Status:
TERMINATED
CHOP-Rituximab Augmented With GM-CSF in Patients With Previously Untreated Diffuse Large B Cell Non-Hodgkin's Lymphoma
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Conditions:
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary goal of this study is to determine the effects (good and bad) of Granulocyte-macrophage colony stimulating factor (GM-CSF) in combination with Cytoxan, Adriamycin, Vincristine, Prednisone,...
Detailed Description
* Study treatment is divided into 21-day time periods called cycles. Almost all participants will be treated as outpatients unless they have an existing medical problem that requires them to be treate...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of diffuse large B cell Non-Hodgkin's lymphoma with characteristic immunophenotypic profile
- Patient has not received any prior anti-cancer therapy for lymphoma
- Tumor tissue confirmed to express the cluster of differentiation antigen 20 antigen by flow cytometry or immunohistochemistry
- Measurable disease as defined by a tumor mass of 1cm or greater in one dimension
- Stage II (abdominal-not radiotherapy appropriate), III, or IV disease
- Age \> 18 years
- Performance Status of 0-2
- Laboratory parameters as outlined in protocol
- Patient agrees to use birth control
Exclusion
- Known central nervous system involvement by lymphoma
- Serious uncontrolled concurrent illness such as active coronary artery disease, severe lung disease, heart failure, active alcohol abuse, active concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix
- Any evidence of prior natural exposure to Hepatitis B
- Active rheumatologic disease which may be exacerbated by GM-CSF
- Cardiac ejection fraction less than 45%
- Known HIV disease
- Patient is pregnant or nursing
- Patient is receiving other investigational drugs
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00455897
Start Date
December 1 2006
End Date
July 1 2011
Last Update
January 18 2018
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215