EUCTR2013-003211-22-DEActive, not recruitingPhase 1
A Placebo-Controlled, Double-Blind, Randomized, Multicenter, Three Arm Phase III Trial to Compare the Efficacy and Safety of Ibrutinib vs. Placebo in Previously Untreated Binet Stage A CLL Patients with Risk of Early Disease Progression
niversity of Cologne0 sites540 target enrollmentStarted: February 4, 2014Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 540
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Inclusion-Criteria:
- •Confirmed diagnosis of previously untreated CLL according to the updated iwCLL guidelines
- •Stage Binet A without need for treatment
- •Age = 18 years
- •Life expectancy = 6 months
- •ECOG performance status 0 – 2
- •Absolute neutrophil count (ANC = 1 x 109 / L)
- •Signed written informed consent of patient and treating physician
- •Females of childbearing potential (FCBP)† in the experimental treatment arm (placebo / ibrutinib) must:
- •Have one negative medically supervised pregnancy test prior to starting the study therapy.
- •Either commit to continued abstinence from heterosexual intercourse or agree to use, and be able to comply with, two reliable forms of effective contraception simultaneously to achieve a PEARL-Index <1 without interruption (Highly effective methods: Intrauterine device (IUD), Hormonal (birth control pills, injections, implants), Tubal ligation, Partner’s vasectomy, Additional effective methods: Male condom, Diaphragm, Cervical Cap), 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 30 days after discontinuation of study therapy
- •Male subjects in the experimental treatment arm (placebo / ibrutinib) must:
- •Agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
- •Agree to not donate semen during study drug therapy and for a period after end of study drug therapy.
- •For males these restrictions apply for 3 months after the last dose of study medication.
- •All subjects in the experimental treatment arm (placebo / ibrutinib) must:
- •Have an understanding that the study drug could have a potential teratogenic risk.
- •Agree not to share study medication with another person.
- •Be counseled about pregnancy precautions and risks of fetal exposure.
- •Willingness to inform the general practicioner
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 216
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 324
Exclusion Criteria
- •Exclusion-Criteria:
- •Any prior CLL specific therapy
- •Recent therapeutic interventions including:
- •-All other chemotherapy, radiation therapy within 3 weeks prior to randomization
- •-Any surgery within 4 weeks prior to randomization
- •Prior treatment with Ibrutinib or BTK inhibitors
- •Chronic use of steroids in excess of prednisone 20mg/day or its equivalent
- •Active infections requiring systemic antibiotics
- •An life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion could compromise the subject’s safety, interfere with the absorption or metabolism of Ibrutinib capsules, or put the study outcomes at undue risk
- •Pregnant or lactating females
- •Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging. Subjects who have signs or symptoms suggestive of leukemic meningitis or a history of leukemic meningitis must have a lumbar puncture procedure performed within two weeks prior to randomization
- •Known second malignancy that limits survival to less than two years
- •Known Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV) and/or active Hepatitis C Virus (HCV) infection.
- •Any of the following laboratory abnormalities:
- •a.Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 2.5 x upper limit of normal (ULN)
- •b.Serum total bilirubin > 1.5 ULN (with the exception of Gilbert’s Syndrome)
- •c.Creatinine clearance < 30ml/min
- •Requires anticoagulant with warfarin or phenoprocoumon
- •Requires anticoagulant with oral direct Xa inhibitors (rivaroxaban, apixaban, edoxaban)
- •History of stroke or intracranial hemorrhage within 6 months prior to randomization
- •Requires treatment with strong CYP3A4/5 inhibitors (see section 8.6.3)
- •Participation in any clinical study for CLL or having taken any investigational therapy which would interfere with the study drug for a disease other than CLL within 28 days prior to initiating treatment.
- •Prisoners or subjects who are institutionalized by regulatory or court order or persons who are in dependence to the sponsor or an investigator
- •Patients with uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia
Investigators
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