Status and phase
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About
The aim of the current trial is to evaluate if combination treatment with venetoclax + ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (RR CLL) can lead to MRD negativity, which may induce long lasting remissions for MRD-negative patients randomized to stopping treatment after 15 induction cycles.
Enrollment
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Volunteers
Inclusion criteria
Documented CLL or SLL requiring treatment according to IWCLL criteria after either being refractory to first line therapy or relapse after initial therapy.
Age at least 18 years.
Adequate bone marrow function defined as:
Creatinine clearance (CrCL) ≥ 30ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured with 24hr urine collection.
Adequate liver function as indicated
Negative serological testing for hepatitis B (HBsAg negative and anti-HBc negative; patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBV-DNA PCR is performed every month until 12 months after last dose), negative testing for hepatitis C RNA within 42 days prior to registration.
WHO/ECOG performance status 0-3 (appendix C), stage 3 only if attributable to CLL.
Negative pregnancy test at study entry (for women of childbearing potential).
Male and female subjects of reproductive potential must agree to use both a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence , or sterilized partner) and a barrier method (e.g., condoms, cervical ring, sponge, etc.) during the period of therapy and for 90 days after the last dose of study drug.
Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements.
Written informed consent.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
230 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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