Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03207555
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    420 mg by mouth once daily.

Study Details

The standard approach to managing chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) is to wait until you have symptoms before treatment is given. The goal of this clinical research study is to learn if providing earlier treatment for CLL or SLL with ibrutinib in patients who do not have symptoms will be more effective than waiting until symptoms develop. This is an investigational study. Ibrutinib is FDA approved and commercially available for the treatment of patients with CLL or SLL. It is considered investigational to give ibrutinib to CLL and SLL patients before symptoms develop. The study doctor can describe how the study drug is designed to work. Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.

Key Dates

Start date
May 23, 2018
Status verified
Aug 2025
Primary completion
Aug 2, 2024
Completion
Aug 2, 2024

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib
    Participants take Ibrutinib by mouth 1 time every day for up to 2 years (24 cycles).

Primary Outcome Measure

Participants With Complete Remission (CR) at 24 Months [ Time Frame: Up to 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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