Ibrutinib With or Without Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
- Conditions
- Prolymphocytic LeukemiaRecurrent Chronic Lymphocytic LeukemiaRecurrent Small Lymphocytic Lymphoma
- Registration Number
- NCT02007044
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria:<br><br> - Patients must have a diagnosis of CLL/small lymphocytic lymphoma (SLL) or<br> prolymphocytic leukemia (PLL) and be previously treated; given the poor outcome of<br> CLL/SLL/PLL patients with 17p deletion (del) or tumor protein (TP)53 mutation to<br> standard frontline chemo-immunotherapy, such patients will be eligible if they are<br> untreated<br><br> - Patients must have an indication for treatment by 2008 International Workshop on<br> Chronic Lymphocytic Leukemia (IWCLL) criteria<br><br> - Patients must be age >= 18 years at the time of signing informed consent, understand<br> and voluntarily sign an informed consent, and be able to comply with study<br> procedures and follow-up examinations<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2<br><br> - Patients of childbearing potential must be willing to practice highly effective<br> birth control (e.g., condoms, implants, injectables, combined oral contraceptives,<br> intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the<br> study and for 30 days after the last dose of study drug; women of childbearing<br> potential include any female who has experienced menarche and who has not undergone<br> successful surgical sterilization (hysterectomy, bilateral tubal ligation, or<br> bilateral oophorectomy) or is not postmenopausal<br><br> - Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) except for<br> patients with bilirubin elevation due to Gilbert's disease who will be allowed to<br> participate<br><br> - Alanine aminotransferase (ALT) =< 2.5 x ULN<br><br> - Estimated creatinine clearance (CrCl) of > 30 mL/min, as calculated by the<br> Cockcroft-Gault equation unless disease related<br><br> - Free of prior malignancies for 3 years with exception of patients diagnosed with<br> basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the<br> cervix or breast, who are eligible even if they are currently treated or have been<br> treated and/or diagnosed in the past 3 years prior to study enrollment; if patients<br> have another malignancy that was treated within the last 3 years, such patients can<br> be enrolled, after consultation with the principal investigator, if the likelihood<br> of requiring systemic therapy for this other malignancy within 2 years is less than<br> 10%, as determined by an expert in that particular malignancy at MD Anderson Cancer<br> Center<br><br> - A urine pregnancy test (within 7 days of enrollment date) is required for women with<br> childbearing potential<br><br>Exclusion Criteria:<br><br> - Pregnant or breast-feeding females<br><br> - Prior therapy with ibrutinib or other kinase inhibitors that target Bruton's<br> tyrosine kinase (BTK); patients who previously received therapy with the<br> phosphoinositide-3 kinase (PI3K) delta inhibitor idelalisib (Zydelig) are allowed to<br> be enrolled<br><br> - Treatment including chemotherapy, chemo-immunotherapy, monoclonal antibody therapy,<br> radiotherapy, high-dose corticosteroid therapy (more than 60 mg prednisone daily or<br> equivalent), or immunotherapy within 21 days prior to enrollment or concurrent with<br> this trial<br><br> - Investigational agent received within 30 days prior to the first dose of study drug<br><br> - Systemic fungal, bacterial, viral, or other infection not controlled (defined as<br> exhibiting ongoing signs/symptoms related to the infection and without improvement,<br> despite appropriate antibiotics or other treatment)<br><br> - Patients with uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune<br> thrombocytopenia (ITP)<br><br> - Patients with severe hematopoietic insufficiency, as defined by an absolute<br> neutrophil count of less than 500/uL, unless disease-related, and/or a platelet<br> count of less than 30,000/uL at time of screening for this protocol<br><br> - Any other severe concurrent disease, or have a history of serious organ dysfunction<br> or disease involving the heart, kidney, liver or other organ system that may place<br> the patient at undue risk to undergo therapy with ibrutinib and rituximab<br><br> - Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,<br> congestive heart failure, or myocardial infarction within 6 months of screening, or<br> any class 3 or 4 cardiac disease as defined by the New York Heart Association<br> Functional Classification<br><br> - History of stroke or cerebral hemorrhage within 6 months<br><br> - Evidence of bleeding diathesis or coagulopathy within 3 months<br><br> - Major surgical procedure, open biopsy, or significant traumatic injury within 28<br> days prior to enrollment date, anticipation of need for major surgical procedure<br> during the course of the study<br><br> - Minor surgical procedures, fine needle aspirations or core biopsies within 7 days<br> prior to enrollment date; bone marrow aspiration and/or biopsy are allowed<br><br> - Serious, non-healing wound, ulcer, or bone fracture<br><br> - Treatment with Coumadin; patients who recently received Coumadin must be off<br> Coumadin for at least 7 days prior to start of the study
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival rate
- Secondary Outcome Measures
Name Time Method Incidence of adverse events;Overall response rate;Estimated progression-free survival;Changes in immune parameters (lymphocyte subpopulations, immunoglobulin levels);Quality of life (QOL)