NCT00086801|CompletedPhase 2

Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage I or Stage II Hodgkin's Lymphoma

Phase II Trial of Doxorubicin, Vinblastine, and Gemcitabine (AVG) Chemotherapy for Non-Bulky Stage I and II Hodgkin's Lymphoma

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

CALGB-50203U10CA031946CDR0000370870

Study Type

interventional

Target

104

Locations

1 country

Sites

Timeline

RegisteredJul 2004

StartedMay 2004

CompletionMay 2011

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vinblastine, and gemcitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed stage I or stage II Hodgkin's lymphoma.

Trial Health

On Track

Trial Health Score

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

Enrollment

104

participants targeted

Target at P75+ for phase_2 lymphoma

Timeline

Completed

Started May 2004

Typical duration for phase_2 lymphoma

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

7 years study duration

Study Start

First participant enrolled

May 1, 2004

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2004

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed

4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed

Last Updated

July 1, 2016

Status Verified

June 1, 2016

Enrollment Period

2.8 years

First QC Date

July 8, 2004

Last Update Submit

June 30, 2016

Conditions

Lymphoma

Keywords

stage I adult Hodgkin lymphomastage II adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

Response
24 weeks

Study Arms (1)

doxorubicin + vinblastine + gemcitabine

EXPERIMENTAL

Patients receive doxorubicin IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and gemcitabine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients undergo fludeoxyglucose F 18 positron-emission tomography (PET) scanning and CT scan before treatment and after courses 2 and 6 of therapy to assess response. Patients with a positive PET scan after completion of study therapy may undergo biopsy. A PET scan is performed 3 months later if biopsy is negative or biopsy is unable to be performed. Patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.

Drug: doxorubicin hydrochlorideDrug: gemcitabine hydrochlorideDrug: vinblastineProcedure: fludeoxyglucose F 18 positron-emission tomography (PET) scanProcedure: CT scan