Trial of Genetically Modified T Cells for Children and Young Adults with Difficult-to-Treat CD19+ Leukemia
Sponsor: Seattle Children's Hospital
ClinicalTrials ID:NCT02028455
This study is testing a new treatment using a patient's own T cells, which are modified to target and kill leukemia cells in children and young adults whose leukemia has returned or is resistant to treatment.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This clinical trial is exploring a new treatment for children and young adults with CD19+ leukemia that has come back or is not responding to standard treatments. The treatment involves using the patient's own T cells, which are modified in the lab to recognize and attack leukemia cells. The study aims to find the safest dose and see how well the treatment works. The first phase of the study is for patients who have already had a stem cell transplant, while the second phase is open to all eligible patients.
Description
Participants who meet the study requirements will have their T cells collected through a process called apheresis. If they have had a previous stem cell transplant, the T cells will come from the donor. These T cells are then modified in the lab to target leukemia cells and grown over three weeks. During this time, participants will continue to receive care from their regular doctor and may have additional leukemia treatments.
Once the modified T cells are ready, participants will be assessed to see if they need a treatment to prepare their body for the T cells. After this preparation, they will receive an infusion of the modified T cells. Participants will be closely monitored for two months with regular blood tests and bone marrow checks. After this period, their regular doctor will take over their care, and they may receive more chemotherapy or another stem cell transplant.
Some participants may receive a drug called cetuximab to remove the modified T cells if they experience severe side effects or if they are in remission but have low B cell levels.
After completing the study, participants will have follow-up visits twice a year for five years, and then annually for ten more years. These visits will include medical check-ups and tests to monitor for any long-term effects of the treatment, including the development of new cancers.
Eligibility Criteria
Inclusion Criteria
- Age between 1 and 26 years old.
- Weigh at least 10 kg.
- Have CD19+ leukemia that has returned or is not responding to treatment, or have CD19+ Non-Hodgkin Lymphoma with no other treatment options.
- Have a performance status score of at least 50, indicating they can carry out daily activities with some help.
- Life expectancy of more than 8 weeks.
- No active graft-versus-host disease (GVHD) and off GVHD medication for 4 weeks.
- Recovered from previous cancer treatments.
- At least 7 days since last chemotherapy (except certain types).
- No recent use of systemic steroids (unless for hormone replacement).
- No previous detectable genetically modified cell therapy or virotherapy.
- Normal kidney and liver function tests.
- Adequate heart function and oxygen levels.
- Negative tests for HIV, Hepatitis B, and Hepatitis C.
- No significant brain or nervous system issues.
- Agree to use effective birth control during and for 12 months after treatment.
- Able to undergo the apheresis procedure.
- No other active cancers or severe infections.
- Willing to participate in long-term follow-up for up to 15 years.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital Los Angeles | 90027 | Los Angeles | California |
| Children's Hospital Oakland | 94609 | Oakland | California |
| Seattle Children's Hospital | 98105 | Seattle | Washington |
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