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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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B-cell Chronic Lymphocytic Leukemia

Keywords

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Leukemia, CLL

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Forodesine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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H. Clinic I Provincial

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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2007-000256-14

Identifier Type: -

Identifier Source: secondary_id

BCX1777-110