NCT00301821|CompletedPhase 2ResultsDMC

Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

NCCTG-N0489NCI-2012-02685CDR0000459932

Study Type

interventional

Target

107

Locations

1 country

Sites

162

Timeline

RegisteredMar 2006

StartedJan 2006

CompletionApr 2015

Brief Summary

RATIONALE: Monoclonal antibodies, such as epratuzumab and 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, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells.\> PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

107

participants targeted

Target at P75+ for phase_2 lymphoma

Timeline

Completed

Started Jan 2006

Longer than P75 for phase_2 lymphoma

Geographic Reach

1 country

162 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.3 years study duration

Study Start

First participant enrolled

January 1, 2006

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2006

Completed

4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2006

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed

6.5 years until next milestone

Results Posted

Study results publicly available

March 24, 2015

Completed

8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed

Last Updated

October 9, 2019

Status Verified

October 1, 2019

Enrollment Period

2.8 years

First QC Date

March 9, 2006

Results QC Date

March 13, 2015

Last Update Submit

October 1, 2019

Conditions

Lymphoma

Keywords

contiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (1)

Event-free Survival After 12 Months
The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12).
From Baseline to 12 months

Secondary Outcomes (3)

Overall Survival
time from study entry to 36 months
Progression-free Survival (PFS)
the time from study entry to 36 months
Overall Response Rate (ORR)
Baseline to first 6 cycles of treatment

Study Arms (1)

Epratuzumab + Rituximab + CHOP

EXPERIMENTAL

One arm open label.

Biological: epratuzumabBiological: rituximabDrug: cyclophosphamideDrug: doxorubicin hydrochlorideDrug: prednisoneDrug: vincristine sulfate