Study Stopped
Administrative Reasons
Allo CART-19 Protocol
Pilot Study of Donor Lymphocyte Infusions Using Donor T Cells Engineered to Contain Anti-CD19 Attached To TCR And 4-1BB Signaling Domains in Patients With Relapsed CD19+ All After Allogeneic Stem Cell Transplantation
1 other identifier
interventional
2
1 country
1
Brief Summary
The primary objective is to determine the safety and survival of the redirected allogeneic T cells transduced with the anti-CD19 lentiviral vector (referred to as CART-19 cells).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2010
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 8, 2012
CompletedFirst Posted
Study publicly available on registry
March 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 9, 2020
July 1, 2020
4.7 years
March 8, 2012
July 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Adverse Events
26 months
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- CD19+ ALL relapsed after allogeneic SCT.
- No active GVHD and off immunosuppression for greater than or equal to 4 weeks.
- Age greater than or equal to 18 years.
- Creatinine less than or equal to2.5 mg/dl.
- ALT/AST less than or equal to3x normal
- Bilirubin less than or equal to2.0 mg/dl
- Donor is available and is able to undergo apheresis. A separate donor consent process and form is described below.
- Voluntary informed consent is given.
You may not qualify if:
- Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection.
- Previously treatment with any gene therapy products.
- Feasibility assessment during screening demonstrates less than 30% transduction of target lymphocytes, or insufficient expansion ( less than 5-fold) in response to CD3/CD28 costimulation..
- Any uncontrolled active medical disorder that would preclude participation as outlined.
- HIV infection.
- Patients with active CNS involvement with leukemia. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was greater than or equal to 4 weeks before enrollment
- Patients with active GVHD or requiring immune suppression.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Porter, MD
Abramson Cancer Center at Penn Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2012
First Posted
March 12, 2012
Study Start
September 1, 2010
Primary Completion
May 1, 2015
Study Completion
June 1, 2016
Last Updated
July 9, 2020
Record last verified: 2020-07