CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
rituximab +7 morebiological
Likely dose
CHOP chemotherapy (cyclophosphamide 750 mg/m², doxorubicin 50 mg/m², vincristine 1.4 mg/m², prednisone 100 mg) plus rituximab 250 mg/m² as part of Zevalin regimen, followed by involved-field radiotherapy 4000-5000 cGy total, then Yttrium-90 ibritumomab tiuxetan 0.4 mCi/kgAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed aggressive non-Hodgkin lymphoma: diffuse large B-cell, mantle cell, high-grade B-cell, Burkitt's/Burkitt-like, or anaplastic large cell (B-cell phenotype only)
  • ✓Stage I, IE, or non-bulky stage II or IIE disease (non-bulky defined as <10 cm or <1/3 chest diameter)
  • ✓CD20-expressing disease by flow cytometry or immunoperoxidase staining
  • ✓At least one adverse prognostic factor: non-bulky stage II/IIE, age ≥60 years, Zubrod performance status 2, or LDH >ULN
Key exclusion· 8
  • ✕Bulky stage II or IIE disease (≥10 cm or ≥1/3 chest diameter), even if resected to <10 cm
  • ✕Prior chemotherapy for lymphoma
  • ✕Prior monoclonal antibody therapy
  • ✕Prior radiotherapy for lymphoma

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

Search/NCT00070018
NCT00070018Phase 2Completed
CompareCT.gov

Evaluation of CHOP Plus Involved Field Radiotherapy Followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized, Aggressive Histologies of Non-Hodgkin Lymphoma, Phase II

SWOG Cancer Research Network·interventional·Posted Oct 7, 2003·Updated Jan 11, 2022

In Brief

A Phase 2 clinical trial evaluating rituximab, Cyclophosphamide, and 6 other interventions for Lymphoma. Completed, enrolled 46 participants across 48 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. 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. Combining chemotherapy with radiation therapy and monoclonal antibody therapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy and monoclonal antibody therapy works in treating patients with stage I or stage II non-Hodgkin's lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 7, 2003
Enrollment StartFeb 1, 2004
Primary CompletionNov 1, 2010
Study CompletionJan 8, 2015
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 22.7 years ago

Interventions

rituximabbiological

250 mg/m\^2, as part of Zevalin regimen

Cyclophosphamidedrug

750 mg/m\^2

doxorubicin hydrochloridedrug

50 mg/m\^2

prednisonedrug

100 mg

vincristine sulfatedrug

1.4 mg/m\^2

radiation therapyradiation

4000-5000 cGy total

Yttrium-90 ibritumomab tiuxetanbiological

0.4 mCi/kg

Indium-111 ibritumomab tiuxetanbiological

5 mCi