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Investigator(s):
Michael Bishop, M.D. Principal Investigator Phone: 301-435-2764 mbishop@mail.nih.gov	Nancy Hardy, M.D. Protocol Chair Phone: 301-451-1406 hardyn@mail.nih.gov
Referral Contact(s):
Bazetta (Zetta) Blacklock, R.N., B.S., B.S.N. Transplant Coordinator Phone: 301-594-2056 Fax: 301-435-6830 bblacklock@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed B-cell non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia or multiple myeloma
• Persistent or recurrent disease after alloHSCT and the following post-transplant therapeutic maneuvers:
• A trial of withdrawal of immunosuppressive therapy
• Administration of ≥ 1 DLI with a minimum T-cell dose of 1 x 10⁷ CD3-positive cells/kg*
• Evidence of established full-donor T-cell engraftment (> 90% chimerism of the circulating T-cell compartment)
• Presence of at least one tumor ≥ 1.5 cm³ that is surgically accessible with minimal surgical morbidity
• Presence of at least one other site of disease that permits monitoring for response to therapy
• Minimal to no clinical evidence (grade 0–1) of acute GVHD or limited-stage chronic GVHD while off systemic steroid therapy for ≥ 4 weeks
• No active leptomeningeal involvement with malignancy
• Lumbar puncture required for patients with aggressive NHL, history of leptomeningeal disease, or signs or symptoms suggestive of leptomeningeal involvement
• ECOG 0–2
• Absolute neutrophil count ≥ 500/mm³ (without transfusion)
• Platelet count ≥ 20,000/mm³ (without transfusion) (> 50,000/mm³, if transfusion-dependent)
• Creatinine < 2.5 mg/dL
• AST and ALT < 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if attributable to liver involvement by malignancy**)
• PT and PTT normal (or demonstrably not related to coagulopathy) LVEF ≥ 45% by MUGA or 2-dimensional echocardiogram
• DLCO ≥ 50% of predicted (corrected for hemoglobin)
• No active infection that is not responding to antimicrobial therapy
• HIV, hepatitis B surface antigen, and hepatitis C antibody negative
• No active psychiatric illness that would preclude compliance with transplantation protocol or giving informed consent
• Not pregnant or nursing; fertile patients must use effective contraception during and for 1 year after completion of study therapy

*Patients whose donors are unavailable, including those who received alternative donor alloHSCT (e.g., haploidentical, matched unrelated, umbilical cord blood) do not require DLI to be eligible.
**Provided the patient has no evidence of impending hepatic failure (i.e., encephalopathy or PT > 2 times ULN).

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Treatment Plan:

This is a pilot study.

• Patients undergo apheresis to collect plasma for cell culture and peripheral blood mononuclear cells (PBMCs) for research evaluation
• Patients then undergo surgical resection of accessible tumor; tumor-infiltrating lymphocytes (TILs) are isolated from tumor tissue, costimulated, and expanded ex vivo to generate TDL
• Beginning at least 24 days after surgery and within 7 days after tumor assessment, patients receive an infusion of TDL
• Patients undergo blood, bone marrow, and tissue collection periodically during study
• After completion of study therapy, patients are followed periodically for up to 5 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: 7/7/08
Updated: 1/14/09