Status:
RECRUITING
A Pilot Study on Intermittent Ibrutinib in Patients With Advanced-phase Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Jeanette Lundin
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 inc...
Eligibility Criteria
Inclusion
- 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) relapsed and deemed not suitable for additional chemo- or chemoimmunotherapy or c) del 17p and/or TP53 mutation irrespective of prior therapy.
- 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.
Exclusion
- 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 to interpret data from the study.
- 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.
Key Trial Info
Start Date :
February 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04771507
Start Date
February 23 2018
End Date
December 1 2027
Last Update
February 25 2021
Active Locations (9)
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1
St Olavs Hospital
Trondheim, Norway, 7030
2
Falu lasarett
Falun, Dalarna County, Sweden, 791 82
3
Gävle Hospital
Gävle, Gävleborg County, Sweden, 801 87
4
Skåne University Hospital
Lund, Skåne County, Sweden, 222 42