TheranosticTrials.org

Clinical Trial · NCT00440583

The Response Study of Yt90-Zevalin in Patients With Diffuse Large B-cell Lymphoma After 6 Cycles of CHOP

Overview

The purpose of this study is to determine the effective of Yt90-Zevalin therapy in patients with diffuse large B-cell lymphoma that have achieved at least an unconfirmed partial remission after 6 cycles of CHOP therapy.

Sponsor

Ankara University

Phase

Phase 2

Contacts

Surapol Issaragrisil, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00440583

Drug / Compound

ibritumomab tiuxetan

Isotope(s):
Target(s):
  • CD20 antigen
Ligand Class: Antibodies
Chelator: tiuxetan

Eligibility

Inclusion

  • Performance status Zubrod 0-2
  • Less than 20,000/mcL circulating lymphoid cells on WBC differential count
  • Bidimensionally measurable disease
  • Renal : Not specified
  • No known HIV positive
  • Adequate sections AND a paraffin block OR ≥ 10 unstained sections from the original diagnostic specimen available
  • No histologic transformation
  • Surgery : No prior solid organ transplantation
  • All adult patients of reproductive potential must use contraception during and for 6 months after completion of study treatment
  • Cardiovascular
  • PRIOR CONCURRENT THERAPY:
  • Ejection fraction ≥ 45% by MUGA OR
  • Biologic therapy : No prior antibody therapy for lymphoma
  • Other
  • Life expectancy : Not specified
  • No significant abnormalities by echocardiogram
  • Chemotherapy : 6 cycles of CHOP
  • Radiotherapy : No prior radiotherapy for lymphoma
  • Needle aspiration or cytology are not considered adequate
  • Pulmonary : No requirement for continuous supplemental oxygen
  • Histologically confirmed, CD 20 positive diffuse large B-cell lymphoma, meeting 1 of the following stage criteria: Bulky stage II disease, Stage III disease, Stage IV disease at the initial diagnosis.
  • Endocrine therapy : Not specified
  • No clinical evidence of CNS involvement by lymphoma
  • No prior diagnosis of indolent lymphoma
  • Hepatic : Not specified

Exclusion

  • Concurrent severe and/or uncontrolled medical disease which could compromise the participation in the study
  • Positive serology of HCV with the presence of HCV RNA of chronic hepatitis
  • Patients in whom more than 25% of the bone marrow has been infiltrated by lymphoma cells
  • Previous antineoplastic treatment other than the 6 cycles of CHOP for the initial treatment of DLBCL
  • Patients with platelet counts \<100,000/µl or neutrophil counts \< 1500/µl
  • Active uncontrolled infection
  • Positive HIV serology
  • Positive serology of HBV with the presence of HBV RNA of chronic hepatitis
  • Serum creatinine or bilirubin \> 2.5 x upper limit of normal