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Phase 1, Multicentre, Open-label, Dose Finding Trial of Forodesine in Patients With Relapsed B-cell Chronic Lymphocytic Leukemia

Phase 1
18 Years
Not Enrolling
B-cell Chronic Lymphocytic Leukemia

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Trial Information

Phase 1, Multicentre, Open-label, Dose Finding Trial of Forodesine in Patients With Relapsed B-cell Chronic Lymphocytic Leukemia

An open label, multi centre, three arm, dose finding Phase 1 trial with Forodesine as a
single drug treatment in patients with relapsed CLL to establish dose and duration of
treatment resulting in the best achievable response with Forodesine as a single drug

Inclusion Criteria:

- Patients with confirmed Binet Stage B or C B-CLL as defined by the National Cancer
Institute (NCI) sponsored working group who have received up to 2 previous lines of
treatment, one of which was fludarabine based. The two previous treatments could
have included combination therapies.

- Patients must be ≥18 years of age, have a life expectancy of >6 months, and an
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. -
Female patients must not be pregnant (as confirmed by negative pregnancy test for
women of childbearing potential) and female and male patients must be willing to use
effective contraception for the entire duration of treatment and 2 months thereafter.

Exclusion Criteria:

- Patients who have received more than 2 previous lines of treatment will be excluded
from this study.

- Additional groups of patients who may not participate in the study include: patients
who are pregnant and/or nursing; patients on corticosteroid treatment; patients with
active infection (bacterial, viral or fungal) or severe infection (WHO 4th degree)
within the last 3 months; patients with total bilirubin > 2 × ULN; patients with
calculated creatinine clearance <70 mL/min; patients with seropositivity for human
immunodeficiency virus, hepatitis B virus, or hepatitis C virus; patients with any
coexisting medical or psychological condition that would preclude participation in
the required study procedures; patients who have participated in another clinical
study <6 weeks prior to this study; or patients with a known hypersensitivity to the
study medication.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the dose and duration of treatment for the best achievable overall response and partial responders with forodesine in relapsed B-cell chronic lymphocytic leukemia (B-Cll)


Spain: Ethics Committee

Study ID:




Start Date:

July 2008

Completion Date:

May 2009

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia
  • Leukemia, CLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid