Gene Therapy Follow-up Protocol for People Previously Enrolled in NCI Experimental Transplantation and Immunology Branch Studies
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 8/25/2018 |
| Start Date: | June 13, 2015 |
| End Date: | August 1, 2050 |
Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Experimental Transplantation and Immunology Branch Studies
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
Experimental Transplantation an Immunology 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 Experimental Transplantation and
Immunology 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. Bloodmay 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.
- 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
Experimental Transplantation an Immunology 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 Experimental Transplantation and
Immunology 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
- 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.
Background:
The NCI ETIB Branch conducts clinical trials utilizing gene transfer. The current FDA
requirements for long term follow up may be up to fifteen years for some products. As this
time period is frequently longer than studies are expected to be open, a protocol is
necessary to ensure the necessary follow up of these subjects
Objectives:
To facilitate collection of long term follow up information on subjects who have participated
in gene transfer studies as required by the U.S. Food and Drug Administration and other
regulatory groups
Eligibility:
Enrollment on a NCI ETIB treatment protocol for gene therapy.
Design:
Patients will undergo physical exams, laboratory evaluation or phone follow up as required by
the treatment protocol and/or as clinically indicated.
The NCI ETIB Branch conducts clinical trials utilizing gene transfer. The current FDA
requirements for long term follow up may be up to fifteen years for some products. As this
time period is frequently longer than studies are expected to be open, a protocol is
necessary to ensure the necessary follow up of these subjects
Objectives:
To facilitate collection of long term follow up information on subjects who have participated
in gene transfer studies as required by the U.S. Food and Drug Administration and other
regulatory groups
Eligibility:
Enrollment on a NCI ETIB treatment protocol for gene therapy.
Design:
Patients will undergo physical exams, laboratory evaluation or phone follow up as required by
the treatment protocol and/or as clinically indicated.
- INCLUSION CRITERIA:
- Subjects who have received treatment on an NCI ETIB Branch gene therapy protocol. Age
greater than or equal to 18 years as children are generally excluded from ETIB gene
therapy studies.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 888-624-1937
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