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NCT01593696 · ClinicalTrials.gov registry record · Phase 1
Anti-CD19 White Blood Cells for Children and Young Adults With B Cell Leukemia or Lymphoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
NCT01593696: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01593696 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 53 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01593696, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
Study Summary
Background: \- Although progress has been made in treating children with B-cell cancers such as leukemia or lymphoma, many children do not respond to the standard treatments. One possible treatment involves collecting white blood cells called T cells from the person with cancer and modifying the cells to attack the B-cell cancer. The cells can then be given back to the participant. This study will use T cells that have been modified to attack the cluster of differentiation 19 (CD19) protein, which is found on the surface of some B-cell cancers. Objectives: \- To see if anti-CD19 modified white blood cells are a safe and effective treatment for children and young adults with advanced B-cell cancer. Eligibility: * Children and young adults between 1 and 30 years of age who have B-cell cancer (leukemia or lymphoma) that has not responded to standard treatments. * The leukemia or the lymphoma must have the CD19 protein. * There must be adequate organ function. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies or bone marrow biopsies may be performed depending on the type of cancer. * Participants will undergo a process where white blood cells are collected, called apheresis. These cells will be modified to contain the anti-CD19 gene. * Participants will have 3 days of chemotherapy to prepare their immune system to accept the modified cells. * Participants will receive an infusion of their own modified white blood cells. They will remain in the hospital until they have recovered from the treatment. * Participants will have frequent follow-up visits to monitor the outcome of the treatment. * If the participant benefits from the treatment, then he/she may have the option for another round of treatment.
Primary Outcome
Participants with B cell malignancies who received preparative chemotherapy followed by CD19 CAR T-cells with \< Grade 4 cytokine release syndrome.
Interventions
- BIOLOGICAL Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2012-06-29 |
| Est. Completion | 2017-10-02 |
| Phase | Phase 1 |
What the finished NCT01593696 record still lists
NCT01593696 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 1 intervention - of which Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR) is the first listed.
NCT01593696 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01593696 about?
NCT01593696 is a clinical study titled "Anti-CD19 White Blood Cells for Children and Young Adults With B Cell Leukemia or Lymphoma". Background: \- Although progress has been made in treating children with B-cell cancers such as leukemia or lymphoma, many children do not respond to the standard treatments. One possible treatment involves collecting white blood cells called T cells from the person with cancer and modifying the ce...
What is the current status of trial NCT01593696?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2012-06-29. Estimated completion is 2017-10-02.
What interventions are being tested in trial NCT01593696?
The interventions under investigation include: Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01593696?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01593696's enrollment target sits among peer trials
53 948th of 2000 higher than 1,045 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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