CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
rituximab +5 morebiological
Likely dose
rituximab 375 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01004991
NCT01004991Phase 2Completed
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Phase I/II Trial of Azacytidine + R-CHOP in Diffuse Large B-Cell Lymphoma

Weill Medical College of Cornell University·interventional·Posted Oct 30, 2009·Updated Apr 10, 2017

In Brief

A Phase 2 clinical trial evaluating rituximab, cyclophosphamide, and 4 other interventions for Diffuse Large B Cell Lymphoma. Completed, enrolled 14 participants across 1 site.

Detailed Summary

This is a phase I/II open label, multi-center study of azacytidine in combination with standard RCHOP therapy in patients with DLBCL. Patients will be treated with azacytidine at escalating doses on days 1-5, followed by standard dose rituximab plus CHOP chemotherapy on day 8, every 21 days. Patients will be treated for a total 6 cycles. The phase II portion will then evaluate efficacy of the combination at the established MTD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Large B Cell Lymphoma
CountriesUnited States
CollaboratorsCelgene

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 30, 2009
Enrollment StartJan 1, 2010
Primary CompletionSep 1, 2013
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 16.7 years ago

Interventions

rituximabbiological

375 mg/m2 on Day 8 of each of 6 cycles

cyclophosphamidedrug

750 mg/m2 on Day 8 of each of 6 cycles

vincristinedrug

1.4 mg/m2 on Day 8 of each of 6 cycles

doxorubicindrug

50 mg/m2 on Day 8 of each of 6 cycles

prednisonedrug

100 mg PO days 8-12 of each of 6 cycles

azacytidinedrug

Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5