diagnostic criteria.
  3. 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
  4. 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.

    1. age >65 years
    2. Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3, or 4
    3. Inability to tolerate standard cytotoxic chemotherapy in the opinion of the treating physician.
  5. 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).
  6. 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.
  7. All investigational treatments should have been discontinued for at least 3 weeks prior to the initiation of the study drug.

Exclusion Criteria:

  1. Pregnant or nursing.
  2. Unable or unwilling to sign consent.
  3. Severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy.
  4. Active serious infections that are not controlled by antibiotics.
  5. ECOG performance status >2 (except for treatment naïve subjects where ECOG performance status 0, 1 or 5 is excluded).
  6. Inadequate renal function: creatinine > or equal to 2.0 unless related to the disease.
  7. 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.
  8. Known positive test for human immunodeficiency virus (HIV).
  9. Subjects 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: NCT00640523

Locations
United States, California
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Indiana
Indiana University Cancer Pavillion
Indianapolis, Indiana, United States, 46202
United States, Maryland
Center for Cancer & Blood Disorders, PC
Bethesda, Maryland, United States, 20817
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Weill Cornell Medical College
New York, New York, United States, 10065
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Australia, Queensland
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Australia, Victoria
Frankston Hospital
Frankston, Victoria, Australia, 3199
Cabrini Hospital
Malvern, Victoria, Australia, 3144
Sponsors and Collaborators
BioCryst Pharmaceuticals
Investigators
Principal Investigator: Asher Chanan-Khan, MD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00640523     History of Changes
Other Study ID Numbers: BCX1777-210
Study First Received: March 17, 2008
Last Updated: January 18, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 27, 2014