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Monday, January 9, 2012

Frequently Asked Questions About the CAR T-19 Study

The results from a Penn clinical trial using genetically modified T cells to target a molecule on chronic lymphocytic leukemia (CLL) cells, prompted many patients and physicians to ask for information about enrolling in the study. This trial has been referred to as the “CART-19 cell" (chimeric antigen receptor T Cells against CD19) trial.

Only a few participants were included in the first phase of the trial, and Penn researchers are currently enrolling a small number of additional participants for the next phase of this trial.

Below are frequently asked questions about the trial.

Is the trial currently enrolling participants?

The trial is currently treating another small group of patients but has limited availability.

Follow this blog or check our website from time to time, where you will find updates about our research on genetically modified T cells (CAR T-19).

How does this trial work?

The CAR T Cells Trial uses genetically modified T cells to treat patients with B cell Chronic Lymphocytic Leukemia (CLL) and other B cell malignancies.  A patients own immune cells (T cells) are removed from the blood and genetically modified in the laboratory by infecting them with a virus.  This modification allows them to potentially target and kill their own CLL cells.The modified cells (CART-19 cells) are then grown in the laboratory and re-infused into patients.

Who are suitable candidates for this trial?

This phase I clinical trial is designed for patients with documented CD19 positive leukemia or lymphoma. For example, patients who have one of the following:
  • Acute lymphoblastic leukemia (ALL)
  • Chronic lymphocytic leukemia (CLL)
  • Follicular lymphoma
  • Mantle cell lymphoma
  • B cell prolymphocytic leukemia (PLL)
  • Diffuse large cell lymphoma 
However, all potential study candidates must meet all study specified eligibility criteria in order to be enrolled in the study.

What are requirements to participate in the trial?

The CAR T Cells Trial requires patients have had at least two prior regimens and have some progression after the second regimen. All potential study candidates must provide written consent prior to undergoing any study related tests or procedures. They must also undergo screening tests/procedures to determine eligibility to participate in the study. In order to qualify patients must meet all protocol specified eligibility criteria.

Am I too old/ young to participate in the trial?

Patients must be at least 18 years old in order to participate.

Do I need to live in Philadelphia to participate in the CAR T Cells Trial?

Although it is not a requirement  to live in Philadelphia to participate, frequent multiple study visits are required weekly for the first 2 months and may necessitate patients to take temporary residence near University of Pennsylvania. Additionally, numerous study procedures and follow-up visits must be take place at the Hospital of University of Pennsylvania or Perelman Center for Advanced Medicine

Do I need insurance to participate in the clinical trial?

Investigational procedures for the study such as collection, manufacturing and administration of cells are paid for by the study. Other aspects of care throughout the course of the study that are part of the patient routine care monitoring will be billed to the patient’s insurance.

How can I learn more about the CAR T Cells Trial at Penn?

You may follow this blog for updates on our CART-19 trial. Learn more about the CAR T Cells Trial’s findings or other clinical trials currently enrolling patients at the Abramson Cancer Center or, Oncolink or www.clinicaltrials.gov. Or call 800-474-9892 to find a clinical trial right for you.


Learn more about the hematological malignancies (blood cancers) program at the Abramson Cancer Center.

How can I help make cancer research possible at Penn Medicine?

Philanthropy plays a key role in supporting novel advances in research, which are often deemed too risky to be funded through traditional sources. We are at the forefront of discovering ways to adapt recent immunotherapy breakthroughs to even more types of cancer, providing hope for many in our community and beyond. Philanthropy continues to be the catalyst for moving these discoveries forward quickly.

Learn how you can support the CAR T Cells Trial at Penn Medicine with a gift.

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