- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00646165
Trial of Forodesine in Patients With Relapsed B-cell Chronic Lymphocytic Leukemia
March 30, 2010 updated by: Mundipharma Research Limited
Phase 1, Multicentre, Open-label, Dose Finding Trial of Forodesine in Patients With Relapsed B-cell Chronic Lymphocytic Leukemia
To determine the dose and duration of treatment for the best overall response with Forodesine in relapsed B-cell chronic lymphocytic leukemia
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 best achievable response with Forodesine as a single drug treatment.
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Barcelona, Spain, 08036
- H. Clinic i Provincial
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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)
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Secondary Outcome Measures
Outcome Measure |
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Assess safety & tolerability of forodesine in B-CLL in vitro sensitivity to forodesine & drug combinations including forodesine of peripheral lymphocytes of patients enrolled in study & to correlate these in vitro findings with clinical response
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
March 26, 2008
First Submitted That Met QC Criteria
March 27, 2008
First Posted (Estimate)
March 28, 2008
Study Record Updates
Last Update Posted (Estimate)
March 31, 2010
Last Update Submitted That Met QC Criteria
March 30, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCX1777-110
- 2007-000256-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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