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
- Chronic Lymphocytic Leukemia
- Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic
- Small Lymphocytic Leukemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ibrutinib — DRUG420 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: IbrutinibParticipants 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | - |
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