Clinical Trial · NCT00690560

Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma

Overview

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vincristine, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Steroid therapy, such as prednisone, may be effective in treating cancer and blocking the body's immune response. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, 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. Giving chemotherapy together with prednisone and monoclonal antibody therapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving doxorubicin together with vincristine, cyclophosphamide, prednisone, and rituximab followed by rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with newly diagnosed large B-cell lymphoma.

Sponsor

Centre Antoine Lacassagne

Phase

Phase 2

Contacts

Frederec Peyrade, MD (STUDY_CHAIR)

ClinicalTrials.gov

NCT00690560

Drug / Compound

ibritumomab tiuxetan

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

Eligibility

Inclusion

  • At least 30 days since prior and no other concurrent investigational treatment
  • Histologically confirmed large B-cell lymphoma
  • Measurable disease
  • CD20-positive disease
  • Bilirubin ≤ 30 mmol/L
  • Stage I, II, III, or IV disease
  • Creatinine ≤ 150 μmol/L
  • Bone marrow or lymph node involvement by small cell lymphoma allowed
  • ALT and AST ≤ 2.5 times upper limit of normal

Exclusion

  • No serious, progressive pathology (at investigator's discretion)
  • No prior indolent lymphoma, treated or not
  • No prior therapy
  • No meningeal or CNS lymphoma
  • No contraindication to chemotherapy or immunotherapy