Status:
TERMINATED
Trial of Forodesine in Patients With Relapsed B-cell Chronic Lymphocytic Leukemia
Lead Sponsor:
Mundipharma Research Limited
Conditions:
B-cell Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine the dose and duration of treatment for the best overall response with Forodesine in relapsed B-cell chronic lymphocytic leukemia
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00646165
Start Date
July 1 2008
End Date
May 1 2009
Last Update
March 31 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
H. Clinic I Provincial
Barcelona, Spain, 08036