NCT00118209|CompletedPhase 3ResultsDMC

Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Phase III Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R With Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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5 other identifiers

CALGB-50303CDR0000433265NCI-2009-00480U10CA031946U10CA180821

Study Type

interventional

Target

524

Locations

1 country

Sites

Timeline

RegisteredJul 2005

StartedMay 2005

CompletionNov 2021

Brief Summary

This randomized phase III trial studies rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell non-Hodgkin's lymphoma. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating diffuse large B-cell non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell lymphoma.

Trial Health

On Track

Trial Health Score

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

Enrollment

524

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started May 2005

Longer than P75 for phase_3

Geographic Reach

1 country

47 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

16.6 years study duration

Study Start

First participant enrolled

May 1, 2005

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 11, 2005

Completed

12.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed

2.5 years until next milestone

Results Posted

Study results publicly available

April 17, 2020

Completed

1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed

Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

12.4 years

First QC Date

July 8, 2005

Results QC Date

April 6, 2020

Last Update Submit

November 15, 2021

Conditions

Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

Progression-Free Survival Rate at 2 and 5 Years
Progression-free survival (PFS) is defined as the time from randomization to progression, relapse, or death from any cause, whichever occurred first. Progression (PD) or Relapse\> * ≥ 50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders.\> * Appearance of any new lesion during or after completion of therapy.\> * PET+ is not a criterion for progressive disease. Patients only with PET+ findings must have evidence of progression on CT or biopsy proven.\> The PFS rate (percentage of participants who are alive and progression-free) at 2 and 5 years Kaplan Meier estimates and 95% Confidence Intervals are reported below.
Up to 5 years post-registration

Secondary Outcomes (2)

Response Rate
Up to 5 years post-registration
Overall Survival Rate at 2 and 5 Years
Up to 5 years post-registration

Other Outcomes (1)

Whether the Gene Expression Signatures That Were Previously Associated With Survival Following CHOP Therapy Are Associated With Survival in Either of the Treatment Arms of the Prospective Trial
Up to 5 years post-registration

Study Arms (2)

Arm A - R-CHOP

ACTIVE COMPARATOR

Patients receive the following treatment: * Rituximab 375 mg/m\^2 IV infusion on Day 1 prior to CHOP chemotherapy * Cyclophosphamide 750 mg/m\^2 IV on Day 1 * Doxorubicin 50 mg/m\^2 IV on Day 1 * Vincristine 1.4 mg/m\^2 IV (2 mg cap) on Day 1 * Prednisone 40 mg/m\^2/day PO on Days 1-5 * filgrastim or pegfilgrastim as defined in the protocol Required ancillary medications is administered during all cycles as defined in the protocol. Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.

Biological: rituximabDrug: cyclophosphamideDrug: doxorubicinDrug: vincristineDrug: prednisoneDrug: filgrastimDrug: pegfilgrastim

Arm B - DA-EPOCH-R

EXPERIMENTAL

Patients receive the following treatment: Cycle 1 Doses: * Rituximab 375 mg/m\^2 IV infusion on Day 1 prior to EPOCH chemotherapy * Doxorubicin 10 mg/m\^2/day CIVI on Days 1-4 * Etoposide 50 mg/m\^2/day CIVI on Days 1-4 * Vincristine 0.4 mg/m\^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours) * Cyclophosphamide 750 mg/m\^2 IV on Day 5 (following completion of 96 hour infusions) * Prednisone 60 mg/m\^2 PO BID on Days 1-5 * Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC \> 5000 after the nadir (nadir usually between Days 10-12) or for 10 days (Days 6-15) if the ANC is not being monitored, during every cycle. Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle. Required ancillary medications are administered during all cycles as defined in the protocol. Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.

Biological: rituximabDrug: cyclophosphamideDrug: doxorubicinDrug: vincristineDrug: prednisoneDrug: etoposideDrug: filgrastim