CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
darbepoetin alfa +8 morebiological
Likely dose
R-CHOP (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone) plus indium In 111 ibritumomab tiuxetan followed by yttrium Y 90 ibritumomab tiuxetanAI-extracted
Key inclusion· 10
  • Histologically confirmed diffuse large B-cell lymphoma of specified subtypes (centroblastic, immunoblastic, T-cell/histiocyte-rich, lymphomatoid granulomatosis type, anaplastic large B-cell, plasmablastic, mediastinal, or intravascular)
  • Previously untreated disease
  • High-intermediate or high-risk disease defined by age-adjusted international prognostic index score of 2 or 3
  • CD20+ disease on initial diagnostic specimen
Key exclusion· 14
  • Known brain or leptomeningeal metastases
  • Primary effusion lymphomas
  • Stage I or limited stage II disease confined to an involved-field radiotherapy port
  • Acute myocardial infarction within past 3 months

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

Search/NCT00058422
NCT00058422Phase 2Completed

A Phase II Study of R-CHOP and Ibritumomab Tiuxetan (Zevalin) for Elderly Patients With Previously Untreated Diffuse Large B-Cell Lymphoma

Memorial Sloan Kettering Cancer Center·interventional·Posted Apr 9, 2003·Updated Nov 12, 2020

In Brief

A Phase 2 clinical trial evaluating darbepoetin alfa, filgrastim, and 7 other interventions for Lymphoma. Completed, enrolled 65 participants across 2 sites.

Detailed Summary

RATIONALE: Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab and combination chemotherapy with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab and combination chemotherapy with yttrium Y 90 ibritumomab tiuxetan in treating older patients who have B-cell lymphoma that has not been previously treated.

Study Details

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

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2003
Enrollment StartFeb 10, 2003
Primary CompletionNov 14, 2019
TodayJul 2, 2026
Enrollment to primary: 16.8 yearsPosted 23.2 years ago

Interventions

darbepoetin alfabiological

filgrastimbiological

rituximabbiological

cyclophosphamidedrug

doxorubicin hydrochloridedrug

prednisonedrug

vincristine sulfatedrug

indium In 111 ibritumomab tiuxetanradiation

yttrium Y 90 ibritumomab tiuxetanradiation