View clinical trials related to Chronic Lymphocytic Leukemia (CLL).
Filter by:Objectives of this clinical trial are to evaluate the safety, tolerability, pharmacokinetics and potential efficacy of the investigational drug, cobomarsen (MRG-106), in patients diagnosed with certain lymphomas and leukemias, including cutaneous T-cell lymphoma (CTCL) [mycosis fungoides (MF) subtype], chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL) [activated B-cell (ABC) subtype], and adult T-cell leukemia/lymphoma (ATLL). Cobomarsen is an inhibitor of a molecule called miR-155 that is found at high levels in these types of cancers and may be important in promoting the growth and survival of the cancer cells. Participants in the clinical trial will receive weekly doses of cobomarsen administered by injection under the skin or into a vein, or by injection directly into cancerous lesions in the skin (for CTCL only). Blood samples will be collected to measure how cobomarsen is processed by the body, and other measurements will be performed to study how normal and cancerous cells of the immune system respond when exposed to cobomarsen.
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.
This research study will be evaluating the safety and efficacy of a study drug called TGR-1202 in combination with a known drug ibrutinib, also known as Imbruvica, as a possible treatment for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Mantle Cell Lymphoma (MCL) that has come back or that has not responded to standard treatment.
This study is evaluating the safety, pharmacokinetic profile and efficacy of venetoclax under a once daily dosing schedule in Japanese participants with hematological malignancies.
Background: - Stem cell transplantation from a partially matched donor can lead to graft-versus-host disease (GVHD). Researchers want to learn how to improve these transplantations. Objective: - To see if very low doses of Interleukin-2 after a partially matched transplantation prevent GVHD. Eligibility: - Recipients: age 18 65, with certain bone marrow or lymphatic system diseases and an available family member with partial tissue match. - Donors: age 18 80. Design: - Recipients will be screened with medical history, physical exam, and many tests including blood and tissue tying. - Donors will be screened with medical history, physical exam, blood tests and tissue typing. - Recipients will stay in the hospital 3 6 weeks. - All participants will have apheresis. Blood is drawn from one arm, run through a machine that collects white blood cells, then returned into the other arm. - Recipients will have: - Intravenous (IV) line placed under the skin and into a neck vein, to stay throughout transplant and recovery. They may also have a catheter inserted for collecting immune cells. - Bone marrow sample taken by needle. They will have 3 more after transplant. - Donors will have: - Filgrastim injected once daily for 5 6 days. - Stem and immune cells collected by another apheresis. - Recipients will get: - Eight 30-minute doses of radiation, sitting at a machine. - Donor immune cells by IV, 6 days before the transplant day. - Chemotherapy drugs by IV. <TAB><TAB>- Donor stem cells by IV on transplant day. - After transplant, recipients will give self-injections of very low doses of Interleukin-2 once daily for about 12 weeks. - Before and after transplant, recipients will get medicine to suppress the immune system and antibiotics to prevent infections - Recipients must stay near NIH for 3 6 months after transplant. - All recipients and donors will have 3 years of follow-up.
This study will identify the highest dose, and assess the safety, of cerdulatinib (PRT062070) that may be given in participants with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or non-hodgkin lymphoma.
This is a multi-center, phase I/II clinical trial for patients who have relapsed more than 60 day after allogeneic transplant for a hematologic malignancy. The study consists of two phases. The dose finding phase is a modified version of a phase I trial and the extended phase is a modified version of a phase II trial. The primary objective of the dose finding phase is to determine the maximum tolerated, minimum efficacious dose (MTD/MED) of a interleukin-15 (IL-15) super agonist complex (ALT-803) when given once weekly for 4 weeks in the outpatient setting. The study will follow a standard 3+3 design of dose escalation for toxicity with an added feature of stopping early if efficacy is confirmed. There are six dose levels of ALT-803 for to determine the MTD/MED: 1, 3, 6, 10, 20, and 30 mcg/kg. Once the MTD/MED for ALT-803 is determined, this cohort will be used in the extended phase. The primary goal of this extended phase is to study the potential efficacy of ALT-803 in this patient population. Efficacy will be measured using rates of remission induction. An optimal Simon's two-stage design will be used in this phase. Stage 1 will enroll 14 patients (including the 6 patients treated at the MTD/MED during the dose finding phase). If 3 or more of these 14 patients respond to ALT-803, the trial will move to stage 2 and enroll an additional 23 patients. If 2 or fewer respond, the study will terminate enrollment early.
The purpose of this study is collect and evaluate the clinical experience reached in Italy on the use of bendamustine alone or combined with rituximab as treatment of patients with relapsed or refractory chronic lymphoproliferative disorders.
The main aims of this clinical study are to find out the maximum dose that can be given safely to patients, the potential side effects of the drug and how they can be managed. The study will also look at what happens to Anti-CD19 (DI-B4) inside the body. DI-B4 is a type of drug called an Anti-CD19 monoclonal antibody which is being used to stop the growth and kill cancerous immune cells by targeting the B-cell marker (CD-19) expressed on their surface. This drug has not been given to patients before. DI-B4 will be given weekly by intravenous infusion for four weeks. The study is in two parts. In Part 1, small groups of patients will be treated at increasing doses to find the highest safest dose and best dose for part 2 of the study. Approximately 16-20 patients will be treated in this part. In Part 2, the dose identified in Part 1 will be given to approximately 20 patients. Patients recruited to the study will receive four weeks (cycles) of treatment. They will attend an end of therapy visit eight weeks after their last dose of DI-B4, and attend follow-up visits up to eighteen months after their first dose of DI-B4. Information on the overall and progression free survival will be collected for a period up to eighteen months after the final patient is treated on the study. Patients will have blood and urine samples taken each week during treatment amongst other clinical tests. CT scans will be performed at the start of the study, at eight weeks post treatment and six months after the study start. Bone marrow biopsies and FDG-PET scans will only be taken if needed. Research blood samples will also be taken to look at what happens to the drug inside the body. It is important to explain that patients will have advanced cancer so it is unlikely that patients will benefit directly from taking part but the study may help improve future treatment of cancer.
Hematopoietic progenitor cell (HPC- primitive cells in the blood, bone marrow and umbilical cord that can restore the bone marrow) transplant can be a curative therapy for the treatment of hematologic malignancies (a disease of the bone marrow and lymph nodes). The source of cells used for the transplant comes from related (sibling) and in cases where there is no sibling match, from unrelated donors through the National Marrow Donor Program. The availability of a suitable donor can be a significant obstacle for patients who need a transplant but do not have a matched donor. Cord blood that has been harvested from an umbilical cord shortly after birth has a rich supply of cells needed for transplant. These stored cord bloods are now being used to transplant adults without a matched donor Advantages to using cord blood includes a readily available source of cells with no risk to the donor during the collection process, immediate source of cells in urgent situations (no lengthy donor work-up)and a reduction in infectious disease transmission to the recipient. One of the main disadvantages is the cord blood has a small number of cells needed for transplant. In an adult, usually two cords are needed and large recipients do not qualify because they need too many cells. This study will use two different preparative regimens (chemotherapy and radiation) followed by one or two umbilical cord units (UBC). The preparative regimen used will be chosen by the physician and is based on patient's age, disease and medical condition at the time of transplant. Multiple objectives for this study include disease-free and overall survival, treatment related mortality, rate of cells taking hold, and the incidence and severity of the transplant complication called graft versus host disease (GVHD).