A Study of the Safety and Efficacy of Venetoclax for Participants With Chronic Lymphocytic Leukemia...
CancerChronic Lymphocytic Leukemia (CLL)This observational study will evaluate the safety and effectiveness of Venetoclax used in routine clinical practice for participants diagnosed with chronic lymphocytic leukemia (CLL).
Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Refractory...
B-cell Non Hodgkin LymphomaChronic Lymphocytic LeukemiaThis is a single-center, nonrandomized, open-label dose-escalation study followed by dose-expansion of CD19- CD34t metabolically programmed CAR T-cell therapy in adult patients with relapsed or refractory CD19 B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Nutritional Intervention in Acute Lymphoblastic Leukemia
Acute Lymphoblastic LeukemiaChildhood Cancer2 moreIntroduction: Annually 400,000 children are diagnosed with cancer in the world. Approximately 90% live in low/middle-income countries, with survival rates of 10-30%. In Mexico, children and adolescents' hospital admissions for cancer are mainly leukemias (46%), being acute lymphoblastic leukemia (ALL) the most common. Half of ALL patients have an altered nutritional status at the time of diagnosis. Nutritional assessment is performed using conventional anthropometric measures, which are not sensitive to changes in fat-free mass and fat mass (FFM and FFM). Our objective is to evaluate the effect of an individualized food-based nutritional intervention according to the nutritional status, body composition and comorbidities in pediatric patients with ALL. This is a pre-test/post-test clinical trial. Children 2-14 y olds diagnosed with ALL and in the remission stage (4-6 weeks post-diagnosis) will participate. The nutritional status will be evaluated using questionnaires and body composition. The intervention will be a 6 mo individualized food-based nutrition plan changing meal plans every 2 wk; every plan provides 5 interchangeable meals, adapting to personal preferences and symptoms related to antineoplastic treatment (nausea, diarrhea, taste alteration, etc.). For hospitalized patients, the options offered by the hospital will be evaluated and adapted to the nutritional intervention. Effectiveness of the intervention will be assessed using a paired test dependant on the distribution of the data.
Pharmacokinetics of Venetoclax in Patients With Chronic Lymphocytic Leukemia
Chronic Lymphocytic LeukemiaVenetoclax is a treatment for chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). However, the pharmacokinetic data in Chinese population, as well as the change of venetoclax plasma concentration while taking CYP enzyme inducers or inhibitors, remained unknown so far. Therefore, the aim of this study is to investigate the pharmacokinetic characteristics of venetoclax.
CAP-100 for Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia
Lymphocytic LeukemiaChronic1 moreIntroduction of immuno-chemotherapy in the treatment options of CLL and SLL changed the treatment paradigm of these diseases. Presently, first-line therapies for CLL/SLL include targeted therapies (e.g. ibrutinib, acalabrutinib) or combined immuno-chemotherapy regimens (e.g., fludarabine, cyclophosphamide, and rituximab for patients aged <65 years without del17p/TP53 mutations or bendamustine and rituximab for patients ≥65 years who have additional comorbidities). Despite the gradual introduction of targeted therapies, new treatment strategies efficacious for patients ineligible for/unresponsive to these therapies are still required. These new strategies should ideally overcome disease relapse and circumvent compound-specific safety challenges. Emerging treatment options include new compounds aimed for both untreated and relapsed/refractory CLL, and combination therapies of existing compounds that extend single-agent efficacy in specific high-risk patient populations. CAP-100 is expected to prevent the migration of leukemia cells to and their survival in lymphoid niches as well as to eliminate CCR7-positive leukemia cells via ADCC, resulting in measurable clinical responses. The present trial is the first-in-human trial of CAP-100 and is divided into two phases. The aim of the Phase Ia (dose escalation) is to define the Recommended Phase 2 Dose (RP2D) versus the Maximum Tolerated Dose (MTD) of CAP-100 in subjects with CLL. Phase Ib of the trial (expansion phase) will evaluate the safety and preliminary clinical benefit of CAP-100 monotherapy at RP2D (response rate, lymph node size reduction, assessment of minimal residual disease [MRD]) to support the design of future trials investigating CAP-100 either as monotherapy or in a combination setting with approved treatments for CLL.
Zebutinib Combined With Immunochemotherapy in the Treat of Newly Treated CLL Patients Without 17p-/TP53...
Chronic Lymphocytic LeukemiaTo investigate limited course of treatment of Zebutinib combined with immunochemotherapy for patients with newly treated chronic lymphocytic leukemia without 17p-/TP53 mutation
Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 OVERALL
CD20-positive Acute Lymphoblastic LeukemiaA multicenter, prospective, randomized and controlled study to compare the efficacy and safety of obinutuzumab and rituximab in adult ALL patients with CD20 expression.Study population is 124 patients (62 in each study group).
Post-Frontline Sequential Treatment of Adult Philadelphia Chromosome-Positive Acute Lymphoblastic...
Acute Lymphoblastic LeukemiaThe primary objective of the present study is to evaluate the long-term observation, in terms of overall survival, of adult Ph+ ALL patients treated frontline with the sequential administration of dasatinib and the bispecific monoclonal antibody blinatumomab according to GIMEMA protocol LAL2116.
Healthy Bones, Healthy Life: Habitual Physical Activity on Bone & Metabolic Health in Pediatric...
Acute Lymphoblastic LeukemiaPediatric12 moreThis project will examine habitual physical activity, bone health, and insulin resistance in pediatric acute lymphocytic leukemia (ALL) and lymphoma cancer survivors at two time points: baseline and 6 months. At the two study timepoints, all study participants will be asked to wear an accelerometer, receive a DXA scan of the lumbar spine and hip, and have blood drawn for analysis. Study participants will be given a gift card stipend for each study visit attended. Study visits will coincide with regular office visits to Children's Hospital Oncology Clinic and the Children's Hospital Survivorship Clinics whenever possible. The potential mechanism by which physical activity mediates bone changes will be explored by concurrently measuring changes in lean/fat mass and metabolic status. This pilot study will provide data to inform the design of a randomized controlled trial to test the effect of a physical activity intervention on bone health in PCS.
A Study of GC019F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL
B-cell Acute Lymphoblastic LeukemiaThe study is an early, open, single-centered trial. The aim of this study is to evaluate the safety and tolerance of GC019F CAR-T cell immunotherapy in relapsed or refractory B-ALL. The study will include 6-12 subjects to receive GC019F therapy.