A Prospective, Multicenter, Phase-II Trial of Venetoclax Plus Acalabrutinib in Patients Who Have Relapsed After First Line Venetoclax + Anti-CD20 mAb Treatment for Chronic Lymphocytic Leukemia (CLL or SLL)
Fixed-duration regimens containing combinations of venetoclax with CD20 targeting agents are expected to soon become standard practice in first-line patients with chronic lymfocytic leukemia (CLL). The advantage of a fixed duration venetoclax combination as part of first-line treatment is the potential to retreat with venetoclax in patients who develop relapsed disease after a treatment free period. However, efficacy of venetoclax retreatment following a fixed duration venetoclax combination is still hypothetical as clinical data are lacking. Thus, there is an urgent need for data proving efficacy of venetoclax combinations following venetoclax treatment cessation. Testing of a novel venetoclax-containing regimen for relapsed CLL without the repeat of anti-CD20 monoclonal antibody (mAb) is a rational approach.
NCT04523428 — CLL/SLL
Status: Recruiting
http://inclinicaltrials.com/cll-sll/NCT04523428/
Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study)
Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia
NCT04502030 — Chronic Lymphocytic Leukemia
Status: Recruiting
http://inclinicaltrials.com/chronic-lymphocytic-leukemia/NCT04502030/
Phase II Expansion Cohorts Studies of a Novel Triple Combination Therapy, DTRM-555, in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Relapsed/Refractory Non-Hodgkin's Lymphomas
Targeted drug therapies have greatly improved outcomes for patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma. However, single drug therapies have limitations, therefore, the current study is evaluating a novel oral combination of targeted drugs as a way of overcoming these limitations. This study will determine the efficacy of the triple combination therapy, DTRM-555, in patients with R/R CLL or R/R non-Hodgkin's lymphoma.
NCT04305444 — Follicular Lymphoma
Status: Recruiting
http://inclinicaltrials.com/follicular-lymphoma/NCT04305444/
A Phase I, Open-Label, Multicenter Study of FT596 as a Monotherapy and in Combination With Rituximab or Obinutuzumab in Subjects With Relapsed/Refractory B-cell Lymphoma and Chronic Lymphocytic Leukemia
This is a Phase I dose-finding study of FT596 as monotherapy and in combination with Rituximab or Obinutuzumab in subjects with relapsed/refractory B-cell Lymphoma or Chronic Lymphocytic Leukemia. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
NCT04245722 — Chronic Lymphocytic Leukemia
Status: Terminated
http://inclinicaltrials.com/chronic-lymphocytic-leukemia/NCT04245722/
A Phase I/Ib Open-label, Multi-center Dose Escalation Study of JBH492 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)
The purpose of the First-In-Human study is to assess safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of JBH492 as single agent.
NCT04240704 — Chronic Lymphocytic Leukemia
Status: Active, not recruiting
http://inclinicaltrials.com/chronic-lymphocytic-leukemia/NCT04240704/
Effect of Dietary Intervention With High-Oleocanthal and Oleacin Extra Virgin Olive Oil in Patients With Chronic Lymphocytic Leukemia a Pilot Study
Daily intake of extra virgin olive oil (EVOO), which is the major component of the Mediterranean diet and also a source of monounsaturated fat, may be partly responsible for the increased life expectancy of the Mediterranean people. A high dietary intake of EVOO is correlated with lower incidence of cancer, cardiovascular disease, metabolic diseases, Alzheimer's disease and osteoporosis Oleocanthal, a phenolic derivative of extra virgin olive oil, has important health promoting anti-cancerous properties, since it can inhibit the growth and promote the apoptosis of several cancer cells. The purpose of the present study was to investigate the effect of dietary intake of olive oil rich in oleocanthal on hematological, metabolical, cell progression markers and disease progression in patients with Chronic Lymphocytic Leukemia. The aim is also to study the possible association of apoptosis in the mechanism of action of virgin olive oil phenols in a patient with CLL in order to find the possible mechanism of the cellular action of oleocanthal in neoplasia. After the screening of >300 EVOO samples the investigators selected an EVOO with high oleocanthal and oleacin concentration of 416 and 284 mg/Kg respectively (EVOO OC/OL). Pilot dietary intervention was made in a group of 21 patients with chronic lymphocytic leukemia (CLL) who did not follow any treatment. EVOO was administered 40 ml/day for six months. Biochemical, hematological and molecular markers were studied six month before the intervention and six month during the intervention
NCT04215367 — Chronic Lymphocytic Leukemia (CLL)
Status: Completed
http://inclinicaltrials.com/chronic-lymphocytic-leukemia-cll/NCT04215367/
Venetoclax (Venclexta Tablet) Post-Marketing Surveillance for CLL Patients
This observational study will evaluate the safety and effectiveness of Venetoclax used in routine clinical practice for participants diagnosed with chronic lymphocytic leukemia (CLL).
NCT04178317 — Cancer, Chronic Lymphocytic Leukemia (CLL)
Status: Recruiting
http://inclinicaltrials.com/cancer-chronic-lymphocytic-leukemia-cll/NCT04178317/
Quality Assurance on Diagnosis and Therapy of Secondary Immunodeficiencies (SID) in Patients With Chronic Lymphocytic Leukemia (CLL) or Multiple Myeloma (MM) in Germany (QS-SID)
Retrospective, representative registry for quality assurance on diagnosis and therapy of secondary immunodeficiencies (SID) in patients with chronic lymphocytic leukemia (CLL) or multiple myeloma (MM)
NCT04172467 — Secondary Immunodeficiencies (SID)
Status: Completed
http://inclinicaltrials.com/secondary-immunodeficiencies-sid/NCT04172467/
A Prospective Cohort of Obinutuzumab and Chlorambucil (GC) Chemotherapy for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia Including Next- Generation Sequencing (NGS)-Based Assessment
This study is prospective, open-label, single arm observational study to assess efficacy of obinutuzumab plus chlorambucil (GC) chemotherapy in treatment naïve CLL, and prognostic impact of genetic alterations for CLL using NGS.
NCT04059081 — Chronic Lymphocytic Leukemia
Status: Recruiting
http://inclinicaltrials.com/chronic-lymphocytic-leukemia/NCT04059081/
A Phase 2 Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Subjects With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax
Phase 2, two cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with Chronic Lymphocytic Leukemia (CLL), who are currently on treatment with ibrutinib, alacabrutinib or venetoclax.
NCT04016805 — Chronic Lymphocytic Leukemia
Status: Terminated
http://inclinicaltrials.com/chronic-lymphocytic-leukemia/NCT04016805/