Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-Refractory Chronic Lymphocytic Leukemia (CLL)

This study is ongoing, but not recruiting participants.

First Received: February 8, 2006 Last Updated: August 4, 2008 History of Changes

Sponsored by:	BioCryst Pharmaceuticals
Information provided by:	BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00289549

Purpose

Forodesine hydrochloride will be administered orally at a dose of 200 mg daily for 7 days each week for 4 weeks (cycle number 1). The drug will be administered once daily one hour prior to or two hours after meals. Patients will be evaluated after 1 full cycle of therapy (28 days).

Condition	Intervention	Phase
Leukemia, Lymphocytic, Chronic	Drug: forodesine hydrochloride (BCX-1777)	Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Fludarabine Fludarabine monophosphate Forodesine Forodesine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-Refractory Chronic Lymphocytic Leukemia (CLL)

Further study details as provided by BioCryst Pharmaceuticals:

Estimated Enrollment:	30
Study Start Date:	June 2005
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ages 18 years and older
Diagnosis of CLL established by peripheral blood and bone marrow examination and using the standard criteria
Patients with Rai stage III or IV, or earlier stage with massive, symptomatic lymphadenopathy requiring therapy
Primary resistance to fludarabine-based therapy (no complete response [CR] or partial response [PR]) or progressive disease within 6 months of response to prior fludarabine containing regimen.
ECOG performance status of 0, 1, 2 or 3
Willing to take adequate contraception (i.e. latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after
All investigational treatments should have been discontinued for at least 1 week prior to the initiation of the study drug.

Exclusion Criteria:

Pregnant or nursing
Unable or unwilling to sign consent
Severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy
Active serious infections that are not controlled by antibiotics
ECOG performance status 4
Inadequate renal function: creatinine 2.0 or more unless related to the disease
Inadequate liver function: bilirubin 3.0 or more, transaminases 3 x upper limit of normal or more unless related to the disease
Known positive test for HIV
Patients with known hepatitis B and/or hepatitis C active infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289549

Locations

United States, Texas
MD Anderson Cancer Center, University of Texas
Houston, Texas, United States, 77030

Sponsors and Collaborators

BioCryst Pharmaceuticals

Investigators

Principal Investigator:

Farhad Ravandi, MD

MD Anderson Cancer Center, University of Texas

More Information

No publications provided

Responsible Party:	BioCryst Pharmaceuticals, Inc. ( W. James Alexander, M.D., M.P.H/ Snr VP Clinical & Regulatory Operations, CMO )
Study ID Numbers:	BCX1777-Bo-05-204
Study First Received:	February 8, 2006
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00289549 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by BioCryst Pharmaceuticals:

CLL
Chronic lymphocytic leukemia
leukemia
Advanced, fludarabine-refractory CLL

Study placed in the following topic categories:

Antimetabolites
Leukemia, Lymphoid
Immunoproliferative Disorders
Immunologic Factors
Fludarabine monophosphate
Immunosuppressive Agents
Leukemia

Lymphatic Diseases
Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Fludarabine
Leukemia, B-Cell
Lymphoproliferative Disorders
Leukemia, B-cell, Chronic

Additional relevant MeSH terms:

Antimetabolites
Leukemia, Lymphoid
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Fludarabine monophosphate

Immunosuppressive Agents
Pharmacologic Actions
Leukemia
Lymphatic Diseases
Neoplasms
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Fludarabine
Leukemia, B-Cell
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on May 07, 2009