CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
rituximab +3 morebiological
Likely dose
Rituximab (dose not specified in interventions) and yttrium Y 90 ibritumomab tiuxetan (dose not specified)AI-extracted
Key inclusion· 7
  • Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma (including B-cell diffuse large cell, immunoblastic, mediastinal, T-cell/histiocyte-rich, anaplastic large B-cell, intravascular, or lymphomatoid granulomatosis variants)
  • Relapsed or refractory disease after at least 1 prior chemotherapy regimen with new lesions, ≥50% increase in size of previously involved sites, or progressive disease during/at end of therapy
  • CD20-positive disease confirmed by immunohistochemistry
  • Bidimensionally measurable disease with at least 1 lesion ≥2.0 cm on CT scan
Key exclusion· 7
  • Transformed lymphoma from indolent to aggressive histology
  • HIV- or AIDS-related lymphoma
  • Hypocellular bone marrow or marked reduction in bone marrow precursors (granulocytic, megakaryocytic, or erythroid cell lines)
  • CNS lymphoma

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

Search/NCT00073957
NCT00073957Phase 2Completed

Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Beth Israel Deaconess Medical Center·interventional·Posted Dec 11, 2003·Updated Jan 23, 2018

In Brief

A Phase 2 clinical trial evaluating rituximab, cytarabine, and 2 other interventions for Lymphoma. Completed, enrolled 25 participants across 2 sites.

Detailed Summary

RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 11, 2003
Enrollment StartDec 1, 2003
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 22.6 years ago

Interventions

rituximabbiological

cytarabinedrug

to be used for CNS prophylaxis

liposomal cytarabinedrug

to be used as CNS prophylaxis

yttrium Y 90 ibritumomab tiuxetanradiation