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Investigator(s):
James N. Kochenderfer, M.D. Principal Investigator Phone: 301-594-5340 Fax: 301-451-5578 kochendj@mail.nih.gov
Referral Contact(s):
Zetta Blacklock, R.N., B.S., B.S.N. Transplant Coordinator Phone: 301-594-2056 Fax: 301-451-5578 bblacklock@mail.nih.gov	Sheila Phang, R.N., M.S. Transplant Coordinator Phone: 301-435-9379 Fax: 301-451-5578 sphang@mail.nih.gov

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Key Eligibility Criteria:

• Aged 18–75 years
• Diagnosis of a CD19+ B-cell malignancy
• Received an HLA-identical sibling allogeneic hematopoietic stem cell transplant (alloHSCT), a 1-antigen mismatched related alloHSCT, or a ≥ 7/8-matched unrelated donor (URD) alloHSCT
• Persistent or relapsed disease after all of the following interventions:
• Full-donor T-cell engraftment (> 90% donor chimerism of the T-cell compartment and a circulating T-cell population) after alloHSCT
• A trial of withdrawal of immunosuppressive therapy
• At least one donor lymphocyte infusion (DLI) with a minimum T-cell dose of 1 x 107 CD3+ cells/kg in the case of HLA-identical sibling transplants and 1-antigen mismatched related transplants or 1x106 CD3+ cells/kg in the case of ≥ 7/8-matched HLA-matched URD transplants*
• Previous allogeneic donor must be willing and available to donate again
• ECOG ≤ 2 (Karnofsky performance status > 60%)
• Minimal clinical evidence of acute GVHD and chronic GVHD while off of systemic immunosuppressive therapy for at least 28 days
• No evidence of infection with HIV, hepatitis B, or hepatitis C
• Absolute neutrophil count ≥ 500 cells/μL and platelet count ≥ 10,000/μL
• No anemia (Hb < 9 g/dL) that cannot be corrected with transfusion
• Serum total bilirubin ≤ 2.5 mg/dL, serum ALT and AST values < 2.5 x upper limit of normal (ULN)
• If liver involvement by malignancy serum total bilirubin up to 5 mg/dL, and serum ALT and AST values up to 5 x ULN, are allowed provided the patient has no evidence of impending hepatic failure
• Not pregnant or breastfeeding

* Prior DLI is not an eligibility requirement for patients with acute lymphoblastic leukemia (ALL)

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Study Outline:

• The alloHSCT recipient will receive the donor’s** engineered anti-CD19 T cells as an intravenous (IV) infusion
• Recipients will be monitored for 72 hours after cell infusion as inpatients
• Visits to the clinic 1, 2, 3, 4, 8, and 12 weeks after the infusion, followed by visits every 3 months, and then every 6 months, and then yearly for a minimum of 5 years

**The alloHSCT donor will undergo leukapheresis, and the peripheral blood mononuclear cells (PBMC) from the alloHSCT donor will be cultured with the anti-CD3 monoclonal antibody OKT3 and interleukin-2 (aldesleukin) and then be genetically modified using replication-incompetent gammaretroviruses encoding an anti-CD19 CAR. These anti-CD19 T cells target the CD19 found on the recipient’s B cells.

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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: 8/29/12
Updated: 12/2/11