B-Cell Chronic Lymphocytic LeukemiaPhase 2NCT00771056
Hydroxychloroquine in Untreated B-CLL Patients
A Phase 2 study testing Hydroxychloroquine in people with B-Cell Chronic Lymphocytic Leukemia, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Chronic Lymphocytic Leukemia
- What is being tested?
- Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Significant optic nerve pathology as documented by an opthalmologic exam
- Hypersensitivity to 4-aminoquinoline compound
- Patients taking cardiac glycosides and cyclosporine
Trial locations and contacts
1 site in 1 country.
United States1 site
Long Island Jewish Medical Center CLL Research and Treatment Center
New Hyde Park, New York, 11040
About this 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.
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
- B-Cell Chronic Lymphocytic Leukemia
- Being tested
- Hydroxychloroquine
- Keywords
- untreated
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Plaquenil
400mg by mouth daily x 1 year
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Experimental | Hydroxychloroquine 400 mg po daily for up to one year. Receives: Drug: Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Response
Percentage of participants with a reduction of the absolute lymphocytic count- ALC
Measured: 1 yr
Secondary outcomes (1)
Time to Next Treatment
number of months to time from last HCQ dose to next CLL treatment
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: study suspended while data is reviewed for safety and efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for B-Cell Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kanti Rai, MD, Northwell Health
- Investigators
- Kanti R Rai, MD, Principal investigator, NSLIJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771056
- Sponsor's protocol ID
- 08-088
- Status last verified
- Aug 2016
- First submitted
- 8 Oct 2008
- Last updated
- 22 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00771056
- Acronym / sponsor ID
- 08-088
- Conditions
- B-Cell Chronic Lymphocytic Leukemia
- Keywords
- untreated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study suspended while data is reviewed for safety and efficacy.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Oct 2008 (estimated)
- Results
- Posted 26 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Experimental | Drug: HydroxychloroquineHydroxychloroquine 400 mg po daily for up to one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy
- Significant optic nerve pathology as documented by an opthalmologic exam
- Hypersensitivity to 4-aminoquinoline compound
- Patients taking cardiac glycosides and cyclosporine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineAlso: Plaquenil400mg by mouth daily x 1 year | Drug | Hydroxychloroquine |
Primary outcome
Percentage of Participants With Response
Time frame: 1 yr
Percentage of participants with a reduction of the absolute lymphocytic count- ALC
1 secondary outcome
Time to Next Treatment
Time frame: 1 yr
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kanti R Rai, MD principal investigator
NSLIJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine in people with B-Cell Chronic Lymphocytic Leukemia, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Response (time frame: 1 yr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.