CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD)drug
Likely dose
Rituximab 375 mg/m² IV weekly ×4 (1 cycle); dexamethasone 40 mg PO/IV days 2-5 every 21 days ×2 cycles; oxaliplatin 130 mg/m² IV day 2 every 21 days ×2 cycles; cytosine arabinoside 2000 mg/m² ×2 doses IV days 2-3 every 21 days ×2 cyclesAI-extracted
Key inclusion· 7
  • Relapsed CD20+ B-cell NHL (diffuse large cell, mantle cell, or transformed histologies) within 5 years, aggressive histology, not responding to or relapsed after initial chemotherapy
  • Candidate for platinum-containing regimen if treated off-study
  • Measurable disease ≥1.5 × 1.5 cm
  • Tumor biopsy ≤6 weeks prior confirming CD20+ histology
Key exclusion· 7
  • HIV infection
  • Prior chemotherapy or biologic therapy ≤4 weeks prior to registration
  • Persistent acute toxicities from prior chemotherapy or biologic therapy
  • Active malignancies other than NHL

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

Search/NCT00166439
NCT00166439Phase 2Completed

A Phase II Trial of Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) in Patients With Relapsed CD20+ B-Cell Non-Hodgkins Lymphoma

Academic and Community Cancer Research United·interventional·Posted Sep 14, 2005·Updated Jan 14, 2020

In Brief

A Phase 2 clinical trial evaluating Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) for Lymphoma. Completed, enrolled 50 participants across 1 site.

Detailed Summary

The goals of this protocol are to determine the effect of oxaliplatin, cytosine arabinoside, and dexamethasone with Rituxan (ROAD) as treatment for patients with relapsed CD20+ B-cell non-Hodgkins lymphoma (NHL).

Study Details

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

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2005
Enrollment StartMar 1, 2005
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10.5 yearsPosted 20.8 years ago

Interventions

Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD)drug

rituximab 375 mg/m2 IV Weekly x 4 1 cycle only dexamethasone 40 mg PO/IV Days 2-5 q 21 days 2 cycles oxaliplatin 130 mg/m2 IV Day 2 q 21 days 2 cycles cytosine arabinoside 2000 mg/m2 x 2 doses IV Days 2-3 q 21 days 2 cycles pegfilgrastim 6 mg SQ Day 4 q21 days 2 cycles