Hydroxychloroquine in Untreated B-CLL Patients

NCT00771056 | Terminated Phase 2 Results

• 1 other identifier: 08-088
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

B-Cell Chronic Lymphocytic Leukemia

Keywords

untreated

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Response

  Percentage of participants with a reduction of the absolute lymphocytic count- ALC

  1 yr

Secondary Outcomes (1)

• Time to Next Treatment

  1 yr

Study Arms (1)

Hydroxychloroquine

EXPERIMENTAL

Hydroxychloroquine 400 mg po daily for up to one year.

Drug: Hydroxychloroquine

Interventions

Hydroxychloroquine DRUG

400mg by mouth daily x 1 year

Also known as: Plaquenil

Hydroxychloroquine

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Long Island Jewish Medical Center CLL Research and Treatment Center

New Hyde Park, New York, 11040, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; 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

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Kanti R Rai, MD
• Organization: Northwell Health (formerly North Shore LIJ Health System)

krai@nshs.edu

(718)470-4050

Study Officials

• Kanti R Rai, MD

  NSLIJ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 10, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: August 22, 2016
• Results First Posted: July 26, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)