A trial evaluating treatment with ibrutinib plus venetoclax in patients with creatinine clearance = 30 ml/min who have relapsed or refractory chronic lymphocytic leukemia (RR-CLL)
- Conditions
- Chronic Lymphocytic LeukemiaMedDRA version: 21.0Level: LLTClassification code 10009310Term: CLLSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-002599-29-NL
- Lead Sponsor
- HOVON Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 230
• Documented relapsed/refractory CLL or SLL requiring treatment according to IWCLL criteria (no limits on previous treatment lines; CD20 and steroids are not considered prior therapy lines)
• Age at least 18 years.
• Adequate bone marrow function defined as:
- Absolute neutrophil count (ANC) >0.75 x 10^9/L
- Platelet count >30,000 /µL 30 x 10^9/L.
- Hemoglobin >8.0 g/dL (5 mmol/L)
Unless directly attributable to CLL infiltration of the bone marrow, proven by bone marrow biopsy
• Creatinine clearance (CrCL) = 30ml/min .
• Adequate liver function as indicated
- AST or ALT= 3.0 x ULN
- Bilirubin =1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
-Prothrombin time (PT)/International normal ratio (INR) <1.5 x ULN and PTT (activated partial
thromboplastin time [aPTT]) <1.5 x ULN (unless abnormalities are unrelated to coagulopathy or
bleeding disorder).
• Negative serological testing for hepatitis B, negative testing for hepatitis C RNA within 42 days prior to registration.
• WHO/ECOG performance status 0-3 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 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.
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110
• Any prior therapy with ibrutinib and/or venetoclax.
• Transformation of CLL (Richter’s transformation).
• Patients with a history of confirmed progressive multifocal leukoencephalopathy (PML).
• Malignancies other than CLL currently requiring systemic therapies or not being treated in curative intention before or showing signs of progression after curative treatment.
• Known allergy to xanthine oxidase inhibitors and/or rasburicase if no other appropriate prevention of tumorlysis is considered feasible by the treating physician.
• Known bleeding disorders (e.g., von Willebrand’s disease or hemophilia).
• Uncontrolled or active infection.
•Patients requiring treatment with a strong cytochrome P450 (CYP) 3A inhibitor or anticoagulant therapy with warfarin or phenoprocoumon or other vitamin K antagonists.
• History of stroke or intracranial hemorrhage within 6 months prior to randomization.
• Major surgery within 28 days prior to registration.
• Use of investigational agents which might interfere with the study drug within 28 days prior to registration.
• Vaccination with live vaccines within 28 days prior to registration
• Steroid therapy within 7 days prior to registration, with the exception of inhaled steroids for asthma, topical steroids, steroids up to 25 mg of prednisolone daily to control autoimmune phenomenon’s, or replacement/stress corticosteroids.
• Pregnant women and nursing mothers.
• Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method