CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
Filgrastim +6 morebiological
Likely dose
Rituximab 375 mg/m² IV on day 1, cyclophosphamide 750 mg/m² IV on day 1, pegylated liposomal doxorubicin 40 mg/m² IV (max 90 mg) on day 1, vincristine 2 mg IV on day 1, prednisone 40 mg/m² oral days 1-5, with filgrastim 5 mcg/kg SC daily or pegfilgrastim 6 mg SC once starting 24 hours after chemotherapyAI-extracted
Key inclusion· 6
  • ✓Age 61 years or older
  • ✓Histologically confirmed diffuse large B-cell lymphoma
  • ✓Stage II, III, or IV disease
  • ✓Previously untreated disease
Key exclusion· 8
  • ✕Primary CNS lymphoma or follicular B-cell lymphoma
  • ✕LVEF <50% by echocardiogram or MUGA scan
  • ✕Myocardial infarction within past 6 months
  • ✕NYHA class II-IV heart failure

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

Search/NCT00101010
NCT00101010Phase 2Completed
CompareCT.gov

A Phase II Study Of Rituximab-CHOP With Pegylated Liposomal Doxorubicin In Patients Older Than 60 Years Of Age With Untreated Aggressive B-Cell Non-Hodgkin's Lymphoma

M.D. Anderson Cancer Center·interventional·Posted Jan 10, 2005·Updated Oct 19, 2020

In Brief

A Phase 2 clinical trial evaluating Filgrastim, Pegfilgrastim, and 5 other interventions for Lymphoma. Completed, enrolled 80 participants across 7 sites.

Detailed Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with diffuse large B-cell lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Ortho Biotech, Inc.

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 10, 2005
Enrollment StartSep 1, 2005
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 yearsPosted 21.5 years ago

Interventions

Filgrastimbiological

5 mcg/kg, SC daily, start 24 hours after chemotherapy

Pegfilgrastimbiological

6 mg SC one time (24 hours after chemotherapy)

Rituximabbiological

375 mg/m\^2 intravenous piggy back (IVPB) on day 1, administered 1st

Cyclophosphamidedrug

750 mg/m\^2 IVPB on day 1

Pegylated liposomal doxorubicin hydrochloridedrug

40 mg/m\^2 IV (maximum dose 90 mg) infusion over 1 hour on day 1

Prednisonedrug

40 mg/m\^2 oral days 1 - 5.

Vincristine Sulfatedrug

2 mg IV, day 1