NCT00582725

Brief Summary

Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, and prednisone), with GM-CSF.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2002

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

December 13, 2019

Status Verified

May 1, 2014

Enrollment Period

3.8 years

First QC Date

December 19, 2007

Last Update Submit

December 12, 2019

Conditions

Lymphoma, Large B-Cell, Diffuse

Keywords

DLBCL, Elderlypreviously untreated DLBCL in the elderly

Outcome Measures

Primary Outcomes (1)

  • Response Rate to Therapy

    Dec 2005 approx

Study Arms (1)

R-CHOP + GM-CSF

EXPERIMENTAL

R-CHOP therapy (6-8 cycles) with GM-CSF

Drug: R-CHOP+GM-CSF

Interventions

R-CHOP+GM-CSFDRUG

addition of GM-CSF

R-CHOP + GM-CSF

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed, CD20+ B cell diffuse large cell lymphoma, with measurable or evaluable disease
  • Having no prior chemotherapy, immunotherapy or radiotherapy except for one cycle of CHOP or R-CHOP.

You may not qualify if:

  • Pregnant
  • Hepatitis B Surface Antigen positive
  • Have known CNS disease or HIV infection
  • Have NY Classification III or IV disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

  • Kahl BS, Bailey HH, Smith EP, Turman N, Smith J, Werndli J, Williams EC, Longo WL, Kim KM, McGovern J, Jumonville A. Phase II study of weekly low-dose paclitaxel for relapsed and refractory non-Hodgkin's lymphoma: a Wisconsin Oncology Network Study. Cancer Invest. 2005;23(1):13-8.

    PMID: 15779863RESULT

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Brad Kahl, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 28, 2007

Study Start

March 1, 2002

Primary Completion

December 1, 2005

Study Completion

November 1, 2010

Last Updated

December 13, 2019

Record last verified: 2014-05

Locations

US(1)