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Investigator(s):
Steven A. Rosenberg, M.D., Ph.D. Principal Investigator Phone: 1-866-820-4505 (Toll Free) ncisbirc@mail.nih.gov	James N. Kochenderfer, M.D. Assistant Clinical Investigator Phone: 301-594-5340 Fax: 301-451-5578 kochendj@mail.nih.gov
Referral Contact(s):
June A. Kryk, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov	Linda Williams, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov

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Key Eligibility Criteria:

• Diagnosis of a CD19-expressing B-cell malignancy of any type
• Patients with CLL, mantle cell lymphoma, and follicular lymphoma must have progressive disease after at least one standard chemotherapy regimen
• Patients with large cell lymphoma must have progressive disease after at least two prior chemotherapy regimens, one of which must have contained doxorubicin and rituximab
• Patients with ALL must have relapsed or refractory disease after at least one standard chemotherapy and one salvage regimen
• All patients enrolled on this trial must be deemed incurable by standard therapies
• CD19 expression on > 50% of the malignant cells by immunohistochemistry or flow cytometry
• No CNS metastases
• Recovered from prior therapy
• No prior allogeneic stem cell transplantation
• No concurrent systemic steroid therapy
• Not pregnant or nursing; fertile patients must use effective contraception during and for 4 months following completion of study treatment
• HIV, hepatitis B, and hepatitis C negative
• No medical condition that would preclude study participation, such as active systemic infections; coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system; myocardial infarction; cardiac arrhythmias; obstructive or restrictive pulmonary disease
• No history of severe immediate hypersensitivity reaction to any of the agents used in this study
• Platelet count of 75,000/microliter or higher

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Study Outline:

• Leukapheresis to obtain white blood cells that are then modified and grown in the laboratory
• Non-myeloablative lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine
• After completion of the preparative regimen, patients will receive an IV infusion of their modified blood cells (anti-CD19 cells)
• Follow-up evaluation 4–6 weeks after completion of treatment
• After completion of study treatment, patients are followed periodically for up to 15 years

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 12/14/12
Updated: 9/5/12