Clinical trial · Interventional
Hydroxychloroquine in Untreated B-CLL Patients
Phase II Study to Evaluate the Tolerability and Efficacy of Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients With Hydroxychloroquine.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): study suspended while data is reviewed for safety and efficacy.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-Cell Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydroxychloroquine | Drug | Hydroxychloroquine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hydroxychloroquine
- description
- Hydroxychloroquine 400 mg po daily for up to one year.
- interventionNames
- Drug: Hydroxychloroquine
Primary outcomes (1)
- measure
- Percentage of Participants With Response
- timeFrame
- 1 yr
- description
- Percentage of participants with a reduction of the absolute lymphocytic count- ALC
Secondary outcomes (1)
- measure
- Time to Next Treatment
- timeFrame
- 1 yr
- description
- number of months to time from last HCQ dose to next CLL treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available