NCT00290667|CompletedPhase 2DMC

Rituximab and Combination Chemotherapy in Treating Older Patients With Previously Untreated B-Cell Lymphoma

2-Weekly CHOP Chemotherapy With Dose-Dense Rituximab for the Treatment of Patients Aged 61 to 80 Years With Aggressive CD-20 Positive B-Cell Lymphomas: A Phase-II/Pharmacokinetic Study (CHOP-R-ESC)

German High-Grade Non-Hodgkin's Lymphoma Study Group ClinicalTrials.gov

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5 other identifiers

CDR0000454505DSHNHL-2004-1EU-20536DSHNHL-CHOP-R-ESCEUDRACT-2005-00529-68

Study Type

interventional

Target

586

Locations

9 countries

Sites

338

Timeline

RegisteredFeb 2006

StartedFeb 2004

CompletionNov 2015

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. 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 rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with previously untreated B-cell lymphoma.

Trial Health

On Track

Trial Health Score

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

Enrollment

586

participants targeted

Target at P75+ for phase_2 lymphoma

Timeline

Completed

Started Feb 2004

Longer than P75 for phase_2 lymphoma

Geographic Reach

9 countries

338 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

11.8 years study duration

Study Start

First participant enrolled

February 1, 2004

Completed

2 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2006

Completed

4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed

7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed

1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed

Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

9.8 years

First QC Date

February 9, 2006

Last Update Submit

May 14, 2021

Conditions

Lymphoma

Keywords

contiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomastage I adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomacontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomastage I adult immunoblastic large cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomacontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult Burkitt lymphomastage I adult Burkitt lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomacontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomastage I adult diffuse mixed cell lymphomastage III adult diffuse mixed cell lymphomastage IV adult diffuse mixed cell lymphomacontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomastage I adult diffuse small cleaved cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse small cleaved cell lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (3)

Pharmacokinetics (in first 20 patients of each cohort with a distinct variation of the rituximab schedule) assessed on days -4, -1, 10, 29, 57, 99, 155, 239, 267, 295, 407, and 491 of treatment
-4 to 491 days of treatment
Safety and treatment related deaths at 3 months after study completion
3 months after study completion
Toxicity assessed by NCI criteria, adverse events, serious adverse events, protocol adherence, and treatment-related deaths at 3 months after study completion
3 months after study completion

Secondary Outcomes (5)

Time to treatment failure assessed at 2 years within the study and periodically thereafter
at 2 years within the study and periodically thereafterlif
Complete response rate assessed at 2 years within the study and periodically thereafter
at 2 years within the study and periodically thereafter
Progression rate
life-long
Survival time
life-long
Progression-free survival
life-long

Study Arms (2)

Interventional: CHOP-14 + 8 x 2-weekly rituximab

ACTIVE COMPARATOR

Arm I (2-weekly rituximab): Patients receive rituximab IV 375 mg/m\^2 (females) and 500 mg/m\^2 (males) over 4 hours on days 0, 14, 28, 42, 56, 70, 84, and 98. Patients also receive pegfilgrastim subcutaneously on day 4 of each course.

Biological: pegfilgrastimBiological: rituximabDrug: cyclophosphamideDrug: doxorubicin hydrochlorideDrug: prednisoneDrug: vincristine sulfateOther: pharmacological studyRadiation: radiation therapy

Interventional: CHOP-14 + 8 x dose-dense rituximab

ACTIVE COMPARATOR

Arm II (pharmacokinetic-based dose-dense rituximab): Patients receive rituximab IV 375 mg/m\^2 (females) and 500 mg/m\^2 (males) over 4 hours on days -1, 0, 3, 7, 14, 21, 28, and 42. Patients also receive pegfilgrastim subcutaneously on day 4 of each course.

Biological: pegfilgrastimBiological: rituximabDrug: cyclophosphamideDrug: doxorubicin hydrochlorideDrug: prednisoneDrug: vincristine sulfateOther: pharmacological studyRadiation: radiation therapy