Trials / Withdrawn
WithdrawnNCT02167360
Study of Efficacy and Safety of CTL019 in Adult ALL Patients
A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Adult Patients With Relapsed and Refractory B-cell Acute Lymphoblastic Leukemia
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Abramson Cancer Center at Penn Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of CTL019 in adult patients with r/r B-cell ALL. The study will have the following sequential phases: Screening, Pre-Treatment, Treatment and Primary Follow-up, Secondary Follow-up (Relapse Follow-up) and Survival Follow-up. The total duration of the primary follow-up is 1 year from cell infusion. Safety will be assessed until the end of the treatment and primary follow-up phase.
Conditions
- B-cell Acute Lymphoblastic Leukemia
- Relapsed B-cell Acute Lymphoblastic Leukemia
- Refractory B-cell Acute Lymphoblastic Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CTL019 | A dose of CTL019 transduced cells will consist of a single infusion of 2 to 10 x 108 CTL019 transduced cells. |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2017-01-11
- First posted
- 2014-06-19
- Last updated
- 2017-02-14
Source: ClinicalTrials.gov record NCT02167360. Inclusion in this directory is not an endorsement.