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Phase II Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-Refractory Chronic Lymphocytic Leukemia (CLL)


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphocytic, Chronic

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Trial Information

Phase II Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-Refractory Chronic Lymphocytic Leukemia (CLL)


Inclusion Criteria:



- Ages 18 years and older

- Diagnosis of CLL established by peripheral blood and bone marrow examination and
using the standard criteria

- Patients with Rai stage III or IV, or earlier stage with massive, symptomatic
lymphadenopathy requiring therapy

- Primary resistance to fludarabine-based therapy (no complete response [CR] or partial
response [PR]) or progressive disease within 6 months of response to prior
fludarabine containing regimen.

- ECOG performance status of 0, 1, 2 or 3

- Willing to take adequate contraception (i.e. latex condom, cervical cap, diaphragm,
abstinence, etc.) for the entire duration of the study and 3 months after

- All investigational treatments should have been discontinued for at least 1 week
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 4

- Inadequate renal function: creatinine 2.0 or more unless related to the disease

- Inadequate liver function: bilirubin 3.0 or more, transaminases 3 x upper limit of
normal or more unless related to the disease

- Known positive test for HIV

- Patients with known hepatitis B and/or hepatitis C active infection

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate after 2 cyclesof forodesine therapy.

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Farhad Ravandi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

MD Anderson Cancer Center, University of Texas

Authority:

United States: Food and Drug Administration

Study ID:

BCX1777-Bo-05-204

NCT ID:

NCT00289549

Start Date:

June 2005

Completion Date:

January 2009

Related Keywords:

  • Leukemia, Lymphocytic, Chronic
  • CLL
  • Chronic lymphocytic leukemia
  • leukemia
  • Advanced, fludarabine-refractory CLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

MD Anderson Cancer Center, University of TexasHouston, Texas  77030