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

Primary Purpose

Chronic Lymphocytic Leukemia (CLL)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
forodesine HCl
Sponsored by
BioCryst Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia (CLL)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tower Cancer Research Foundation
  • UCLA Medical Center
  • Indiana University Cancer Pavillion
  • Center for Cancer & Blood Disorders, PC
  • Washington University School of Medicine
  • Roswell Park Cancer Institute
  • Weill Cornell Medical College
  • Oregon Health & Science University
  • Royal Brisbane and Women's Hospital
  • Frankston Hospital
  • Cabrini Hospital

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Full Information

First Posted
March 17, 2008
Last Updated
January 18, 2012
Sponsor
BioCryst Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00640523
Brief Title
Phase II Study of Forodesine in Subjects With Chronic Lymphocytic Leukemia (CLL)
Official Title
Phase II Study of Forodesine in Subjects With Chronic Lymphocytic Leukemia (CLL)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioCryst Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia (CLL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
forodesine HCl
Intervention Description
2 x 100mg capsules daily
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
Up to 6 cycles of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years and older Diagnosis of CLL established by peripheral blood and/or bone marrow examination and using the standard diagnostic criteria. 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 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. age >65 years Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3, or 4 Inability to tolerate standard cytotoxic chemotherapy in the opinion of the treating physician. 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). 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. All investigational treatments should have been discontinued for at least 3 weeks 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 >2 (except for treatment naïve subjects where ECOG performance status 0, 1 or 5 is excluded). Inadequate renal function: creatinine > or equal to 2.0 unless related to the disease. 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. Known positive test for human immunodeficiency virus (HIV). Subjects with known hepatitis B and/or hepatitis C active infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asher Chanan-Khan, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tower Cancer Research Foundation
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Indiana University Cancer Pavillion
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Center for Cancer & Blood Disorders, PC
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Frankston Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Cabrini Hospital
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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