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

Phase II Trial of Rituximab-CHOP (R-CHOP) Plus GM-CSF for Previously Untreated Diffuse Large Cell Lymphoma in the Elderly

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00582725

Enrollment

Registered

2007-12-28

Start date

2002-03-31

Completion date

2010-11-30

Last updated

2019-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Keywords

DLBCL, Elderly, previously untreated DLBCL in the elderly

Brief summary

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

Detailed description

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.

Interventions

DRUGR-CHOP+GM-CSF

addition of GM-CSF

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Response Rate to Therapy	Dec 2005 approx

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026