Siplizumab Combination Chemotherapy and Rituximab in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin Lymphoma

  • participants needed
  • sponsor
    National Cancer Institute (NCI)
Updated on 7 November 2020
monoclonal antibodies
combination chemotherapy


RATIONALE: Monoclonal antibodies, such as siplizumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine , cyclophosphamide, and doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from growing. Giving siplizumab together with combination chemotherapy and rituximab may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of siplizumab when given together with combination chemotherapy and rituximab in treating patients with T-cell or natural killer-cell non-Hodgkin lymphoma.


OBJECTIVES: Primary - Determine the toxicity of siplizumab in combination with dose-adjusted etoposide, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride, and rituximab (DA-EPOCH-R) in patients with chemotherapy-naive, CD2-expressing T-cell or natural killer (NK)-cell non-Hodgkin lymphoma. - Determine the maximum tolerated dose of siplizumab in combination with DA-EPOCH-R in these patients. Secondary - Determine, preliminarily, the anti-tumor activity of siplizumab and DA-EPOCH-R in these patients. - Determine the time course of B-, T-, and NK-cell depletion. - Determine the time course of B-, T- and NK-cell recovery. - Monitor EBV reactivation and its association with the development of EBV lymphoproliferative disease. OUTLINE: This is a dose-escalation study of siplizumab. Patients receive siplizumab IV on day 1. Patients also receive dose-adjusted rituximab IV on day 1; etoposide IV, vincristine sulfate IV, and doxorubicin IV over 96 hours on days 1-4; cyclophosphamide IV over 30 minutes on day 5; and oral prednisone twice daily on days 1-5. Patients also receive filgrastim (G-CSF) 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. Patients undergo blood sample collection at baseline, during study, and after completion of study for pharmacokinetic studies via liquid chromatography mass spectrometry/mass spectrometry and ELIZA assay and for the evaluation of immunogenicity via human anti-humanized antibody assay. 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.

Condition Lymphoma
Treatment Rituximab, cyclophosphamide, doxorubicin hydrochloride, etoposide, prednisone, vincristine sulfate, immunoenzyme technique, pharmacological study, mass spectrometry, liquid chromatography, siplizumab
Clinical Study IdentifierNCT00832936
SponsorNational Cancer Institute (NCI)
Last Modified on7 November 2020


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