Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia...
Pediatric Patients With Acute Lymphoblastic LeukemiaThis is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with Acute Lymphoblastic Leukemia.
T-Regulatory Cell and CD3 Depleted Double Umbilical Cord Blood Transplantation in Hematologic Malignancies...
Hematologic MalignancyAcute Myeloid Leukemia17 moreThis is a unique dose-escalation trial that will titrate doses of umbilical cord blood (UCB) Treg and CD3+ Teff cells with the goal of infusing as many CD3+ Teff cells as possible without conferring grade II-IV acute graft-versus-host disease (GVHD). In this study, the investigators propose to add UCB Treg and UCB CD3+ Teff cells to the two TCD UCB donor units with the goal of transplanting as many CD3+ Teff cells as possible without reintroducing risk of acute GVHD. The investigators hypothesize that Treg will permit the reintroduction of CD3+ Teff cells that will provide a bridge while awaiting HSC T cell recovery long term. The co-infusion of Treg will prevent GVHD without the need for prolonged pharmacologic immunosuppression.
Dose Escalation Study in Acute Myeloid or B-Cell Acute Lymphoblastic Leukemia
Relapsed or Refractory Acute Myeloid LeukemiaRelapsed or Refractory B-Cell Acute Lymphoblastic LeukemiaThe main purpose of this study is to test the safety and efficacy of VS-4718 in two types of leukemia patients and to find the right dose of VS-4718 for future clinical trials. Other purposes of this study include: Testing for study drug VS-4718 levels in blood over time and what happens to the study drug in patients. To find out if there are certain biomarkers in leukemia patients that predict if and how 4718 study drug may or may not work.
HuMax-CD20 in Chronic Lymphocytic Leukemia
Chronic Lymphocytic LeukemiaThe purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Chronic Lymphocytic Leukemia.
HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine...
HepatitisSafety and TolerabilityBackground: People with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) tend to get infections more easily. This is because their immune systems are weakened. Hepatitis B is a virus that can be transmitted when body fluids from an infected person enter the body of an uninfected person. This virus can be dangerous for people with leukemia and lymphoma. HEPLISAV-B is a new hepatitis B vaccine. Researchers want to see if it can protect people with CLL/SLL from getting hepatitis B. Objective: To learn how HEPLISAV-B works in people who have CLL or SLL. Eligibility: Adults 18 years and older with CLL (or SLL). They must be getting no treatment for their CLL, or getting ibrutinib or acalabrutinib for it. Design: This study lasts 6 months from the date of first vaccination. Participants may be screened with: Physical exam Blood tests Pregnancy test Visit 1 Participants will get blood drawn and the study vaccine. It will be given as an injection. If they get any symptoms within 7 days of the vaccine, they will write them in a diary. Visit 2 After 3 months, participants will come back to the NIH to get another blood draw and the second vaccine dose. Visit 3 Participants will return 3 months after the second vaccine dose was given. They will have blood drawn.
Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small...
Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaThis is a multi-center, single-arm, open-label, Phase 2 study of duvelisib, an orally bioavailable dual inhibitor of PI3K-δ,γ, in patients with CLL/SLL who have previously been treated with ibrutinib or another Bruton's Tyrosine Kinase Inhibitor (BTKi) and relapsed or were refractory to such therapy or discontinued such therapy due to toxicity.
Modified Immune Cells (CD19-CD22 CAR T Cells) in Treating Patients With Recurrent or Refractory...
CD19 PositiveCD22 Positive8 moreThis phase I/II trial studies the side effects and best dose of modified immune cells called CD19-CD22 chimeric antigen receptor (CAR) T cells in treating patients with CD19 positive(+), CD22+ B-acute lymphoblastic leukemia, chronic lymphocytic leukemia, or non-Hodgkin's lymphoma that has come back (recurrent) or does not respond to treatment (refractory). T-cells are collected from the patient and genetic materials called "chimeric antigen receptors (CAR)" are transferred to the collected T-cells. The CAR T-cells are then infused back to the patient's body. Giving CD19- CD22 CAR T cells after chemotherapy may help to control the disease.
Copanlisib Plus Ibrutinib or Acalabrutinib in R/R CLL
Chronic Lymphocytic Leukemia (CLL)This research study is examining the effect of adding a fixed duration of copanlisib to ibrutinib or acalabrutinib in select participants who have been on ibrutinib or acalabrutinib for at least six months for relapsed/refractory chronic lymphocytic leukemia (CLL). The names of the study drugs involved in this study are: Copanlisib Ibrutinib Acalabrutinib
Anti-CD19 Universal CAR-T Cells for r/r CD19+ B-ALL
B-cell Acute Lymphoblastic LeukemiaB-ALLThis is a single-arm, single-center, open-labeled clinical study to evaluate the safety and efficacy of LstCAR019 injection for patients with relapsed/refractory(r/r) B-cell Acute Lymphoblastic Leukemia(B-ALL).
Study of Sirolimus With PEG-Asparaginase in Acute Lymphoblastic Leukemia (ALL)
Acute Lymphoblastic LeukemiaThe goal of this study is to find a safe dose of sirolimus that can be used with a standard dose of L-asparaginase. To find the safe dose, the investigators will give the first patient a very small dose of sirolimus (smaller than the dose used in organ transplant children) and the standard dose of L-asparaginase. The investigators will then look for side effects. If side effects develop, the investigators will decrease the dose of sirolimus. If they do not, the investigators will increase the dose of sirolimus in the next patient on the study. The investigators will continue this method until fewer than one-third of patients have a side effect that would require stopping the drug or changing the dose. The investigators plan to enroll up to 15 children with relapsed ALL. The enrolled patients must have recovered from other treatment before starting this study. Also, they cannot have severe side effects from their earlier therapy that will possibly make these drugs less safe. The investigators will collect information on whether these drugs help to cure the ALL, but the purpose will be to find a dose of sirolimus that does not cause too many side effects when combined with L-asparaginase. This will be explained to the families and they will sign a written consent. The patients will provide either verbal or written assent when appropriate.