Hydroxychloroquine in Untreated B-CLL Patients

This study is currently recruiting participants.

Verified by North Shore Long Island Jewish Health System, April 2009

First Received: October 8, 2008 Last Updated: April 22, 2009 History of Changes

Sponsored by:	North Shore Long Island Jewish Health System
Information provided by:	North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT00771056

Purpose

Eligible CLL patients who sign an informed consent will be started on hydroxychloroquine 400mg po daily for up to one year. They will be monitored for disease status as well as adverse reactions after two weeks and then every 4 weeks. Ophthalmologic exams is required at baseline and every 6 months or sooner if the patient develops any visual disturbances.

Condition	Intervention	Phase
B-Cell Chronic Lymphocytic Leukemia	Drug: Hydroxychloroquine	Phase II

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

Drug Information available for: Hydroxychloroquine Hydroxychloroquine sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study to Evaluate the Tolerability and Efficacy of Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients With Hydroxychloroquine.

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:

Stabilization or decrease in measurable disease by CBC and/or physical exam [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to next treatment [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Estimated Enrollment:	33
Study Start Date:	July 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Intervention Details:

400mg by mouth daily x 1 year

Eligibility

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

Criteria

Inclusion Criteria:

Flow cytometry confirmed B-CLL
No prior chemotherapy or immunotherapy
Performance status 0-2
Age > 18 years old
If childbearing age, woman you must be willing to use birth control for length of hydroxychloroquine use
Must have capacity to consent for study and sign consent form
Asymptomatic CLL not requiring treatment at time of study entry

Exclusion Criteria:

Pregnancy
Significant optic nerve pathology as documented by an opthalmologic exam
Hypersensitivity to 4-aminoquinoline compound
Patients taking cardiac glycosides and cyclosporine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771056

Contacts

Contact: Angelica Caramanica, PA	718-470-4050	acaraman@.nshs.edu
Contact: Peter Garofalo, RN	718-470-4050	pgarofalo@lij.edu

Locations

United States, New York
Long Island Jewish Medical Center CLL Research and Treatment Center	Recruiting
New Hyde Park, New York, United States, 11040
Contact: Angelica Caramanica, PA 718-470-4050 acaraman@nshs.edu
Contact: Peter Garofalo, RN 718-470-4050 pgarofalo@lij.edu
Principal Investigator: Matthew Kaufman, MD

Sponsors and Collaborators

North Shore Long Island Jewish Health System

Investigators

Principal Investigator:

Matthew Kaufman, MD

NSLIJ

More Information

No publications provided

Responsible Party:	NSLIJ ( Matthew Kaufman M.D )
Study ID Numbers:	08-088
Study First Received:	October 8, 2008
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00771056 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:

untreated

Study placed in the following topic categories:

Antimalarials
Lymphatic Diseases
Leukemia
Chronic Lymphocytic Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders

Leukemia, Lymphocytic, Chronic, B-Cell
Hydroxychloroquine
Antirheumatic Agents
Leukemia, B-cell, Chronic
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Leukemia, Lymphoid
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Antimalarials

Leukemia
Lymphatic Diseases
Antiparasitic Agents
Neoplasms
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Hydroxychloroquine
Antirheumatic Agents
Leukemia, B-Cell
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on May 06, 2009