NCT00278421|CompletedPhase 3DMC

Rituximab and Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma

Randomized Study Comparing 4 and 6 Cycles of Chemotherapy With CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) at 21-day Intervals, Both With 6 Cycles of Immunotherapy With the Monoclonal Anti-CD20-Positive B-Cell Lymphoma Aged 18-60 Years Having no Risk Factor (Age-Adjusted IPI=0) and No Large Tumor Mass (Diameter <7,5cm) [FLYER 6-6-6-4 Study]

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

Compare

5 other identifiers

CDR0000459685DSHNHL-2004-2EU-205110EUDRACT-2005-00521738DSHNHL-FLYER-6664

Study Type

interventional

Target

592

Locations

3 countries

Sites

Timeline

RegisteredJan 2006

StartedNov 2005

CompletionAug 2018

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. It is not yet known which schedule of rituximab and combination chemotherapy is more effective in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkin's lymphoma.

Trial Health

On Track

Trial Health Score

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

Enrollment

592

participants targeted

Target at P75+ for phase_3 lymphoma

Timeline

Completed

Started Nov 2005

Longer than P75 for phase_3 lymphoma

Geographic Reach

3 countries

78 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

12.8 years study duration

Study Start

First participant enrolled

November 1, 2005

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed

12.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed

Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

12.8 years

First QC Date

January 16, 2006

Last Update Submit

March 9, 2021

Conditions

Lymphoma

Keywords

contiguous stage II grade 3 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomastage I grade 3 follicular lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomastage I adult diffuse large cell lymphomastage I adult diffuse mixed cell lymphomanodal marginal zone B-cell lymphomaanaplastic large cell lymphomacontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomastage I adult immunoblastic large cell lymphomacontiguous stage II adult Burkitt lymphomacontiguous stage II mantle cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II mantle cell lymphomastage I adult Burkitt lymphomastage I mantle cell lymphomacontiguous stage II marginal zone lymphomanoncontiguous stage II marginal zone lymphomastage I marginal zone lymphomastage III marginal zone lymphomastage IV marginal zone lymphomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult immunoblastic large cell lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult immunoblastic large cell lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphoma

Outcome Measures

Primary Outcomes (1)

Time to treatment failure (TTF) measured from day 1 of course 1 of Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (CHOP) therapy up to 3 years on study with life-long follow-up
through study completion

Secondary Outcomes (6)

Complete response (CR) rate duration until first relapse
through study completion
Progression rate during treatment
through study completion
Survival
through study completion
Tumor control measured from day 1 of course 1 of CHOP therapy (non-tumor related events are censored)
through study completion
Disease-free survival measured from day 1 of course 1 of CHOP therapy
through study completion
+1 more secondary outcomes

Study Arms (2)

Interventional: 6 R-CHOP-21

ACTIVE COMPARATOR

Arm I: Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo restaging of their disease. Patients with disease progression proceed to salvage therapy off study. All other patients receive 3 more courses of R-CHOP.

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

Interventional: 4 R-CHOP-21 + 2 x R

ACTIVE COMPARATOR

Arm II: Patients receive R-CHOP as in arm I. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo restaging of their disease. Patients with disease progression proceed to salvage therapy off study. All other patients receive 1 more course of R-CHOP followed by 2 courses of rituximab alone.

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