CHOP-Rituximab Augmented With GM-CSF in Patients With Previously Untreated Diffuse Large B Cell Non-Hodgkin's Lymphoma

Stopped early · Phase 2

Conditions studied: Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Diffuse

In brief

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, Rituximab (CHOP-R) on diffuse Large B cell Non-Hodgkin's lymphoma (DLBCL). The standard of care for DLBCL is the combination of drugs known as CHOP-Rituximab (CHOP-R). The drugs that make up CHOP-R are the chemotherapy drugs cyclophosphamide, doxorubicin and vincristine, prednisone and rituximab. GM-CSF is a drug that stimulates the immune system by increasing the numbers of white blood cells. Previous research has shown that GM-CSF might help rituximab to be more effective in treating lymphoma.

Key facts

Study ID

NCT00455897

Run by

Massachusetts General Hospital

People needed

3

Starts

2006-12-01

Expected to finish

2011-07-01

Last updated by the study team

2018-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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