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R-CHOP + GM-CSF for Previously Untreated LCL in Elderly

NCT ID: NCT00582725

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2010-11-30

Brief Summary

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

Detailed Description

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The objective of this study is to estimate complete response rates for patients treated with this regimen, to assess overall response rates, event-free survival and overall survival; and to assess toxicities associated with R-CHOP + GM-CSF. Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, and prednisone), with GM-CSF.

Conditions

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Lymphoma, Large B-Cell, Diffuse

Keywords

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DLBCL, Elderly previously untreated DLBCL in the elderly

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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R-CHOP + GM-CSF

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

Group Type EXPERIMENTAL

R-CHOP+GM-CSF

Intervention Type DRUG

addition of GM-CSF

Interventions

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R-CHOP+GM-CSF

addition of GM-CSF

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Pregnant
* Hepatitis B Surface Antigen positive
* Have known CNS disease or HIV infection
* Have NY Classification III or IV disease.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brad Kahl, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University Of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 15779863 (View on PubMed)

Other Identifiers

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NCI-2011-00578

Identifier Type: REGISTRY

Identifier Source: secondary_id

HO02401

Identifier Type: -

Identifier Source: org_study_id