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MinorEligibility criteria expanded, about 32 wordsSite details revised at 2 of 2 sites · Publications: details revised at 1 of 1 entryShow 2 more changesShow less
Site details revised at 2 of 2 sites
Publications: details revised at 1 of 1 entry
NotablePrimary completion date: Apr 2026 to Apr 2027v19
MinorStudy description expanded, about 16 wordsEligibility criteria expanded, about 2 wordsv18Show 1 more changeShow less
Minor2 versionsRe-verified since Feb 26, 2024, no change to tracked fieldsv16-v17
MinorCompletion date: Feb 2036 to Feb 2040Interventions: CAR T Cells (Genetic), Cyclophosphamide (Drug), Fludarabine (Drug) to CAR T Cells (Genetic) · Study description shortened, about 75 wordsv15Show 2 more changesShow less
Interventions: CAR T Cells (Genetic), Cyclophosphamide (Drug), Fludarabine (Drug) to CAR T Cells (Genetic)
NotablePrimary completion date: Apr 2021 to Apr 2022v11
Minor2 versionsRe-verified since Jan 31, 2020, no change to tracked fieldsv9-v10
NotableEnrollment target: 18 to 66Primary completion date: Apr 2020 to Apr 2021 · Completion date: Feb 2035 to Feb 2036v8Show 2 more changesShow less
Primary completion date: Apr 2020 to Apr 2021
Completion date: Feb 2035 to Feb 2036
MinorStudy description expanded, about 75 wordsSite contacts updated at 2 of 2 sites · Eligibility criteria shortened, about 1 wordv7Show 2 more changesShow less
NotableTrial status: Not Yet Recruiting to RecruitingStart date changed from estimate of May 2017 to May 8, 2017 · Secondary endpoints: details revised at 2 of 3 entries · Site details revised at 2 of 2 sites · 1 morev5Show 4 more changesShow less
Start date changed from estimate of May 2017 to May 8, 2017
Secondary endpoints: details revised at 2 of 3 entries
NotableStart date: Feb 2017 to May 2017Enrollment target: 14 to 18 · Eligibility criteria expanded, about 75 words · Secondary endpoints: details revised at 2 of 3 entries · 2 morev4Show 5 more changesShow less
Enrollment target: 14 to 18
Eligibility criteria expanded, about 75 words
Secondary endpoints: details revised at 2 of 3 entries
NotableStart date: Nov 2016 to Feb 2017Primary completion date: Jan 2020 to Apr 2020 · Completion date: Nov 2034 to Feb 2035v3Show 2 more changesShow less
Primary completion date: Jan 2020 to Apr 2020
Completion date: Nov 2034 to Feb 2035
MinorSecondary endpoints: details revised at 1 of 3 entriesStudy description expanded, about 1 wordv2Show 1 more changeShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The subject has a type of lymph gland cancer called Lymphoma.
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected with germs. Both antibodies and T cells have been used to treat patients with cancers; they both have shown promise, but have not been strong enough to cure most patients. Investigators hope that both will work better together.
Investigators have found from previous research that they can put a new gene into T cells that will make them recognize cancer cells and kill them. They now want to test whether these genetically modified T cells given after chemotherapy will be more effective at killing cancer cells.
The gene that will be put into the T cells makes an antibody called anti-CD30. This antibody sticks to lymphoma cells because of a substance on the outside of the cells called CD30. Anti-CD30 antibodies have been used to treat people with lymphoma, but have not been strong enough to cure most patients.
For this study, the anti-CD30 antibody has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD30 chimeric receptor-activated T cells (CD30.CAR T cells) seem to kill some of the tumor, but they don't last very long and so their chances of fighting the cancer are unknown.
Several studies suggest that the infused T cells need room to be able to multiply and grow to accomplish their functions, and that this may not happen if there are too many other T cells in circulation. Because of that, doctors may use chemotherapy drugs to decrease the level of circulating T cells prior to the CD30.CAR T cells infusion. This is called "lymphodepletion"
CD30.CAR T cells have previously been studied in lymphoma patients.