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

B-cell Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00646165
• Other study ID #: BCX1777-110
• Secondary ID: 2007-000256-14
• Status: Terminated
• Phase: Phase 1
• First received: March 26, 2008
• Last updated: March 30, 2010
• Start date: July 2008
• Est. completion date: May 2009

Study information

• Verified date: March 2010
• Source: Mundipharma Research Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Forodesine

Locations

Country	Name	City	State
Spain	H. Clinic I Provincial	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Research Limited

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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