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Trial of Forodesine in Patients With Relapsed B-cell Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00646165
Recruitment Status : Terminated (Poor recruitment and change in development strategy)
First Posted : March 28, 2008
Last Update Posted : March 31, 2010
Information provided by:

Study Description
Brief Summary:
To determine the dose and duration of treatment for the best overall response with Forodesine in relapsed B-cell chronic lymphocytic leukemia

Condition or disease Intervention/treatment Phase
B-cell Chronic Lymphocytic Leukemia Drug: Forodesine Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1, Multicentre, Open-label, Dose Finding Trial of Forodesine in Patients With Relapsed B-cell Chronic Lymphocytic Leukemia
Study Start Date : July 2008
Primary Completion Date : January 2009
Study Completion Date : May 2009

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646165

H. Clinic I Provincial
Barcelona, Spain, 08036
Sponsors and Collaborators
Mundipharma Research Limited
More Information

ClinicalTrials.gov Identifier: NCT00646165     History of Changes
Other Study ID Numbers: BCX1777-110
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: March 31, 2010
Last Verified: March 2010

Keywords provided by Mundipharma Research Limited:
Leukemia, CLL

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell