Intermittent dosing of ibrutinib for advanced chronic lymphocytic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• St Olavs Hospital
  Trondheim, Norway Recruiting
• Falu lasarett
  Falun, Dalarna County, Sweden Recruiting
• Gävle Hospital
  Gävle, Gävleborg County, Sweden Recruiting
• Örebro University Hospital
  Örebro, Sweden Recruiting
• Karolinska University Hospital
  Stockholm, Sweden 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing Nemtabrutinib to Ibrutinib or Acalabrutinib for First Line Treatment of Chronic Lymphocytic Leukemia

  This study is testing if a new drug called nemtabrutinib works as well as or better than two existing treatments for people with chronic lymphocytic leukemia who haven’t had treatment before.

  Recruiting at 181 sites Phase 3 Merck Sharp & Dohme LLC · Mobile, Alabama and 205 other locations · NCT06136559

• Using ibrutinib to treat autoimmune hemolytic anemia in patients with chronic lymphocytic leukemia

  This study is testing if the drug ibrutinib can help adults with chronic lymphocytic leukemia who also have autoimmune hemolytic anemia feel better.

  Recruiting at 3 sites Phase 2 Gruppo Italiano Malattie EMatologiche dell'Adulto · Florence and 2 other locations · NCT05694312

• Pirtobrutinib versus ibrutinib for people with CLL or SLL.

  This trial will test whether pirtobrutinib works better or is safer than ibrutinib for adults with CLL/SLL, with a separate part that tries pirtobrutinib alone in treatment‑naïve patients who have a 17p deletion.

  Recruiting at 93 sites Phase 3 Eli Lilly and Company · Anaheim, California and 142 other locations · NCT05254743

• Venetoclax plus Zanubrutinib for CLL/SLL in frontline or previously treated patients

  This phase II trial tests if venetoclax plus zanubrutinib can safely and effectively treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma, including those who are newly diagnosed and those who have had prior therapy.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07734038

• Tafasitamab plus Acalabrutinib and Venetoclax for newly treated CLL/SLL

  This phase II study tests a combination of tafasitamab, acalabrutinib, and venetoclax in adults who are newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma to see if it is safe and effective.

  Recruiting at 2 sites Phase 2 City of Hope Medical Center · Duarte, California and 1 other locations · NCT07582159

• Nemtabrutinib and venetoclax in untreated CLL/SLL

  This phase 2 study tests whether combining nemtabrutinib with venetoclax can help people with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07557056

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.