Clinical Trial · NCT00336843

Zevalin Plus BuCyE High-dose Therapy in B-cell Non-Hodgkin's Lymphoma

Overview

In order to improve the clinical result of high-dose chemotherapy and autologous stem cell transplantation for B-cell non-Hodgkin's lymphoma, Zevalin will be added to the conditioning regimen. Investigators expect this radioimmunotherapy of Zevalin plus busulfan, cyclophosphamide and etoposide regimen will improve survival of relapsed or poor-risk B-cell non-Hodgkin's lymphoma.

Sponsor

Asan Medical Center

Phase

Phase 2

Contacts

Cheolwon Suh, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00336843

Drug / Compound

ibritumomab tiuxetan

Isotope(s):
Target(s):
  • cd20
Ligand Class: Antibodies
Chelator: tiuxetan

Eligibility

Inclusion

  • Histologically confirmed B-cell NHL in chemotherapy-sensitive relapse, in partial response to 1st line chemotherapy, or in complete response after 1st line chemotherapy with high IPI score at diagnosis
  • Optimal harvest of autologous stem cells (CD34+ cells \> 5 million/kg plus 2 million/kg for back-up)
  • Bilirubin \< 2 mg/dL
  • Transaminase \< 3X upper normal value
  • Life expectancy of at least 3 months
  • ANC \> 1,500/mm3, platelet \> 100,000/mm3
  • WHO performance status (PS) of 0-2
  • Cr \< 2.0 mg% or Ccr \> 50 mL/min

Exclusion

  • Prior biologic or immunotherapy less than 4 weeks prior to entry on this study
  • Pregnant or breast feeding female patients, adults without effective contraception up to 12 months after RIT
  • Investigational drugs less than 4 weeks prior to entry on this study
  • Known hypersensitivity to murine antibodies/proteins
  • CNS involvement of non-Hodgkin's lymphoma
  • Prior external radiation to \> 25% of active bone marrow
  • HIV or HTLV-1 associated malignancy
  • Persistent toxic side effects from prior therapy
  • Prior RIT
  • Serious comorbid diseases
  • Prior hematopoietic stem cell transplantation