CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 98 enrolled
Drug / intervention
filgrastim +10 morebiological
Likely dose
Typical R-CHOP-like regimen: rituximab + cyclophosphamide + doxorubicin + vincristine + prednisone, with escalation or stem cell transplant based on risk; specific doses not stated in arms/interventionsAI-extracted
Key inclusion· 9
  • Histologically confirmed aggressive diffuse large B-cell lymphoma
  • CD20-positive disease
  • Age-adjusted International Prognostic Index II or III (defined by Karnofsky 10–70%, LDH >200 U/L, or stage III/IV)
  • PET-avid measurable disease
Key exclusion· 10
  • Prior chemotherapy for malignancy
  • Prior biologic therapy for malignancy
  • Prior radiotherapy for malignancy
  • Prior surgery for malignancy

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

Search/NCT00039195
NCT00039195Phase 2Completed

Risk-Adapted Therapy for Patients With Untreated Age-Adjusted International Prognostic Index II or III Diffuse Large B Cell Lymphoma

Memorial Sloan Kettering Cancer Center·interventional·Posted Jan 27, 2003·Updated Aug 10, 2016

In Brief

A Phase 2 clinical trial evaluating filgrastim, rituximab, and 9 other interventions for Lymphoma. Completed, enrolled 98 participants across 1 site.

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 chemotherapy with monoclonal antibody therapy, total-body irradiation, and peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well giving chemotherapy with rituximab followed by combination chemotherapy with or without rituximab, total-body irradiation, and peripheral stem cell transplant works in treating patients with lymphoma.

Study Details

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

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartNov 1, 2006
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 23.4 years ago

Interventions

filgrastimbiological

rituximabbiological

carboplatindrug

cyclophosphamidedrug

doxorubicin hydrochloridedrug

etoposidedrug

ifosfamidedrug

prednisonedrug

vincristine sulfatedrug

peripheral blood stem cell transplantationprocedure

radiation therapyradiation