View Clinical Trial (Medical Research Study)
Phase I Study of CD19 Chimeric Receptor Expressing T Lymphocytes in B-Cell Non Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia [CRETI-NH]
| City: |
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Houston |
| State: |
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Texas |
| Zip Code: |
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77030 |
| Conditions: |
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Leukemia - Lymphoma |
| Purpose: |
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RATIONALE: Gene-modified T lymphocytes may help the body build an effective immune response
to kill cancer cells.
PURPOSE: This phase I trial is studying the side effects and best way to give T lymphocytes
in treating patients with relapsed or refractory low-grade B-cell non-Hodgkin lymphoma or
chronic lymphocytic leukemia.
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| Study Summary: |
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OBJECTIVES:
Primary
- To evaluate the safety of autologous T-lymphocytes genetically modified to express
artificial T-cell receptors (CAR) targeting the CD19 molecule (CD19CAR) in patients
with refractory or relapsed low-grade B-cell non-Hodgkin lymphoma or chronic
lymphocytic leukemia.
Secondary
- To measure the survival and function of CD19CAR T-cells in vivo.
- To compare two different T-cell products in the same patient in which the CD19CAR will
differ only by the inclusion of the CD28 co-stimulatory endodomain.
- To measure the antitumor effects of chimeric CD19 receptor transduced autologous
T-lymphocytes in these patients.
OUTLINE: Patients receive 2 infusions of CD19 chimeric receptor-expressing T-lymphocytes
(CD19CAR) or CD19CAR-28 IV over 1-10 minutes on day 0.
Patients undergo blood sample collection periodically for laboratory studies. Samples are
analyzed for retroviral integrants via quantitative real-time PCR; interferon-γ release
using CD19 positive cells and CD19 negative target cells via ELISPOT; retroviral integrant
clonality and integrant locus if transgenes detected at > 0.5% via PCR; and for the
measurement of human anti-mouse antibodies (HAMA). Some samples are archived and used for
future studies.
After completion of study treatment, patients are followed at 1, 2, 4, and 6 weeks, every 3
months for 1 year, every 6 months for 4 years, and then annually for up to15 years.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Diagnosis of recurrent low-grade* B-cell lymphoma or chronic lymphocytic leukemia
- Newly diagnosed patients unable to receive or complete standard therapy are
eligible
- Available autologous transduced peripheral blood T-cells with ≥ 15% expression of
CD19 artificial T-cell receptors determined by flow cytometry
- No tumor in a location where enlargement could cause airway obstruction NOTE: *A new
classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The
terminology of "indolent" or "aggressive" lymphoma will replace the former
terminology of "low", "intermediate", or "high" grade lymphoma. However, this
protocol uses the former terminology.
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Life expectancy ≥ 12 weeks
- ANC > 500/mm³
- Hemoglobin > 8.0 g/dL
- Bilirubin < 3 times upper limit of normal (ULN)
- AST < 5 times ULN
- Serum creatinine < 3 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
therapy
- Pulse oximetry > 90% on room air
- No history of hypersensitivity reactions to murine protein-containing products
PRIOR CONCURRENT THERAPY:
- Recovered from toxic effects of all prior chemotherapy before entering this study
- More than 6 weeks since prior tumor vaccines
- No other concurrent investigational agents
- May not receive other anti-neoplastic agents for 6 weeks after infusion of transduced
T-cells
- Patients may receive other therapy if needed at the discretion of the attending
physician
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| NCT ID: |
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NCT00608270 |
| Primary Contact: |
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Principal Investigator
Malcolm K. Brenner, MD, PhD
Baylor College of Medicine
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| Backup Contact: |
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N/A |
| Location Contact: |
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Houston, Texas 77030
United States
Malcolm K. Brenner, MD, PhD
Phone: 832-824-4671
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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