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NCT02315612 · ClinicalTrials.gov registry record · Phase 1
Anti-CD22 Chimeric Receptor T Cells in Pediatric and Young Adults With Recurrent or Refractory CD22-expressing B Cell Malignancies
A Phase 1 study of Acute Lymphoblastic Leukemia and Follicular Lymphoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 134
- Enrollment target
- 1
- Study location
NCT02315612: Completed Phase 1 study of Acute Lymphoblastic Leukemia and Follicular Lymphoma, sponsored by National Cancer Institute (NCI).
NCT02315612 is a Phase 1 study of Acute Lymphoblastic Leukemia and Follicular Lymphoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 134 participants, below the 381-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02315612, a Phase 1 study of Acute Lymphoblastic Leukemia and Follicular Lymphoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 134 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- One type of cancer therapy takes blood cells from a person, changes them in a lab, then gives the cells back to the person. In this study, researchers are using an anti-CD22 gene, a virus, and an immune receptor to change the cells. Objective: \- To see if giving anti-CD22 Chimeric Antigen Receptor (CAR) cells to young people with certain cancers is safe and effective. Eligibility: \- People ages 1-39 with a leukemia or lymphoma that has not been cured by standard therapy. Design: * Participants will be screened to ensure their cancer cells express the CD22 protein. They will also have medical history, physical exam, blood and urine tests, heart tests, scans, and x-rays. They may give spinal fluid or have bone marrow tests. * Participants may have eye and neurologic exams. * Participants will get a central venous catheter or a catheter in a large vein. * Participants will have white blood cells removed. Blood is removed through a needle in an arm. White blood cells are removed. The rest of the blood is returned by needle in the other arm. * The cells will be changed in a laboratory. * Participants will get two IV chemotherapy drugs over 4 days. Some will stay in the hospital for this. * All participants will be in the hospital to get anti-CD22 CAR cells through IV. They will stay until any bad side effects are gone. * Participants will have many blood tests. They may repeat some screening exams. * Participants will have monthly visits for 2-3 months, then every 3-6 months. They may repeat some screening exams. * Participants will have follow-up for 15 years.
Primary Outcome
Number of patients who have grade 3 CRS and above
Conditions Studied
Interventions
- BIOLOGICAL CD22-CAR
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2014-12-12 |
| Est. Completion | 2024-10-29 |
| Phase | Phase 1 |
What the finished NCT02315612 record still lists
NCT02315612 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 381-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (65% lower).
The record links to 10 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which CD22-CAR is the first listed.
NCT02315612 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02315612 about?
NCT02315612 is a clinical study titled "Anti-CD22 Chimeric Receptor T Cells in Pediatric and Young Adults With Recurrent or Refractory CD22-expressing B Cell Malignancies". Background: \- One type of cancer therapy takes blood cells from a person, changes them in a lab, then gives the cells back to the person. In this study, researchers are using an anti-CD22 gene, a virus, and an immune receptor to change the cells. Objective: \- To see if giving anti-CD22 Chimeric...
What is the current status of trial NCT02315612?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 134 participants. The study started on 2014-12-12. Estimated completion is 2024-10-29.
What conditions does trial NCT02315612 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Follicular Lymphoma, Acute Lymphocytic Leukemia, ALL, NHL.
What interventions are being tested in trial NCT02315612?
The interventions under investigation include: CD22-CAR (BIOLOGICAL).
Who is sponsoring clinical trial NCT02315612?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02315612 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02315612's enrollment target sits among peer trials
134 39th of 131 higher than 93 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lymphoblastic Leukemia 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.
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