A Phase II Study of Venetoclax and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL)
This phase II trial studies how well venetoclax and ibrutinib work in treating patients with chronic or small lymphocytic leukemia. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax and ibrutinib may help control chronic or small lymphocytic leukemia.
NCT02756897 — Chronic Lymphocytic Leukemia
Status: Active, not recruiting
http://inclinicaltrials.com/chronic-lymphocytic-leukemia/NCT02756897/
Minimal Residual Disease Eradication With Ibrutinib Therapy (MERIT) in Patients With Chronic Lymphocytic Leukemia After Frontline Therapy
This phase II trial studies the side effects and how well ibrutinib works in treating patients with chronic lymphocytic leukemia who responded to initial treatment used to reduce a cancer (front-line therapy) but have residual disease. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
NCT02649387 — Stage IV Chronic Lymphocytic Leukemia
Status: Active, not recruiting
http://inclinicaltrials.com/stage-iv-chronic-lymphocytic-leukemia/NCT02649387/
First-Line Therapy With Ibrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (GA-101) (iFCG) for Patients With Chronic Lymphocytic Leukemia (CLL) With Mutated IGHV Gene and Non-Del(17p)
This phase II trial studies how well ibrutinib, fludarabine phosphate, cyclophosphamide, and obinutuzumab work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving ibrutinib, fludarabine phosphate, cyclophosphamide, and obinutuzumab together may work better in treating chronic lymphocytic leukemia.
NCT02629809 — Chronic Lymphocytic Leukemia
Status: Active, not recruiting
http://inclinicaltrials.com/chronic-lymphocytic-leukemia/NCT02629809/
A Quality Improvement Approach to the Management of Chronic Lymphocytic Leukemia
This project addresses the need to improve physician knowledge and clinical practice patterns related to quality of life (QoL) concerns for patients with chronic lymphocytic leukemia (CLL).
NCT02619604 — Chronic Lymphocytic Leukemia
Status: Completed
http://inclinicaltrials.com/chronic-lymphocytic-leukemia/NCT02619604/
A Phase I Study of Buparlisib (BKM120) and Ofatumumab or Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
This phase I trial studies the side effects and best dose of buparlisib when given together with ofatumumab or ibrutinib in treating patients with chronic lymphocytic leukemia that has returned after a period of improvement or does not respond to treatment. Buparlisib and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as ofatumumab, may block cancer growth in different ways by targeting certain cells. Giving buparlisib or ibrutinib and ofatumumab together may work better in treating patients with chronic lymphocytic leukemia.
NCT02614508 — Recurrent Small Lymphocytic Lymphoma
Status: Terminated
http://inclinicaltrials.com/recurrent-small-lymphocytic-lymphoma/NCT02614508/
informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
The study is designed as a multicenter, prospective, observational registry of CLL/SLL patients who are initiating approved oral kinase inhibitors, BCL-2 inhibitors or other approved anti-CLL therapies/regimens. The study will characterize treatment patterns and their association with patient characteristics, healthcare resource utilization, and clinical outcomes, as well as patient-reported outcome (PRO) measures.
NCT02582879 — Chronic Lymphocytic Leukemia (CLL)
Status: Completed
http://inclinicaltrials.com/chronic-lymphocytic-leukemia-cll/NCT02582879/
A Retrospective Study to Evaluate the Clinical-Biologic Characteristics and Outcome of Patients Treated in Italy According to the Ibrutinib-Named Patient Program for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
This is a retrospective observational study aimed at describing the characteristics and outcome of CLL patients included in the NPP in Italy in a period of time ranging from the start of the NPP until November, 30th 2014. A longitudinal survey will be carried out by collecting data of patients who received at least 1 dose of Ibrutinib. All patients will be observed for at least 12 months from the treatment start.
NCT02582320 — Chronic Lymphocytic Leukemia
Status: Completed
http://inclinicaltrials.com/chronic-lymphocytic-leukemia/NCT02582320/
A Pilot Study of Vitamin D Replacement in Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia With Low Vitamin D Levels
This randomized pilot early phase I trial studies how well cholecalciferol works in treating patients with newly diagnosed non-Hodgkin lymphoma or chronic lymphocytic leukemia with low levels of vitamin D (vitamin D deficiency). Cholecalciferol may increase levels of vitamin D and improve survival in patients with non-Hodgkin lymphoma or chronic lymphocytic leukemia receiving standard of care chemotherapy.
NCT02553447 — Chronic Lymphocytic Leukemia
Status: Active, not recruiting
http://inclinicaltrials.com/chronic-lymphocytic-leukemia/NCT02553447/
Molecular Features Underlying Racial Differences in Survival of Taiwanese Chronic Lymphocytic Leukemia Patients
Chronic lymphocytic leukemia (CLL) is the most common leukemia in adults in Western countries; it is stratified as a subtype of indolent lymphoid malignancy with a long but slowly progressive nature history. However, the clinical course of CLL actually varies widely. Thus, many clinical and molecular features have been identified for outcome predictions. The accurate predictions of prognosis through those factors help for the decision making on the treatment, i.e. to treat patients of high risk of early progression or poor overall survival (OS) with alternative or investigational therapies, while to avoid unnecessary over-treatment for low-risk patients. CLL is much less prevalent in Eastern countries; presently, most available data on CLL are derived mainly from Western countries. However, a previous report concerning the epidemiology of CLL in Taiwan revealed a drastic increase in the age-adjusted incidence of CLL, a trend not found in Western countries where the incidence rate of CLL remained steadily stable over time. In addition to this epidemiological difference, a population-based analysis has found the overall outcome of CLL, estimated by relative survivals, is steadily much poorer in Taiwanese patients than in US Caucasians. In another report about the cytogenetic profiles in a small cohort of CLL patients in Taiwan, a novel cytogenetic abnormality was found to correlate with poorer outcomes. These reports suggest the existence of ethnic differences in the disease natures of CLL between the East and the West. To delineate the possible underlying racial differences, especially in the molecular prognostic profiles that might underlie the outcome disparity between Taiwanese and western CLL patients, a comprehensive surveillance of the molecular profiles for CLL in Taiwan is of importance. In this study, we are going to enroll around 250 CLL patients; their clinical parameters will be recorded, their blood samples will be collected for a panel of molecular and cytogenetic factor studies. The molecular markers to be tested in this project include (but not limited to) cytogenetic abnormalities by fluorescent-in-situ hybridization (FISH), immunoglobulin heavy chain variable region (IGHV) hypermutation status, gene mutations for Notch1, SF3B1, p53, MyD88, and BIRC3, and the expressions for ZAP70 and stem cell factor (SCF). These proposed markers include not only the conventional prognostic markers derived from Western studies, and also some novel explorations from our preliminary results, such as SCF and trisomy 3. Through this study, a comprehensive profile of CLL in Taiwan will be established to identify the characteristics of CLL in Taiwanese patients and to address the underlying factors of ethnic differences in the disease nature and outcomes of this disease.
NCT02553304 — Chronic Lymphocytic Leukemia (CLL)
Status: Completed
http://inclinicaltrials.com/chronic-lymphocytic-leukemia-cll/NCT02553304/
A Phase 1b/2 Study of Idelalisib in Combination With BI 836826 in Subjects With Chronic Lymphocytic Leukemia
This study consists of 2 parts: Phase 1b and Phase 2. Phase 1b will evaluate the safety and tolerability of the combination of idelallisib with the anti-CD37 monoclonal antibody BI 836826 in participants with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), and establish the high recommended Phase 2 combination dose (highRP2D) as well as an alternate lower recommended Phase 2 combination dose (lowRP2D). Phase 2 will determine the rates of complete response (CR) and of minimal residual disease (MRD) negativity with the combination at the highRP2D and the lowRP2D in participants with R/R CLL.
NCT02538614 — Chronic Lymphocytic Leukemia (CLL)
Status: Terminated
http://inclinicaltrials.com/chronic-lymphocytic-leukemia-cll/NCT02538614/