Phase IIa Study for Refractory Central Nervous System Lymphoma

A Phase IIA Study of the Addition of Temozolomide to a Standard Conditioning Regimen for Autologous Stem Cell Transplantation in Relapsed and Refractory Central Nervous Systems (# 19873)

  • A mature B-cell lymphoma originating in the central nervous system (CNS)
  • Patients with relapsed disease following therapy for CNS B cell lymphoma
  • Patients with refractory disease in spite of therapy for CNS lymphoma
  • Patients who have developed CNS B cell CNS lymphoma in the setting of systemic disease as well. Provided there is limited systemic disease, such patients would be eligible

We are evaluating the DRBEAT regimen. The D represents decadron, a steroid which is used as a standard pre-medication in the RBEAM regimen. The D is simply added to the name. The main difference between the RBEAM regimen and the DRBEAT regimen will be the replacement of melphalan with temozolomide which has superior penetration into the CSF. Temozolomide will be given as a daily dose over five days starting on D -5 of the Autologous PBSCT.  An adaptive dose escalation design will be used to determine the target dose for this study but we expect to use doses up to 10X currently used to treat relapsed disease which have been limited by hematotoxicity.

Surasak Phuphanich, MD, FAAN
Director, Neuro-oncology Program
Phone: 310-423-8100
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