Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program Clinical Trial
— PAVOOfficial title:
Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy
| Verified date | March 2024 |
| Source | Novartis |
| Contact | Novartis Pharmaceuticals |
| Phone | 1-888-669-6682 |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.
| Status | Recruiting |
| Enrollment | 1400 |
| Est. completion date | February 22, 2036 |
| Est. primary completion date | February 22, 2036 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - All patients who have received a CAR-T therapy and completed or discontinued early from a Novartis sponsored treatment protocol that utilized CAR-T cells or from any CAR-T trial sponsored by the University of Pennsylvania with which Novartis has a contractual agreement to co-develop the CAR technology. - Patients who have provided informed consent for the long term follow up study prior to their study participation . Exclusion Criteria: - There are no specific exclusion criteria for this study. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novartis Investigative Site | Camperdown | |
| Australia | Novartis Investigative Site | Melbourne | Victoria |
| Australia | Novartis Investigative Site | Parkville | Victoria |
| Austria | Novartis Investigative Site | Linz | |
| Austria | Novartis Investigative Site | Vienna | |
| Austria | Novartis Investigative Site | Wien | |
| Belgium | Novartis Investigative Site | Gent | |
| Canada | Novartis Investigative Site | Hamilton | Ontario |
| Canada | Novartis Investigative Site | Montreal | Quebec |
| Canada | Novartis Investigative Site | Montreal | Quebec |
| Canada | Novartis Investigative Site | Toronto | Ontario |
| Denmark | Novartis Investigative Site | Copenhagen | |
| Finland | Novartis Investigative Site | Helsinki | |
| France | Novartis Investigative Site | Paris | |
| France | Novartis Investigative Site | Paris 10 | |
| France | Novartis Investigative Site | Pierre Benite | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Frankfurt | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Koeln | |
| Germany | Novartis Investigative Site | Leipzig | |
| Germany | Novartis Investigative Site | Muenchen | |
| Germany | Novartis Investigative Site | Regensburg | Bavaria |
| Germany | Novartis Investigative Site | Ulm | |
| Germany | Novartis Investigative Site | Wuerzburg | |
| Israel | Novartis Investigative Site | Ramat Gan | |
| Israel | Novartis Investigative Site | Tel Aviv | |
| Italy | Novartis Investigative Site | Monza | MB |
| Italy | Novartis Investigative Site | Roma | RM |
| Japan | Novartis Investigative Site | Chuo ku | Tokyo |
| Japan | Novartis Investigative Site | Fukuoka city | Fukuoka |
| Japan | Novartis Investigative Site | Kyoto | |
| Japan | Novartis Investigative Site | Sapporo city | Hokkaido |
| Japan | Novartis Investigative Site | Sendai city | Miyagi |
| Netherlands | Novartis Investigative Site | Amsterdam | |
| Netherlands | Novartis Investigative Site | Utrecht | |
| Netherlands | Novartis Investigative Site | Utrecht | CS |
| Norway | Novartis Investigative Site | Oslo | |
| Norway | Novartis Investigative Site | Oslo | |
| Singapore | Novartis Investigative Site | Singapore | |
| Spain | Novartis Investigative Site | Barcelona | Catalunya |
| Spain | Novartis Investigative Site | Barcelona | |
| Spain | Novartis Investigative Site | Esplugues De Llobregat | Barcelona |
| Spain | Novartis Investigative Site | Hospitalet de LLobregat | Catalunya |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Salamanca | Castilla Y Leon |
| Spain | Novartis Investigative Site | Sevilla | Andalucia |
| Spain | Novartis Investigative Site | Valencia | Comunidad Valenciana |
| Taiwan | Novartis Investigative Site | Taipei | |
| United Kingdom | Novartis Investigative Site | London | |
| United States | University of Michigan . | Ann Arbor | Michigan |
| United States | University of Michigan Health System SC CTL019 | Ann Arbor | Michigan |
| United States | Children's Healthcare of Atlanta SC CTL019 | Atlanta | Georgia |
| United States | Emory University School of Medicine/Winship Cancer Institute | Atlanta | Georgia |
| United States | University of Chicago Medical Center, Hematology & Oncology | Chicago | Illinois |
| United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
| United States | Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State Univ. | Columbus | Ohio |
| United States | UTSW/Children's Medical Center | Dallas | Texas |
| United States | Duke Unversity Medical Center SC - CTL019B2205J | Durham | North Carolina |
| United States | MD Anderson Cancer Center SC | Houston | Texas |
| United States | Children's Mercy Hospital SC | Kansas City | Missouri |
| United States | Childrens Hospital Los Angeles SC CTL019 | Los Angeles | California |
| United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
| United States | University of Minnesota SC-4 | Minneapolis | Minnesota |
| United States | Weill Cornell Medical College | New York | New York |
| United States | The Childrens Hospital of Philadelphia CHOP | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Mayo Clinic Arizona Mayo Clinic Building | Phoenix | Arizona |
| United States | Oregon Health & Science University | Portland | Oregon |
| United States | University of Utah Clinical Trials Office | Salt Lake City | Utah |
| United States | UCSF Medical Center . | San Francisco | California |
| United States | Stanford Universtiy Medical Center SC - CTL019B2205J - B2206 | Stanford | California |
| United States | University of Kansas Cancer Center SC | Westwood | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals | University of Pennsylvania |
United States, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Israel, Italy, Japan, Netherlands, Norway, Singapore, Spain, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of patients with certain events (see description) | The percentage of pts with listed categories: New secondary malignancies, new serious infection, new incidence of serious neurologic disorder, New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, New incidence of a hematologic disorder | at M3 post treatment, M6, M9, M12 and then, every 6M up to year 5, yearly until year 15. | |
| Secondary | Percentage of patients with detectable CAR transgene levels in peripheral blood by q-PCR at pre- specified time points | at M3 post treatment, M6, M9, M12 and every 6M up to year 5, yearly until year 15. | ||
| Secondary | Percentage of patients with detectable RCL by VSV-G | at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15 | ||
| Secondary | Percentage of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry;Incidence of death | at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15. | ||
| Secondary | B- and T- lymphocyte count | at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15. | ||
| Secondary | Height and weight, Tanner staging, menstruation status | at M3 post treatment then M6, M12 and every year until year 15. |