Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01029366 · ClinicalTrials.gov registry record · Phase 1
CART19 to Treat B-Cell Leukemia or Lymphoma That Are Resistant or Refractory to Chemotherapy
A Phase 1 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT01029366: Completed Phase 1 study, sponsored by University of Pennsylvania.
NCT01029366 is a Phase 1 study that has completed, run by University of Pennsylvania. The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01029366, a Phase 1 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This is a Pilot/Phase I, single arm, single center, open label study to determine the safety, efficacy and cellular kinetics of CART19 (CTL019) in chemotherapy resistant or refractory CD19+ leukemia and lymphoma subjects. The study consists of three Phases: 1\) a Screening Phase, followed by 2) an Intervention/Treatment Phase consisting of apheresis, lymphodepleting chemotherapy (determined by the Investigator and based on subject's disease burden and histology, as well as on the prior chemotherapy history received), infusions of CTL019, tumor collection by bone marrow aspiration or lymph node biopsy (optional, depending on availability), and 3) a Follow-up Phase. The suitability of subjects' T cells for CTL019 manufacturing was determined at study entry. Subjects with adequate T cells were leukapheresed to obtain large numbers of peripheral blood mononuclear cells for CTL019 manufacturing. The T cells were purified from the peripheral blood mononuclear cells, transduced with TCR-ζ/4-1BB lentiviral vector, expanded in vitro and then frozen for future administration. The number of subjects who had inadequate T cell collections, expansion or manufacturing compared to the number of subjects who had T cells successfully manufactured is a primary measure of feasibility of this study. Unless contraindicated and medically not advisable based on previous chemotherapy, subjects were given conditioning chemotherapy prior to CTL019 infusion. The chemotherapy was completed 1 to 4 days before the planned infusion of the first dose of CTL019. Up to 20 evaluable subjects with CD19+ leukemia or lymphoma were planned to be dosed with CTL019. A single dose of CTL019 (consisting of approximately 5x10\^9 total cells, with a minimal acceptable dose for infusion of 1.5x10\^7 CTL019 cells) was to be given to subjects as fractions (10%, 30% and 60% of the total dose) on Day 0, 1 and 2. A second 100% dose of CTL019 was initially permitted to be given on Day 11 to 14 to subjects, provid
Interventions
- BIOLOGICAL CART-19
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2010-03-17 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01029366
The ClinicalTrials.gov registry entry for NCT01029366 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CART-19 is the first listed.
NCT01029366 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01029366 about?
NCT01029366 is a clinical study titled "CART19 to Treat B-Cell Leukemia or Lymphoma That Are Resistant or Refractory to Chemotherapy". This is a Pilot/Phase I, single arm, single center, open label study to determine the safety, efficacy and cellular kinetics of CART19 (CTL019) in chemotherapy resistant or refractory CD19+ leukemia and lymphoma subjects. The study consists of three Phases: 1\) a Screening Phase, followed by 2) an ...
What is the current status of trial NCT01029366?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2010-03-17. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01029366?
The interventions under investigation include: CART-19 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01029366?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.