Intermittent dosing of ibrutinib for advanced chronic lymphocytic leukemia
A Pilot Study on Intermittent and Repeated Dosing of Ibrutinib in the Treatment of Patients With Advanced-phase Chronic Lymphocytic Leukemia (CLL)
This study is testing if taking the cancer drug ibrutinib in a 'ON-OFF' way can help people with advanced chronic lymphocytic leukemia stay healthy while possibly having fewer side effects and lower costs.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Drugs / interventions | ibrutinib, prednisone |
| Locations | 9 sites (Trondheim and 8 other locations) |
| Trial ID | NCT04771507 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of intermittent dosing of ibrutinib, a drug used to treat advanced-phase chronic lymphocytic leukemia (CLL), in patients who have previously received continuous treatment. The study aims to determine if an 'ON-OFF' dosing strategy can maintain disease control while potentially reducing side effects and costs associated with long-term therapy. Participants will be monitored for their response to this alternative dosing approach until they require other treatments due to resistance or intolerance. The study focuses on patients who have shown clinical improvement after at least six months of continuous ibrutinib therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with active CLL who have previously failed chemoimmunotherapy and have shown clinical improvement on ibrutinib.
Not a fit: Patients who have not received prior treatment with ibrutinib or those with early-stage CLL may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more cost-effective and tolerable treatment option for patients with CLL.
How similar studies have performed: While intermittent dosing strategies are being explored, this specific approach to ibrutinib in CLL is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ability to understand and voluntarily provide written informed consent and comply with the requirements of the study. 2. Age 18 years and older. There is no upper age limit in this trial. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Before start ibrutinib for the first time: diagnosed with CLL/SLL and active disease in need of treatment after having failed chemoimmunotherapy for CLL defined as a) refractory according to iwCLL criteria; or b) relapsed and deemed not suitable for additional chemo- or chemoimmunotherapy or c) del 17p and/or TP53 mutation irrespective of prior therapy. 5. Having received at least 6 months of ibrutinib therapy and having achieved at least clinical PR according to IWCLL criteria. 6. ECOG performance status of \</= 2 at screening. 7. Laboratory test results: * Absolute neutrophil count \>/= 0.5 x 109/L * Platelet count \>/= 30 x 109/L * Serum creatinine \< 177 µmol/L * ASAT (SGOT) and ALAT (SGPT) \>/= 2 x ULN or \>/= 5 x ULN unless attributable to CLL/SLL 8. Disease free of prior malignancies for \>/= 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. 9. Agree to use reliable forms of contraception. Post-menopausal females and surgically sterilized females are exempt from this criterion. Exclusion Criteria: 1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 2. Pregnant or breast feeding females. 3. Any condition, including the presence of laboratory abnormalities, which according to the responsible physician places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 4. Use of any other experimental therapy within the last 14 days. 5. Concurrent use of other anti-cancer agents or treatments than ibrutinib (except a low dose of corticosteroids, max 10 mg of prednisone/day). 6. Positivity for HIV or infectious hepatitis, type A, B or C. 7. Opportunistic infections within the last 3 months. 8. Patient planned for or being a potential candidate for allo-SCT. 9. Uncontrolled hemolytic anemia or autoimmune thrombocytopenia. 10. CNS involvement or history of Richter's transformation. 11. Requires or has received anticoagulation treatment with warfarin or equivalent Vitamin K antagonists (eg, phenprocoumon) within 28 days of the first dose of ibrutinib. 12. Requires treatment with a strong cytochrome P450 (CYP) 3A4/5 inhibitor.
Where this trial is running
Trondheim and 8 other locations
- St Olavs Hospital — Trondheim, Norway (Recruiting)
- Falu lasarett — Falun, Dalarna County, Sweden (Recruiting)
- Gävle Hospital — Gävle, Gävleborg County, Sweden (Recruiting)
- Skåne University Hospital — Lund, Skåne County, Sweden (Not_yet_recruiting)
- Sahlgrenska University Hospital — Gothenburg, Sweden (Not_yet_recruiting)
- Örebro University Hospital — Örebro, Sweden (Recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
- Norrland's University Hospital — Umeå, Sweden (Not_yet_recruiting)
- Akademiska hospital — Uppsala, Sweden (Recruiting)
Study contacts
- Principal investigator: Jeanette Lundin, MD PhD — Karolinska University Hospital
- Study coordinator: Jeanette Lundin, MD PhD
- Email: jeanette.lundin@sll.se
- Phone: 0700 85 67 86
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.