Gene Therapy Follow-up Protocol for People Previously Enrolled in CAR-T Cell Studies
LyphomaB-Cell4 moreBackground: - Gene therapy is a way to treat or prevent disease using genes. It is monitored very closely by regulators because there can be long-term, unexpected side effects. NIH is required to try to contact people who have been treated with gene therapy at least annually for up to 15 years. This is to see if they have had any bad side effects. This trial does not include any therapy and is only for patients previously treated on gene-therapy trials at the NCI Surgery Branch who are no longer enrolled on their original gene therapy clinical trial. Objective: - To collect of long-term follow-up data on people who have been in gene transfer studies. This follow-up is required by regulators. Eligibility: - People age 18 and older who have been in a previous NCI Surgery Branch gene therapy research study. Design: After they get the genetically modified cells, participants will: Have blood drawn 3, 6, and 12 months later. Have an annual clinic visit for the next 4 years. They will have a physical exam. They will answer questions about any signs of neurological, autoimmune, or blood disorders, or any new cancers. Blood may be drawn. Be called or emailed annually for the next 10 years. They will answer health questions. Blood samples may need to be taken. Participants will be asked for their current address and phone number. They will also be asked for the address and phone number of 1 or 2 people who will know their whereabouts. One of these should be a family member if possible, At the time of the participant s death, researchers will request permission from their family for an autopsy.
Individual Dietary Counseling Based on Taste-tests in Patients With Hematological Cancer in Cytostatic...
Hematological MalignancyThe purpose of the study is to investigate whether a simple taste-test will increase the intake of energy as part of the individual dietary counseling.
REINFORCED PROPHYLAXIS OF GVH IN ELDERLY PATIENTS WITH HAEMATOLOGICAL MALIGNANCIES RECEIVING HAPLOIDENTICAL...
Hematological MalignancyThe aim of this trial is to evaluate the efficacy of GVH prophylaxis reinforced by low-dose Thymoglobulin administered at the end of aplasia after haploidentical allogeneic transplantation. Patients will receive a single infusion of Thymoglobulin at a dose of 1 mg/kg between 48h and 72h after emergence from aplasia, and will be followed for 12 months.
Study of KB004 in Subjects With Hematologic Malignancies (Myelodysplastic Syndrome, MDS, Myelofibrosis,...
Myelodysplastic Syndrome (MDS)Myelofibrosis (MF)This is a global, multicenter, open-label, repeat-dose, Phase 1/2 study consisting of a Dose Escalation Phase (Phase 1) and a Cohort Expansion Phase (Phase 2). In both phases, KB004 will be administered by IV infusion once weekly as part of a 21-day dosing cycle.
Follow-Up Evaluation for Gene-Therapy-Related Delayed Adverse Events After Participation in Pediatric...
Pediatric CancersHematologic Malignancies1 moreBackground: - Gene therapy involves changing the genes inside the body s cells to stop disease. It is very closely regulated. People who have had this therapy may have problems months or even years later. Researchers do not know the long-term side effects, so they want to study people who have had the therapy. They want the study to continue over the next 15 years. Objective: - To study over time the negative side effects from genetically engineered cellular therapy. This will be studied in people who have been in Pediatric Oncology Branch (POB) gene therapy trials. Eligibility: - People who are currently or were previously in a research study with gene therapy in the National Cancer Institute POB. Design: Participants blood will be tested right before they get the genetically changed cells. They will get the cells as part of another study. For the next year, they will come back to the clinic or see their doctor at home at least every 3 months. They will answer questions about their health and blood will be drawn. For the next 5 years, they will go to the clinic or see their own doctor once a year. They will have physical exam and blood will be drawn. For 10 years after that, they will be asked every year for health information. Participants will keep their contact information up to date with researchers. They may be phoned for more health information. If the participant was under 18 years old when given the gene therapy and turns 18 during this follow-up, they will be asked to sign a new consent form when they turn 18.
Safety, Tolerability and Pharmacokinetics/Pharmacodynamics (PK/PD) of SHR-1603 in Subjects With...
Physiological Effects of DrugsNeoplasms by Histologic Type4 moreSHR-1603-I-101 is an single-arm, open-label, dose finding phase I clinical trial of SHR-1603 in subjects with advanced solid tumor or relapsed/refractory malignant lymphoid diseases. The study drug will be administered by intravenous infusion.
CB-Long-Term Safety Study (CB-LTSS)
LymphomaNon-Hodgkin7 moreThis is a non-interventional, long-term safety study of allogeneic CAR-T cell therapy in patients with hematologic malignancies. Its purpose of is to collect long-term observational data to identify and understand potential late side effects in patients who have received CAR-T cell therapies.
Cancer and Aging Resilience Evaluation in Older Adults With Hematologic Malignancies: The CARE-Heme...
Multiple MyelomaAmyloidosis1 moreThe primary purpose of this protocol is to create a registry of older (≥50 years old) patients with Hematologic Malignancies. Our main objectives include: To understand the prevalence of frailty and geriatric impairments among patients aged ≥50y and above diagnosed with a hematologic malignancy at UAB and to gather information that would lend support for future research in this vulnerable population.
A Study of Haploidentical Bone Marrow Transplant for Patients With Hematologic Malignancies
Hematologic MalignanciesThe primary objective is to determine overall survival 180 days after transplantation involving HLA-haploidentical stem cell/bone marrow graft, and post-transplant Cy.
Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic...
LeukemiaAcute1 moreThe purpose of this research study is to determine if frailty assessments can be used to predict how well patients aged 60 years and older will do after chemotherapy, CAR T-cell therapy, or allogeneic stem cell transplant.