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Phase II Study to Evaluate the Tolerability and Efficacy of Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients With Hydroxychloroquine.


Phase 2
18 Years
N/A
Not Enrolling
Both
B-Cell Chronic Lymphocytic Leukemia

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Trial Information

Phase II Study to Evaluate the Tolerability and Efficacy of Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients With Hydroxychloroquine.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Stabilization or decrease in measurable disease by CBC and/or physical exam

Outcome Time Frame:

1 yr

Safety Issue:

No

Principal Investigator

Kanti R Rai, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NSLIJ

Authority:

United States: Institutional Review Board

Study ID:

08-088

NCT ID:

NCT00771056

Start Date:

July 2008

Completion Date:

January 2012

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia
  • untreated
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

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