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

Sponsor
BioCryst Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00640523
Collaborator
(none)
23
Enrollment
11
Locations
44
Duration (Months)
2.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the effectiveness and safety of forodesine in CLL patients

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
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 :
Mar 1, 2008
Actual Primary Completion Date :
Nov 1, 2010
Actual Study Completion Date :
Nov 1, 2011

Outcome Measures

Primary Outcome Measures

  1. Overall response rate [Up to 6 cycles of therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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.

  5. age >65 years

  6. Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3, or 4

  7. Inability to tolerate standard cytotoxic chemotherapy in the opinion of the treating physician.

  8. 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).

  9. 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.

  10. 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

Locations

Site City State Country Postal Code
1 Tower Cancer Research Foundation Beverly Hills California United States 90211
2 UCLA Medical Center Los Angeles California United States 90095
3 Indiana University Cancer Pavillion Indianapolis Indiana United States 46202
4 Center for Cancer & Blood Disorders, PC Bethesda Maryland United States 20817
5 Washington University School of Medicine St. Louis Missouri United States 63110
6 Roswell Park Cancer Institute Buffalo New York United States 14263
7 Weill Cornell Medical College New York New York United States 10065
8 Oregon Health & Science University Portland Oregon United States 97239
9 Royal Brisbane and Women's Hospital Brisbane Queensland Australia 4029
10 Frankston Hospital Frankston Victoria Australia 3199
11 Cabrini Hospital Malvern Victoria Australia 3144

Sponsors and Collaborators

  • BioCryst Pharmaceuticals

Investigators

  • Principal Investigator: Asher Chanan-Khan, MD, Roswell Park Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00640523
Other Study ID Numbers:
  • BCX1777-210
First Posted:
Mar 21, 2008
Last Update Posted:
Jan 23, 2012
Last Verified:
Jan 1, 2012
Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Jan 23, 2012