CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
rituximab +7 morebiological
Likely dose
90Y-ibritumomab tiuxetan IV with fludarabine IV and low-dose total body irradiationAI-extracted
Key inclusion· 6
  • Histologically confirmed CD20+ B-cell lymphoma with failure of at least one prior standard systemic therapy
  • Evidence of persistent lymphoma by physical exam, imaging, bone marrow, flow cytometry, or PCR
  • Creatinine <2.0 mg/dL
  • Bilirubin <1.5 mg/dL
Key exclusion· 8
  • Systemic anti-lymphoma therapy within previous 30 days
  • Progressive disease within 3 months of prior Bexxar or Zevalin
  • Central nervous system lymphoma
  • ECOG performance score >2

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00119392
NCT00119392Phase 2Completed

A Phase II Trial Evaluating the Safety and Efficacy of Non-myeloablative 90Y-Ibritumomab Tiuxetan (Anti-CD20) Antibody With Fludarabine, Low-Dose Total Body Irradiation (TBI) and HLA Matched Allogeneic Transplantation for Relapsed B-cell Lymphoma

Fred Hutchinson Cancer Center·interventional·Posted Jul 13, 2005·Updated Jun 29, 2018

In Brief

A Phase 2 clinical trial evaluating rituximab, cyclosporine, and 6 other interventions for B-cell Chronic Lymphocytic Leukemia and 16 related conditions. Completed, enrolled 42 participants across 1 site.

Detailed Summary

Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can block find cancer cells and either kill them or carry cancer-killing substances to them without harming normal cells. Giving monoclonal antibodies, low doses of chemotherapy, such as fludarabine phosphate, and low dose total-body radiation therapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells and also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine or mycophenolate mofetil after the transplant may stop this from happening

Study Details

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 13, 2005
Enrollment StartJun 1, 2004
Primary CompletionJul 1, 2009
Study CompletionApr 23, 2016
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 21.0 years ago

Interventions

rituximabbiological

Given IV

cyclosporinedrug

Given orally

fludarabine phosphatedrug

Given IV

mycophenolate mofetildrug

Given orally

yttrium Y 90 ibritumomab tiuxetanradiation

Given IV

peripheral blood stem cell transplantationprocedure

Undergo transplantation

allogeneic hematopoietic stem cell transplantationprocedure

Undergo transplantation

total-body irradiationradiation

Undergo TBI