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NCT01044069 · ClinicalTrials.gov registry record · Phase 1
Precursor B Cell Acute Lymphoblastic Leukemia (B-ALL) Treated With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19
A Phase 1 study of Leukemia and Acute Lymphoblastic Leukemia, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 93
- Enrollment target
- 1
- Study location
NCT01044069 is a Phase 1 study of Leukemia and Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 93 participants, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01044069, a Phase 1 study of Leukemia and Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 93 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is an investigational approach that uses immune cells, called "T cells", to kill leukemia. These T cells are removed from blood, modified in a laboratory, and then put back in the body. T cells fight infections and can also kill cancer cells in some cases. However, right now T cells are unable to kill the cancer cells. For this reason we will put one gene into the T cells that allows them to recognize and kill the leukemia cells. This gene will be put in the T cells by a weakened virus. The gene will produce proteins in the T cells that help the T cells recognize the leukemia cells and possibly kill them. The doctors have found that T cells modified in this way can cure an ALL-like cancer in mice. The main goals of this study is to determine the safety and appropriate dose of these modified T cells in patients with ALL. This will be done in a "clinical trial." The dose of modified T-cells will depend on if you have disease present in your bone marrow or not. The patient will also receive chemotherapy before the T cells. We will use normally chemotherapy that is used in patients with leukemia. The chemotherapy is given to reduce leukemia and to allow the T cells to live longer.
Conditions Studied
Interventions
- BIOLOGICAL gene-modified T cells targeted
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2010-01-05 |
| Est. Completion | 2026-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01044069
The ClinicalTrials.gov registry entry for NCT01044069 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (81% lower). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Leukemia appearing as the primary indexed condition, and to 1 intervention - of which gene-modified T cells targeted is the first listed.
NCT01044069 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01044069 about?
NCT01044069 is a clinical study titled "Precursor B Cell Acute Lymphoblastic Leukemia (B-ALL) Treated With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19". This study is an investigational approach that uses immune cells, called "T cells", to kill leukemia. These T cells are removed from blood, modified in a laboratory, and then put back in the body. T cells fight infections and can also kill cancer cells in some cases. However, right now T cells are u...
What is the current status of trial NCT01044069?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 93 participants. The study started on 2010-01-05. Estimated completion is 2026-01.
What conditions does trial NCT01044069 study?
This clinical trial studies the following conditions: Leukemia, Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT01044069?
The interventions under investigation include: gene-modified T cells targeted (BIOLOGICAL).
Who is sponsoring clinical trial NCT01044069?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01044069 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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