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CAR T-cell Therapy

CAR T-Cell Therapy for Acute Lymphoblastic Leukemia

Phase 1

Waitlist Available

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Absolute lymphocyte count of >/=750 cell/mm3 or >/=500 is >20kg

CD19+ Leukemia in 1st marrow relapse with MRD at the end of 1st month of re-induction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 days

Awards & highlights

Study Summary

This trial is testing a new leukemia treatment where the patient's own T cells are modified to kill leukemia cells.

Who is the study for?

This trial is for children and young adults aged 1-26 with CD19+ Leukemia that's relapsed multiple times. Participants must have a certain level of physical fitness, adequate organ function, no severe infections or other health conditions that could interfere with the treatment, and not be pregnant. They should also agree to long-term follow-up.Check my eligibility

What is being tested?

The study tests genetically modified T cells designed to attack leukemia by recognizing a protein called CD19 on cancer cells. It aims to find the highest safe dose of these CAR+ T cells and assess their toxicity as well as effectiveness in treating leukemia.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever, fatigue, difficulty breathing, changes in blood pressure or heart rate; there might also be risks associated with cell therapy like anemia or infection due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphocyte count is high enough for the trial.

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My leukemia has returned and shows specific markers after initial treatment.

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My leukemia has returned at least twice and tests positive for CD19.

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I have CD19+ leukemia and need a stem cell transplant but cannot have one.

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I am between 1 and 26 years old.

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I am able to live my life with some help or independently.

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I have recovered from the side effects of my previous cancer treatments.

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My kidney function tests are within normal range for my age and gender.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~42 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participant with Adverse Events

Secondary outcome measures

Determine if there is anti-leukemic activity of the CD19 CAR+ T cells

Persistence of the CD19 CAR+ T cells

Trial Design

1Treatment groups

Experimental Treatment

Group I: CAR+ T cellsExperimental Treatment1 Intervention

Subjects will receive two days of cyclophosphamide for a total of 3g/m^2 followed several days later by a single dose of Autologous CD19 CAR+ EGFTt + T cells

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

301 Previous Clinical Trials

5,216,971 Total Patients Enrolled

Rebecca Gardner, MDStudy ChairSeattle Children's Hospital

2 Previous Clinical Trials

245 Total Patients Enrolled

Media Library

Autologous CD19 CAR+ EGFTt + T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01683279 — Phase 1

B-Cell Leukemia Research Study Groups: CAR+ T cells

B-Cell Leukemia Clinical Trial 2023: Autologous CD19 CAR+ EGFTt + T cells Highlights & Side Effects. Trial Name: NCT01683279 — Phase 1

Autologous CD19 CAR+ EGFTt + T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01683279 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical research still open to participants?

"As per the information provided on clinicaltrials.gov, this particular study is not presently enrolling patients. Although it was initially posted in March 2012 and last updated February 2022, 1556 other trials are actively recruiting at present."

Answered by AI

Has the Autologous CD19 CAR+ EGFTt + T cells regimen gained approval from the FDA?

"Assessing safety, our team at Power has assigned Autologous CD19 CAR+ EGFTt + T cells a score of 1 as it is currently in its first clinical trial phase and lacks substantial evidence for efficacy and safety."

Answered by AI

Is it possible for me to join this medical experiment?

"For this trial, 6 participants with leukemia or lymphoid aged 1 to 26 are sought. Aspiring applicants must fulfil the following requirements: CD19+ Leukemia in first relapse of marrow; capacity to endure a draw of 4-6mL/kg of blood; ANCs (absolute lymphocyte counts) >750 cell/mm3 (>500 if body weight exceeds 20 kg); indications for HCT but contraindicated; KPS and LKS scores both above 50; life expectancy greater than 12 weeks post recruitment; recovered from prior chemotherapy, immunotherapy or radiotherapies’ adverse effects; creatinine clearance rate over"

Answered by AI

Is this study open to participants of age 25 and above?

"The requirements for this clinical trial stipulate that applicants must be between 1 and 26 years of age. For patients younger than 18, there are 468 studies available while those over 65 have access to 1249 separate trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Pediatric Trial of Genetically Modified Autologous T Cells Directed Against CD19 for Relapsed CD19+ Acute Lymphoblastic Leukemia

Colleen Annesley 2012. "A Pediatric Trial of Genetically Modified Autologous T Cells Directed Against CD19 for Relapsed CD19+ Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01683279.

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