Track topics on Twitter Track topics that are important to you
PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with B-cell leukemia or lymphoma that is resistant or refractory to chemotherapy.
I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD19 lentiviral vector (referred to as CART-19 cells).
II. Determine duration of in vivo survival of CART-19 cells. RT-PCR analysis of whole blood will be used to detect and quantify survival of CART-19 TCR zeta:4-1BB and TCR zeta cells over time.
I. For patients with detectable disease, measure anti-tumor response due to CART-19 cell infusions.
II. To determine if the 4-1BB transgene is superior to the TCR zeta only transgene as measured by the relative engraftment levels of CART-19 TCR zeta:4-1BB and TCR zeta cells over time.
III. Estimate relative trafficking of CART-19 cells to tumor in bone marrow and lymph nodes.
IV. For patients with stored or accessible tumor cells (such as patients with active CLL, ALL, etc) determine tumor cell killing by CART-19 cells in vitro.
V. Determine if cellular or humoral host immunity develops against the murine anti-CD19, and assess correlation with loss of detectable CART-19 (loss of engraftment).
VI. Determine the relative subsets of CART-19 T cells (Tcm, Tem, and Treg).
OUTLINE: Patients are assigned to 1 of 2 groups according to order of enrollment.
Group 1 (Patients 1-5): Patients receive anti-CD19-CAR retroviral vector-transduced autologous T cells with 41BB-gamma vector on days 0,1, 2, and 11 in the absence of disease progression or unacceptable toxicity.
Group 2 (Patients 6-10): Patients receive anti-CD19-CAR retroviral vector-transduced autologous T cells with either 41BB-gamma vector or TCR zeta vector on days 0,1, 2, and 11 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 13 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
laboratory biomarker analysis, polymerase chain reaction, reverse transcriptase-polymerase chain reaction, anti-CD19-CAR retroviral vector-transduced autologous T cells, genetically engineered lymphocyte therapy
Abramson Cancer Center of The University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Published on BioPortfolio: 2014-08-27T03:17:24-0400
RATIONALE: Studying samples of tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to c...
RATIONALE: Finding genetic markers for thyroid cancer in a biopsy specimen may help doctors diagnose thyroid cancer. PURPOSE: This clinical trial is studying how well genetic analysis wor...
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. ...
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It ...
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to fatigue. ...
The full potential of the real-time reverse transcription polymerase chain reaction (RT-PCR) as a rapid and accurate diagnostic method is limited by DNA polymerase inhibitors as well as reverse transc...
Human telomerase reverse transcriptase (TERT) is the catalytic subunit of telomerase, and it elongates telomere through RNA-dependent DNA polymerase activity. Although TERT is named as a reverse trans...
We assessed the applicability of giant unilamellar vesicles (GUVs) for RNA detection using in vesicle reverse transcription polymerase chain reaction (RT-PCR). We prepared GUVs that encapsulated one-p...
The analysis of microRNA expression patterns provides new insights into numerous cellular processes and their aberrances in diseases. Despite its potential pitfalls, the quantitative real-time polymer...
A variation of the PCR technique in which cDNA is made from RNA via reverse transcription. The resultant cDNA is then amplified using standard PCR protocols.
DNA sequences that form the coding region for retroviral enzymes including reverse transcriptase, protease, and endonuclease/integrase. "pol" is short for polymerase, the enzyme class of reverse transcriptase.
Inhibitors of reverse transcriptase (RNA-DIRECTED DNA POLYMERASE), an enzyme that synthesizes DNA on an RNA template.
Methods for using more than one primer set in a polymerase chain reaction to amplify more than one segment of the target DNA sequence in a single reaction.
Methods used for detecting the amplified DNA products from the polymerase chain reaction as they accumulate instead of at the end of the reaction.
Bioinformatics is the application of computer software and hardware to the management of biological data to create useful information. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied...
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells. In vertebrates, it is composed of blo...
Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers) - Mouth cancer can develop on the lip, the tongue, the floor...