TerminatedNCT00771056Updated Aug 22, 2016Results posted

Hydroxychloroquine in Untreated B-CLL Patients

A Phase 2 interventional study of Hydroxychloroquine in B-Cell Chronic Lymphocytic Leukemia, sponsored by Northwell Health. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-22.

Sponsored by Northwell Health · Phase 2, Interventional, and Treatment

Why this study was terminated

study suspended while data is reviewed for safety and efficacy.

Phase: Phase 2
Study type: Interventional
Enrollment: 23
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Read the detailed description

This is a single-center, open-label, single arm Phase 2 study evaluating the feasibility, and efficacy of treating CLL subjects with hydroxychloroquine. The study schema and schedule of events are as follows:

Prior to beginning hydroxychloroquine:

Blood samples to be taken.
Baseline tests confirming diagnosis of CLL as defined above (if not already obtained in records)
Physical exam performed
Either six months prior or 4 weeks within starting HCQ ophthalmologic exam documented
Days 1-365 subject takes hydroxychloroquine 400mg/day
At 2 weeks: CBC and chemistry
Every 4 weeks: CBC, chemistry, history (including the inquiry about the presence or absence of visual symptoms) and physical exam.
Starting at 4 weeks: blood samples taken for laboratory companion studies taken at office visit every 8 weeks.
At 6 months (+ or - 30 days): subject will have follow up ophthalmologic exam). This will also be done in the presence of any visual/ocular symptoms.

All subjects must meet the selection criteria for registration in this study. All subjects must have a peripheral blood sample submitted. It is estimated that approximately 70 subjects will be screened. The anticipated accrual period is 12 months.

Conditions studied

B-Cell Chronic Lymphocytic Leukemia

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Keywords

untreated

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 23 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.

Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

Exclusion Criteria:

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 23 participants (actual)

Study arms

Experimental
Hydroxychloroquine
Hydroxychloroquine 400 mg po daily for up to one year.
Drug: Hydroxychloroquine

Interventions

DrugHydroxychloroquine
400mg by mouth daily x 1 year
Also known as: Plaquenil

What researchers measure

Primary outcomes

Percentage of Participants With Response
Percentage of participants with a reduction of the absolute lymphocytic count- ALC
Time frame: 1 yr

Secondary outcomes

Time to Next Treatment
number of months to time from last HCQ dose to next CLL treatment
Time frame: 1 yr

Results

Posted Jul 26, 2016

Participant flow

Recruitment was from April 2009 through termination December 2011. Patients were identified and enrolled in the CLL Research and Treatment Program where they already were being seen for care of their CLL.

Participant flow — Overall Study
Milestone	Hydroxychloroquine
Started	23
Completed	18
Not completed	5

Outcome measures

PrimaryPercentage of Participants With Response

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

Time frame:: 1 yr
Reported as:: Number · percentage of participants

Percentage of Participants With Response
percentage of participants	Hydroxychloroquine
Percentage of Participants With Response	54.4

SecondaryTime to Next Treatment

number of months to time from last HCQ dose to next CLL treatment

Time frame:: 1 yr
Reported as:: Mean · months

Time to Next Treatment
months	Hydroxychloroquine
Time to Next Treatment	4.3 (2 to 7)

Adverse events

Collected over Adverse event reporting wil be reported if applicable as subjects are monitored on a monthly basis.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Hydroxychloroquine	—	0/23 (0%)	0/23 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Hydroxychloroquine
<=18 years	0
Between 18 and 65 years	16
>=65 years	7

Age, Continuous
Age, Continuous(years)	Hydroxychloroquine
Mean	59 (44 to 77)

Sex: Female, Male
Sex: Female, Male(Participants)	Hydroxychloroquine
Female	6
Male	17

Region of Enrollment
Region of Enrollment(participants)	Hydroxychloroquine
United States	23

Study locations

1 site

Long Island Jewish Medical Center CLL Research and Treatment Center
New Hyde Park, New York 11040, United States

References and documents

Individual participant data

Plan to share: No — There is no plan to contact each individual patient (participant in the trial) and inform hem/her of results of this trial as it affects each one of them.

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00771056
Lead sponsor: Northwell Health
Responsible party: Kanti Rai, MD (Principal Investigator, Northwell Health) — Principal investigator
First posted: Oct 10, 2008
Start date: Jul 2008
Primary completion: Jan 2012
Completion: Jan 2012
Results posted: Jul 26, 2016
Last update: Aug 22, 2016

Study contacts

Kanti R Rai, MD

principal investigator · NSLIJ

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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