Actively Recruiting
A Pilot Study on Intermittent and Repeated Dosing of Ibrutinib in the Treatment of Patients With Advanced-phase Chronic Lymphocytic Leukemia (CLL)
Led by Jeanette Lundin · Updated on 2021-02-25
50
Participants Needed
9
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an intermittent dosing approach of ibrutinib, a drug used to treat advanced-phase chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The study explores whether stopping and restarting ibrutinib based on disease progression can maintain disease control while potentially reducing drug costs and side effects. This pilot study focuses on patients who have already received at least six months of ibrutinib and achieved a stable partial remission. Participants will follow an "ON-OFF" dosing schedule where ibrutinib is stopped after stable partial response and restarted upon clinical progression. The drug is given at the standard daily oral dose of 420 mg during ON periods, and cycles of treatment and off-therapy periods may be repeated until resistance, intolerance, or the need for continuous dosing arises. This approach is being tested to assess the feasibility of intermittent therapy. Throughout the study, participants will be monitored for safety by tracking adverse events over 1 to 24 months. Researchers will also evaluate response rates, time to partial remission, duration off therapy before restarting ibrutinib, cumulative dose, survival, risk of early disease rebound, and time until alternative treatments are needed. Participants will have regular visits for clinical assessments, laboratory tests, and adherence to the study schedule.
CONDITIONS
Brief Title
A Pilot Study on Intermittent Ibrutinib in Patients With Advanced-phase Chronic Lymphocytic Leukemia (CLL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily provide written informed consent
- Age 18 years or older with no upper age limit
- Able to follow study visits and requirements
- Diagnosed with CLL/SLL and active disease needing treatment after failed chemoimmunotherapy or with specific genetic markers
- Received at least 6 months of ibrutinib therapy and achieved at least partial remission
- ECOG performance status of 2 or less
- Laboratory tests showing adequate neutrophil and platelet counts, normal kidney function, and acceptable liver enzyme levels
- Disease free of prior malignancies for at least 2 years except certain skin or cervical/breast cancers
- Agree to use reliable contraception unless post-menopausal or surgically sterilized
You will not qualify if you...
- Serious medical, laboratory, or psychiatric conditions preventing informed consent
- Pregnant or breastfeeding females
- Any condition placing the subject at unacceptable risk or interfering with data interpretation
- Use of other experimental therapies within 14 days
- Concurrent use of other anti-cancer treatments besides low-dose corticosteroids
- Positive for HIV or infectious hepatitis A, B, or C
- Opportunistic infections within last 3 months
- Planned for or candidate for allogeneic stem cell transplant
- Uncontrolled hemolytic anemia or autoimmune thrombocytopenia
- CNS involvement or history of Richter's transformation
- Anticoagulation treatment with warfarin or similar within 28 days
- Treatment with strong CYP3A4/5 inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive intermittent treatment with ibrutinib. They start with an OFF therapy period, followed by restarting ibrutinib at clinical progression. This cycle of ON and OFF therapy periods repeats based on individual response.
Visits occur as needed based on clinical progress and treatment cycles
Trial Site Locations
Total: 9 locations
1
St Olavs Hospital
Trondheim, Norway, 7030
Actively Recruiting
2
Falu lasarett
Falun, Dalarna County, Sweden, 791 82
Actively Recruiting
3
Gävle Hospital
Gävle, Gävleborg County, Sweden, 801 87
Actively Recruiting
4
Skåne University Hospital
Lund, Skåne County, Sweden, 222 42
Not Yet Recruiting
5
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Not Yet Recruiting
6
Örebro University Hospital
Örebro, Sweden, 701 85
Actively Recruiting
7
Karolinska University Hospital
Stockholm, Sweden, 17176
Actively Recruiting
8
Norrland's University Hospital
Umeå, Sweden, 901 85
Not Yet Recruiting
9
Akademiska hospital
Uppsala, Sweden, 751 85
Actively Recruiting
Research Team
J
Jeanette Lundin, MD PhD
S
Sanna Nyström, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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