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Hematologic Malignancies clinical trials

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NCT ID: NCT02473757 Enrolling by invitation - Multiple Myeloma Clinical Trials

Gene Therapy Follow-up Protocol for People Previously Enrolled in CAR-T Cell Studies

Start date: September 24, 2015
Phase:
Study type: Observational

Background: - 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.

NCT ID: NCT02315599 Enrolling by invitation - Solid Tumors Clinical Trials

Follow-Up Evaluation for Gene-Therapy-Related Delayed Adverse Events After Participation in Pediatric Oncology Branch Clinical Trials

Start date: December 23, 2014
Phase:
Study type: Observational

Background: - 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.

NCT ID: NCT00596999 Enrolling by invitation - Clinical trials for Hematologic Malignancies

A Single-arm Safety Study of Transplantation Using Umbilical Cord Blood and Human Placental-derived Stem Cells From Partially Matched Related Donors in Persons With Certain Malignant Blood Diseases and Non-malignant Disorders

HPDSC
Start date: May 2007
Phase: Phase 1
Study type: Observational

To investigate the safety of partially matched related human placental-derived stem cells (HPDSC) administered in conjunction with umbilical cord blood (UCB) stem cells from the same donor in subjects with various malignant or nonmalignant disorders potentially curable with stem cell transplantation and to assess potential restoration of normal hematopoiesis and immune function in subjects with these disorders