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Retreatment With CTL019/CTL119

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
Email PennCancerTrials@careboxhealth.com Email 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
Email schustes@pennmedicine.upenn.edu Email 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