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New treatment option for Chronic Lymphocytic Leukemia
Official title A Pilot Study on Intermittent Ibrutinib in Patients With Advanced-phase Chronic Lymphocytic Leukemia (CLL)
ClinicalTrials.gov ID: NCT04771507
What this study is testing
What is Ibrutinib?
Ibrutinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic lymphocytic leukemia.
Also referred to as Imbruvica.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Ibrutinib, an inhibitor of Bruton´s tyrosine kinase (BTK) is approved in CLL as continuous, daily administration of 420 mg orally until progression. Ibrutinib drug costs in health care are rapidly increasing and are difficult to predict, as long-term follow up analyses have shown that many patients remain on therapy for several years, in some cases even many years.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ability to understand and voluntarily provide written informed consent and comply with the requirements of the study.
- Age 18 years and older. There is no upper age limit in this trial.
- Able to adhere to the study visit schedule and other protocol requirements.
- Before start ibrutinib for the first time: diagnosed with CLL/SLL and active disease in need of treatment after having failed chemoimmunotherapy for...
- Having received at least 6 months of ibrutinib therapy and having achieved at least clinical PR according to IWCLL criteria.
You likely can't join if
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females.
- Any condition, including the presence of laboratory abnormalities, which according to the responsible physician places the subject at unacceptable...
- Use of any other experimental therapy within the last 14 days.
- Concurrent use of other anti-cancer agents or treatments than ibrutinib (except a low dose of corticosteroids, max 10 mg of prednisone/day).
- Positivity for HIV or infectious hepatitis, type A, B or C.
See the full eligibility criteria
- Ability to understand and voluntarily provide written informed consent and comply with the requirements of the study.
- Age 18 years and older. There is no upper age limit in this trial.
- Able to adhere to the study visit schedule and other protocol requirements.
- 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)...
- Having received at least 6 months of ibrutinib therapy and having achieved at least clinical PR according to IWCLL criteria.
- ECOG performance status of \</= 2 at screening.
- 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
- 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.
- Agree to use reliable forms of contraception. Post-menopausal females and surgically sterilized females are exempt from this criterion.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females.
- 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...
- Use of any other experimental therapy within the last 14 days.
- Concurrent use of other anti-cancer agents or treatments than ibrutinib (except a low dose of corticosteroids, max 10 mg of prednisone/day).
- Positivity for HIV or infectious hepatitis, type A, B or C.
- Opportunistic infections within the last 3 months.
- Patient planned for or being a potential candidate for allo-SCT.
- Uncontrolled hemolytic anemia or autoimmune thrombocytopenia.
- CNS involvement or history of Richter's transformation.
- Requires or has received anticoagulation treatment with warfarin or equivalent Vitamin K antagonists (eg, phenprocoumon) within 28 days of the first dose of ibrutinib.
- Requires treatment with a strong cytochrome P450 (CYP) 3A4/5 inhibitor.
The study team makes the final eligibility decision.
Where it's taking place
- Trondheim, Norway
- Falun, Dalarna County, Sweden
- Gävle, Gävleborg County, Sweden
- Lund, Skåne County, Sweden
- Gothenburg, Sweden
- Örebro, Sweden
- Stockholm, Sweden
- Umeå, Sweden
- Uppsala, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Trondheim, Norway; Falun, Dalarna County, Sweden; Gävle, Gävleborg County, Sweden; Lund, Skåne County, Sweden; Gothenburg, Sweden; Örebro, Sweden and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.