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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00640523
Recruitment Status : Completed
First Posted : March 21, 2008
Last Update Posted : January 23, 2012
Information provided by (Responsible Party):
BioCryst Pharmaceuticals

Brief Summary:
To evaluate the effectiveness and safety of forodesine in CLL patients

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia (CLL) Drug: forodesine HCl Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Forodesine in Subjects With Chronic Lymphocytic Leukemia (CLL)
Study Start Date : March 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: forodesine HCl
    2 x 100mg capsules daily

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: Up to 6 cycles of therapy ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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.

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 identifier (NCT number): NCT00640523

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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
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Principal Investigator: Asher Chanan-Khan, MD Roswell Park Cancer Institute
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Responsible Party: BioCryst Pharmaceuticals Identifier: NCT00640523    
Other Study ID Numbers: BCX1777-210
First Posted: March 21, 2008    Key Record Dates
Last Update Posted: January 23, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell