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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
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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Primary Eligibility:

• Diagnosis of a CD19-expressing B-cell malignancy of any type
• CD19 expression on > 50% of the malignant cells by immunohistochemistry or flow cytometry
• Meets one of the following criteria:
• Progressive disease after ≥ 1 standard chemotherapy regimen (for patients with CLL, mantle cell lymphoma, or follicular lymphoma)
• Progressive disease after ≥ 2 prior chemotherapy regimens, one of which must have contained doxorubicin hydrochloride and rituximab (for patients with large cell lymphoma)
• 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

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Study Outline:

This is a Phase I dose-escalation study of anti-CD19 cells followed by a randomized Phase II study. Patients enrolled in the Phase II portion are randomized to receive anti-CD19 cells either with or without prior chemotherapy.

Phase I:

• Patients receive cyclophosphamide IV over 1 hour on Days -7 and -6 and fludarabine phosphate IV over 30 minutes on Days -5 to -1
• Patients then receive anti-CD19 cells IV over 20–30 minutes on Day 0 and aldesleukin IV over 15 minutes every 8 hours on Days 0–4

Phase II:

• Patients are randomized to one of two treatment arms
• Arm I:
• Patients receive cyclophosphamide IV over 1 hour on Days -7 and -6 and fludarabine phosphate IV over 30 minutes on Days -5 to -1
• Patients then receive anti-CD19 cells IV over 20–30 minutes on Day 0 and aldesleukin IV over 15 minutes every 8 hours on Days 0–4
• Arm II:
• Patients receive anti-CD19 cells and aldesleukin as in Arm I, without the preparative chemotherapy agent


• Patients are evaluated 4–6 weeks after completion of aldesleukin
• Blood samples are collected periodically
• 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, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/29/09
Updated: 6/4/09