CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
filgrastim +8 morebiological
Likely dose
Rituximab 375 mg/m² on day 1 of cycles 1-6; cyclophosphamide 300 mg/m² days 2-4; doxorubicin 16.6 mg/m²/day days 5-7; vincristine 1.4 mg/m² days 5 and 12; dexamethasone 40 mg days 2-5 and 12-15 of odd cycles; methotrexate 1000 mg/m² days 2-3; cytarabine 12 g/m² days 3-4; leucovorin 170 mg days 3-5 of even cyclesAI-extracted
Key inclusion· 8
  • ✓Histologically proven stage III/IV mantle cell lymphoma or bulky stage II disease
  • ✓Newly diagnosed and previously untreated disease
  • ✓Bidimensionally measurable disease
  • ✓Age 18 to 69 years
Key exclusion· 7
  • ✕Prior monoclonal antibody therapy
  • ✕Prior chemotherapy for lymphoma
  • ✕Prior radiotherapy for lymphoma
  • ✕Known AIDS syndrome or HIV-associated complex

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

Search/NCT00041132
NCT00041132Phase 2Completed
CompareCT.gov

Pilot Trial of Hyper-CVAD and Methotrexate/ARA C Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

SWOG Cancer Research Network·interventional·Posted Jan 27, 2003·Updated Nov 1, 2012

In Brief

A Phase 2 clinical trial evaluating filgrastim, rituximab, and 7 other interventions for Lymphoma. Completed, enrolled 56 participants.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining rituximab with chemotherapy may kill more cancer cells. PURPOSE: Phase II pilot study to study the effectiveness of combining chemotherapy with rituximab in treating patients who have newly diagnosed mantle cell lymphoma.

Study Details

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

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartSep 1, 2002
Primary CompletionNov 1, 2007
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 23.4 years ago

Interventions

filgrastimbiological

5 ug/kg

rituximabbiological

375 mg/m\^2 on day 1 of cycles 1-6

cyclophosphamidedrug

300 mg/m\^2 on days 2-4 of cycles 1,3,5,7

cytarabinedrug

12 g/m\^2 over days 3-4 of cycles 2,4,6,8

dexamethasonedrug

40 mg on days 2-5 and 12-15 of cycles 1,3,5,7

doxorubicindrug

16.6 mg/m\^2/day for days 5-7 of cycles 1,3,5,7

leucovorindrug

170 mg over days 3-5 of cycles 2,4,6,8

methotrexatedrug

1000 mg/m\^2 over days 2-3 of cycles 2,4,6,8

vincristinedrug

1.4 mg/m\^2 on days 5 and 12 of cycles 1,3,5,7