Protocol Details
Gene Therapy Follow up Protocol for Subjects Previously Enrolled in CAR T-Cell Studies
This study is currently recruiting participants.
Summary
Number | 15-C-0141 |
Sponsoring Institute | National Cancer Institute (NCI) |
Recruitment Detail | Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 18
Max Age: N/A |
Referral Letter Required | Yes |
Population Exclusion(s) | Children |
Keywords | Recombinant DNA Product;
Laboratory Evaluation;
NIH Office of Biotechnology Activities;
Gamma-Retroviral Vectors;
Natural History |
Recruitment Keyword(s) | None |
Condition(s) | Lyphoma, B-Cell;
Leukemia, b-cell;
Multiple Myeloma;
Hematologic Malignancies |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Cancer Institute |
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.
Eligibility
INCLUSION CRITERIA:
-Subjects who have received treatment on a CAR T-cell gene therapy protocol. Age >= 18 years as children are generally excluded from CAR T-cell gene therapy studies.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT02473757Protocol Details
Gene Therapy Follow up Protocol for Subjects Previously Enrolled in CAR T-Cell Studies
This study is currently recruiting participants.
Summary
Number | 15-C-0141 |
Sponsoring Institute | National Cancer Institute (NCI) |
Recruitment Detail | Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 18
Max Age: N/A |
Referral Letter Required | Yes |
Population Exclusion(s) | Children |
Keywords | Recombinant DNA Product;
Laboratory Evaluation;
NIH Office of Biotechnology Activities;
Gamma-Retroviral Vectors;
Natural History |
Recruitment Keyword(s) | None |
Condition(s) | Lyphoma, B-Cell;
Leukemia, b-cell;
Multiple Myeloma;
Hematologic Malignancies |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Cancer Institute |
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.
Eligibility
INCLUSION CRITERIA:
-Subjects who have received treatment on a CAR T-cell gene therapy protocol. Age >= 18 years as children are generally excluded from CAR T-cell gene therapy studies.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT02473757