NCT00005964|CompletedPhase 2

Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Previously Untreated Aggressive Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma

Randomized Phase II Study of Dose-Adjusted EPOCH vs. NHL-15 Chemotherapy for Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma (NHL)

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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4 other identifiers

CALGB-C59910U10CA031946CLB-C59910CDR0000067947

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredNov 2003

StartedMay 2000

CompletionMar 2006

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating aggressive non-Hodgkin's lymphoma. PURPOSE: Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have previously untreated aggressive stage II, stage III, or stage IV non-Hodgkin's lymphoma.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2 lymphoma

Timeline

Completed

Started May 2000

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

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Study Timeline

Key milestones and dates

5.8 years study duration

Study Start

First participant enrolled

May 1, 2000

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed

3.3 years until next milestone

First Posted

Study publicly available on registry

November 5, 2003

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed

Last Updated

July 13, 2016

Status Verified

July 1, 2016

Enrollment Period

5.8 years

First QC Date

July 5, 2000

Last Update Submit

July 12, 2016

Conditions

Lymphoma

Keywords

stage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult lymphoblastic lymphoma

Outcome Measures

Primary Outcomes (1)

Response rate
Up to 5 years

Study Arms (1)

Chemotherapy + prednisone + filgrastim

EXPERIMENTAL

Patients receive doxorubicin IV, etoposide IV, vincristine IV, and cyclophosphamide IV continuously over days 1-4. Patients also receive oral prednisone twice daily on days 1-5 and filgrastim (G-CSF) subcutaneously beginning on day 6 until blood counts recover. Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Biological: filgrastimDrug: cyclophosphamideDrug: doxorubicin hydrochlorideDrug: etoposideDrug: prednisoneDrug: vincristine sulfate