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

NCT00646165 | Terminated Phase 1

• 2 other identifiers: BCX1777-1102007-000256-14
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

B-cell Chronic Lymphocytic Leukemia

Keywords

Leukemia, CLL

Outcome Measures

Primary Outcomes (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 Outcomes (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

Interventions

Forodesine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mundipharma Research Limited: lead

Study Sites (1)

H. Clinic I Provincial

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia

Interventions

forodesine

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: March 28, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 31, 2010

Record last verified: 2010-03

Locations

ES (1)