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


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia (CLL)

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

Up to 6 cycles of therapy

Safety Issue:

No

Principal Investigator

Asher Chanan-Khan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

BCX1777-210

NCT ID:

NCT00640523

Start Date:

March 2008

Completion Date:

November 2011

Related Keywords:

  • Chronic Lymphocytic Leukemia (CLL)
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Washington University School of MedicineSaint Louis, Missouri  63110
Oregon Health & Science UniversityPortland, Oregon  97201
Tower Cancer Research FoundationBeverly Hills, California  90211
UCLA Medical CenterLos Angeles, California  90095-7059
Weill Cornell Medical CollegeNew York, New York  10021
Center for Cancer & Blood Disorders, PCBethesda, Maryland  20817
Indiana University Cancer PavillionIndianapolis, Indiana  46202