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Investigator(s):
John E. Janik, M.D. Principal Investigator Phone: 301-402-2913 janikj@mail.nih.gov
Referral Contact(s):
Therese White, R.N., M.S.N. Research Nurse Phone: 301-402-5886 whiteth@mail.nih.gov

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Primary Eligibility:

• Diagnosis of T-cell or natural killer (NK)-cell lymphoma confirmed by pathology or flow cytometry; includes, but is not limited to, any of the following:
• Peripheral T-cell lymphoma (not otherwise specified)
• Gamma-delta hepatosplenic T-cell lymphoma
• Subcutaneous panniculitis-like T-cell lymphoma
• NK T-cell lymphoma
• CD2-expressing disease confirmed by pathology or flow cytometry
• At least 30% of the malignant cells must be CD2 positive
• Chemotherapy-naïve disease
• No ALK-positive anaplastic large-cell lymphoma or precursor T-cell lymphoma
• ≥ 18 years of age
• ANC ≥ 1,000/mm³*
• Platelet count ≥ 75,000/mm³*
• Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min*
• Bilirubin < 2 mg/dL* unless due to Gilbert’s syndrome (unconjugated hyperbilirubinemia without another known cause)
• AST and ALT ≤ 3 x upper limit of normal (ULN)* (≤ 6 x ULN for patients on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation)
• Not pregnant or nursing; fertile patients must use effective contraception
• HIV negative
• No active symptomatic ischemic heart disease, myocardial infarction, or congestive heart failure within the past year
• No medical condition that would preclude study participation

*Unless impairment is due to respective organ involvement by the tumor.

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Study Outline:

This is a dose-escalation study of siplizumab.

• Patients receive siplizumab IV on Day 1
• Patients also receive etoposide IV, vincristine IV, and doxorubicin IV on Days 1–4; rituximab IV and cyclophosphamide IV on Day 5; and oral prednisone twice daily on Days 0–5
• Patients also receive filgrastim subcutaneously daily beginning on Day 6 and continuing until blood counts recover
• Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
• After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter

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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: 
Updated: 5/20/09