Studies
Study First Submitted Date | 2020-05-28 |
Study First Posted Date | 2020-06-09 |
Last Update Posted Date | 2023-06-22 |
Start Month Year | May 2024 |
Primary Completion Month Year | July 2027 |
Verification Month Year | June 2023 |
Verification Date | 2023-06-30 |
Last Update Posted Date | 2023-06-22 |
Detailed Descriptions
Sequence: | 20777460 |
Description | This is a single arm open label trial that will assess the safety and efficacy of retreatment with CTL019/CTL119 chimeric antigen receptor (CAR) modified T cells in patients who have late relapse of diffuse large B-cell or follicular lymphoma after achieving complete remission from prior CTL019/CTL119 treatment. Patients eligible for this protocol will have been treated initially with CTL019/CTL119 under UPCC13413/NCT02030834, have experienced a durable complete response (defined as ≥ 6 months duration), and have a residual manufactured CTL019/CTL119 product available. This protocol will serve subjects with no available potentially curative treatment options (such as autologous or allogeneic stem cell transplantation) who have a limited prognosis (months to < 2 year expected survival) with available therapies. |
Facilities
Sequence: | 200571273 |
Name | University of Pennsylvania |
City | Philadelphia |
State | Pennsylvania |
Zip | 19104 |
Country | United States |
Facility Contacts
Sequence: | 28175566 | Sequence: | 28175567 |
Facility Id | 200571273 | Facility Id | 200571273 |
Contact Type | primary | Contact Type | backup |
Name | Stephen J Schuster, MD | Name | Emerging Medicine |
PennCancerTrials@careboxhealth.com | PennCancerTrials@careboxhealth.com | ||
Phone | 855-216-0098 | Phone | 855-216-0098 |
Browse Interventions
Sequence: | 96276402 | Sequence: | 96276403 | Sequence: | 96276404 |
Mesh Term | Tisagenlecleucel | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Antineoplastic Agents |
Downcase Mesh Term | tisagenlecleucel | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | antineoplastic agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52314111 |
Name | Lymphoma, B-Cell |
Downcase Name | lymphoma, b-cell |
Id Information
Sequence: | 40260991 | Sequence: | 40260992 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | UPCC 40419 | Id Value | 834286 |
Id Type | Other Identifier | ||
Id Type Description | University of Pennsylvania Institutional Review Board | ||
Countries
Sequence: | 42680368 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55752498 |
Group Type | Experimental |
Title | Retreatment with CTL019/CTL119 |
Description | All subjects will receive retreatment with CTL019/CTL119 and be followed per the schedule of procedures. |
Interventions
Sequence: | 52625417 |
Intervention Type | Drug |
Name | CD19 redirected autologous T cells (CTL019 or CTL119 cells) |
Description | Retreatment with CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19 cells) or huCD19-directed Chimeric Antigen Receptor-modified T Cells (huCART19 cells) in subjects with late relapse of B-cell lymphomas. |
Keywords
Sequence: | 80066838 | Sequence: | 80066839 | Sequence: | 80066840 | Sequence: | 80066841 |
Name | CTL019 | Name | CTL119 | Name | CAR T-cell | Name | CART |
Downcase Name | ctl019 | Downcase Name | ctl119 | Downcase Name | car t-cell | Downcase Name | cart |
Design Outcomes
Sequence: | 177907050 | Sequence: | 177907051 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Measure | Overall response rate using Cheson 2007 criteria |
Time Frame | At time of consent through 1 year after the subject received CTL019/CTL119 | Time Frame | Month 3 post-infusion |
Description | Safety of retreatment with CTL019/CTL119 as measured by treatment-related events | Description | Efficacy of retreatment with CTL019/CTL119 as measured by ORR by Cheson 2007 definitions at 3 months |
Browse Conditions
Sequence: | 194031061 | Sequence: | 194031062 | Sequence: | 194031063 | Sequence: | 194031064 | Sequence: | 194031065 | Sequence: | 194031066 | Sequence: | 194031067 | Sequence: | 194031068 | Sequence: | 194031069 |
Mesh Term | Lymphoma | Mesh Term | Lymphoma, B-Cell | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Lymphoproliferative Disorders | Mesh Term | Lymphatic Diseases | Mesh Term | Immunoproliferative Disorders | Mesh Term | Immune System Diseases | Mesh Term | Lymphoma, Non-Hodgkin |
Downcase Mesh Term | lymphoma | Downcase Mesh Term | lymphoma, b-cell | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lymphoproliferative disorders | Downcase Mesh Term | lymphatic diseases | Downcase Mesh Term | immunoproliferative disorders | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | lymphoma, non-hodgkin |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48453047 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Pennsylvania |
Overall Officials
Sequence: | 29361574 |
Role | Principal Investigator |
Name | Stephen J Schuster |
Affiliation | University of Pennsylvania |
Central Contacts
Sequence: | 12044139 | Sequence: | 12044140 |
Contact Type | primary | Contact Type | backup |
Name | Stephen J Schuster, MD | Name | Emerging Medicine |
Phone | 215.614.1846 | Phone | 855-216-0098 |
schustes@pennmedicine.upenn.edu | PennCancerTrials@careboxhealth.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68341970 |
Design Group Id | 55752498 |
Intervention Id | 52625417 |
Eligibilities
Sequence: | 30848196 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria: Diffuse Large B-Cell Lymphoma or Follicular lymphoma, previously identified as CD19+ Previously treated on UPCC13413/ NCT02030834 with CTL019/CTL119, with historical manufactured product available at Penn for reinfusion Previous complete response to CAR T-cells with a duration ≥ 6 months (defined as 168 days) No available curative treatment options (such as autologous or allogeneic HSCT) with limited prognosis (several months to < 2 year survival) with currently available therapies. Age ≥18 years Creatinine < 1.6 mg/dL ALT/AST < 3x upper limit of normal Bilirubin < 2.0 mg/dL, unless subject has Gilbert’s Syndrome (≤3.0 mg/dL) Measurable or assessable disease according to the “Revised Response Criteria for Malignant Lymphoma” (Cheson et al., J. Clin. Onc., 2007)88. Patients in complete remission with no evidence of disease are not eligible. Performance status (ECOG) 0 or 1. Left Ventricle Ejection Fraction (LVEF) > 40% confirmed by ECHO/MUGA Agree to contraceptive requirements outlined in Section 4.3. Provide written informed consent. Exclusion Criteria: Uncontrolled active infection. Active hepatitis B or hepatitis C infection. Any uncontrolled active medical disorder that would preclude participation as outlined. Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 1). HIV infection. Patients with active CNS involvement by malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254217060 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2020 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30594055 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28960528 |
Responsible Party Type | Sponsor |