Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia

Hematologic Neoplasms

Leukemia, B-Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Leukemia, Lymphoid

Lymphatic Diseases

Subjects who have received treatment on an NCI Surgery Branch CAR T-cell gene therapy protocols.

James N Kochenderfer, M.D.

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.

Background:

-The National Cancer Institute Surgery Branch (NCI-SB) Branch investigator conducts clinical trials utilizing gene transfer. The current U.S. Food and Drug Administration (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 long-term follow-up protocol is necessary to ensure the 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 CAR T-cell 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.

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

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

List of long time adverse event frequency after Gene therapy drug

National Cancer Institute (NCI)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Uterine Cervical Neoplasms

Oropharyngeal Neoplasms

Squamous Intraepithelial Lesions of the Cervix

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Cervical Intraepithelial Neoplasia

Subjects who have received treatment on an NCI CIO or CIO gene therapy protocol.

Observation/ Gene Therapy Long-term Follow-up. Subjects who have received treatment on an applicable NCI CIO gene therapy protocol.

GeneTherapy

Scott M Norberg, D.O.

Background:

Gene therapy is closely followed by the U.S. Food and Drug Administration (FDA). The FDA requires researchers to conduct long-term follow-up of people who have had the treatment. This study collects data on people who have had gene therapy and sends it to the FDA. The data does not include participants names.

Objective:

To contact current or past participants of gene therapy protocols at least once a year for up to 15 years to ensure they have not had any harmful side effects.

Eligibility:

People aged 18 and older who have had gene therapy in a National Cancer Institute study

Design:

Participants will give their address and telephone number. They will also give and the address and phone number of 1 or 2 other people who will know where they are.

For the first year after gene therapy, participants will give blood samples 3 times (at 3, 6, and 12 months). For the next 4 years, they may have a physical exam and laboratory tests with a home physician. They will get a kit to mail in blood samples. Or they can visit the NIH Clinical Center. They will be asked if they have had any signs of neurological, autoimmune, or blood disorders, or any new cancers.

For years 6 to 15, participants will be contacted yearly via phone or email and asked questions about their health. They may give blood samples.

When the participant dies, if researchers think the death was caused by gene therapy, they will ask the participant s family to allow an autopsy.

...

Background:

The NCI CIO 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 CIO treatment protocol for gene therapy.

Design:

Patients will undergo physical exams, laboratory evaluations and/or phone follow up as required by the treatment protocol and/or as clinically indicated.

Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gene Therapy Follow-up Protocol for People Previously Enrolled in CAR-T Cell Studies	NCT02473757	Lyphoma, B-Cell Leukemia, B-cel... Multiple Myelom... Hematologic Mal...		18 Years -	National Institutes of Health Clinical Center (CC)
Gene Therapy Follow-up Protocol for People Previously Enrolled in CAR-T Cell Studies	NCT02473757	Lyphoma, B-Cell Leukemia, B-cel... Multiple Myelom... Hematologic Mal...		18 Years -	National Institutes of Health Clinical Center (CC)
Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies	NCT04266093	Cervical Intrae... Cervical Neopla... Oropharyngeal N... Squamous Intrae... Hematologic Mal...	GeneTherapy	18 Years - 120 Years	National Institutes of Health Clinical Center (CC)

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